DRY EYE TREATMENT - Semantic Scholar...Alcon Inc., Allergan and Novartis AG were found to have...
Transcript of DRY EYE TREATMENT - Semantic Scholar...Alcon Inc., Allergan and Novartis AG were found to have...
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh December 11, 2009
DRY EYE TREATMENT VERSION - II
Market and IP Survey Report (Sample report)
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh December 11, 2009
TABLE OF CONTENTS
OBJECTIVE .............................................................................................................................. 1
SUBJECT OF THE SEARCH ................................................................................................... 1
Categories of Therapeutic Products ....................................................................................... 2
SUMMARY ............................................................................................................................... 4
Key Players & Products ......................................................................................................... 5
IP Landscape ........................................................................................................................ 10
Eye Drops/Artificial Tears Category Has Maximum Patent Coverage ................................... 10
Upsurge in Filing Activity Since 2002 .................................................................................... 10
Six Major IPC Codes in IP Filings .......................................................................................... 13
Emerging Trends ...................................................................................................................... 14
SEARCH RESULTS ............................................................................................................... 15
Products and Manufacturers ................................................................................................ 16
Top Companies- Business, M&A, Partnerships and Collaborations ................................... 36
Representative IP assets and Product Availability of Top Assignees .................................. 41
Top Inventors and Representative IP Assets ....................................................................... 42
EMERGING TRENDS ............................................................................................................ 44
From IP Search .................................................................................................................... 44
From Recent Research Activities......................................................................................... 45
From Non-Patent Literature ................................................................................................. 46
APPENDIX .............................................................................................................................. 51
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 1 December 11, 2009
OBJECTIVE
The objective of this search was three fold;-
To identify companies having products on the market and under development that are related
to dry eye treatment.
To identify relevant patents and applications.
To identify filing trends of key assignees.
SUBJECT OF THE SEARCH
Dry eye syndrome, also called as Keratoconjuctivitis sicca or Xerophthalmia, is an eye disease caused
by decreased tear production by lacrimal glands or increased tear film evaporation. Typical symptoms
of the disease include dryness, burning and a sandy-gritty eye irritation. Aging and Vitamin A
deficiency are the most common causes for this disorder. The disease is diagnosed by tear break test
or Schirmer’s Test. The figure below presents an overview of treatments available for dry eye.
Overview of Dry Eye Treatment
Punctal plugs Alcohol eye drops Artificial
tears
Fatty acid
tears/
Ointments
Oral dosage
forms
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A report by MaxVal Group, Inc._Sourabh 2 December 11, 2009
Categories of Therapeutic Products
There are 4 main categories of therapeutic products used for treatment of dry eye
A. Artificial Tears
Tear replacement by topical artificial tears and lubricants is currently the most widely used
therapy for dry eye. The goal of using tear substitutes is to increase humidity at ocular surface and
to improve lubrication. Major constituents of artificial tears are hydrogels. The hydrogels make
artificial tears more viscous so they stay on the eye for longer time. Hydrogels are actually
polymers that are endowed with the property of swelling up in water and retaining the moisture.
The following hydrogels have been used in artificial tears:
o Hydroxypropyl Methylcellulose (HPMC)
o CarboxyMethycellulose (CMS)
o Polyvinyl Alcohol (PVA) and
o Carbopol
B. Punctal Plugs
After Artificial tears, punctual occlusion with plugs (shown in picture below) is one of the
common forms of invasive treatment of chronic dry eye. The most typical usage of plugs is in the
lower two puncta but some patients have plugs in all four ducts (2 lower and 2 upper). Punctal
plugs are generally made of silicone.
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C. Gels/Ointments
Ointments or gels (less thick than ointments) are most preferred alternatives to artificial tears for
moderate to chronic dry eyes. Anti- inflammatory properties and high consistency characteristics
of fatty acids are exploited in gel/ ointment based treatments for dry eye.
D. Oral Compositions
In recent years, oral dosage forms meant primarily for dry mouth disease and Sjögren‟s syndrome
have been found effective in dry eye treatment. Oral medicines currently available in the market
contain systemic cholinergic agonists such as Pilocarpine or Cevimeline which stimulate secretion
from lacrimal glands. Dietary polyunsaturated fatty acids are also being studied for treatment of
dry eyes.
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SUMMARY
A comprehensive search was performed to identify companies with relevant products and patents1
related to treatment of dry eye syndrome or keratoconjuctivitis.
Figure 1: Dry Eye Treatment- Current Landscape
1 By patents ,we mean issued and published applications
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A report by MaxVal Group, Inc._Sourabh 5 December 11, 2009
Key Players & Products
29 Companies & 49 Products
General search for companies with products for treatment of dry eye syndrome revealed a total of
twenty nine companies having forty nine2 products across four different categories in this
space.
Figure 2A: Companies & Products (with marketing status3)
# - Marketing status for a product not found. * - Marketing status for 4Punctal plugs not available.
2 In Version-I, 47 products have been listed and this version is updated with two more additional products
(Abbott and Senju Pharmaceuticals). 3 OTC - Over the counter drug & RX - Prescription drug.
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Figure 2B: Top 10 Companies Based on Number of Products
Of the top 10 players, only Allergan, Medennium and Advanced Vision Research have FDA
approved products; Allergan has 3 approved products out of the total 6 and the other 2companies
have one each.
It is to be noted that no company has products in all therapeutic categories. Only three companies-
Alcon Inc., Allergan and Novartis AG were found to have products in more than one category
viz. artificial tears/eye drops and ointments/gels.
All the above top 10 players were identified to have IP related to dry eye with Alcon leading the
landscape with 142 IP assets followed by Allergan (62) and Bausch and Lomb (40).
Ten companies, listed below, were found to have only products for dry eye treatment but no
corresponding IP assets.
Akorn Pharmaceuticals
Altacor Pharma
Aton Pharma
Corneal Science Corp
Focus Laboratories
FCI Ophthalmic
MGI Pharma
Optics Laboratories Inc
Prestige Brands
Science based health
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A report by MaxVal Group, Inc._Sourabh 7 December 11, 2009
The overall product status for dry eye treatment is shown in Figure 2C. Of the 49 products on the
market, 37 are available for over-the-counter (OTC) use while 12 are available as prescription
(Rx) drugs. These numbers indicate the widespread usage of OTC medicines.
Figure 2C: Status of Products
Note: In the above figure, clinical trials that are either terminated or related to other aspects of age related eye disease are
excluded.
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A report by MaxVal Group, Inc._Sourabh 8 December 11, 2009
Figure 3A: Overview of Companies with Products on the Market
Note: Size of circle is proportional to number of products on the market. Assignees not hyperlinked in this chart do not have websites. Companies with products under
clinical trials will be made available in Version 3.
*-Companies with FDA approved products.
ARTIFICIAL
TEARS/ EYE DROPS
32 PRODUCTS ON
THE MARKET
Alcon (4)
Allergan (4)*
Advanced Vision (1)*
Altacor Pharma (1)
Bausch& Lomb (4)
Farmigea (1)
Novartis (3)
Abbott (3)
Senju Pharma (2)
Similasan Corp (1)
Johnson& Johnson (1)
Akorn Pharma (1)
Cynacon (1)
Focus Labs (1)
Optics Labs (1)
Theralife (1)
Corneal Science Corp (1)
Prestige Brands (1)
OINTMENTS/
GELS
5 PRODUCTS ON THE
MARKET
Allergan (2)
Alcon (1)
Cynacon (1)
Novartis (1)
ORAL DOSAGE
FORMS
4 PRODUCTS ON THE
MARKET
MGI Pharma (1)
Daiichi Sankyo(1)
Biosyntrx (1)*
Science based Health (1)*
8 PRODUCTS ON
THE MARKET
Eagle Vision (1)
Oasis Medical (1)
Medennium (2)*
Aton Pharma (1)*
FCI Ophthalmics (1)*
Lacrimedics (1)*
Odyssey Medical (1)
PUNCTUM PLUGS
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Figure 3B: Overview of Products & Marketing Status
Note: FDA approved products are in bold orange
*- Marketing status for the products not available
Products and their marketing status
OTC • OPTIVE™ • REFRESH®
TheraTears NewMytear®
• MyTearMoisture A® • SYSTANE® • Blink® Tears • Tears Naturale® Free • GenTeal • Visine Tears® • Advanced Eye
Relief™ • Soothe® Lubricant
Eye Drops • Dropst ar® • Murine® Tears • Hypo Tears • Akwa Tears® • MiniDrops® • Refresh Endura • Soothe®XP • Clerz Plus Lens Drops • Aquify®
• COMPLETE® Blink-
N-Clean® • Blink Contacts® • ReNu® Rewetting
Drops • VIVA Eye Drops • Theralife Eye
RX • Clinitas Soothe • Dry Eye ReliefTM • Tears Again® • FreshKote® • Bion® Tears • Restasis®
RX • Form Fit™ • Lacrisert® • Parasol Punctal
Occluder System • Herrick Lacrimal
Plug
Others
*
• DuraPlug™ • Xsorb Plug® • Snug Plugs® • SmartPlugs™
OTC • REFRESH P.M • REFRESH
® LACRI-
LUBE®
• Tears Naturale® P.M • GenTeal Gel • Tears Again® Night &
Day™ Gel
OTC • BioTears • Hydro Eye®
RX
• Evoxac • Salagen
Artificial Tears/ Eye drops (32 Products)
Punctal Plugs (7 Products)
Ointments/ Gels (5 Products)
Oral Compositions (4 Products)
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 10 December 11, 2009
IP Landscape
Category of Eye Drops/Artificial Tears Has Maximum Patent Coverage
The technology classification
4 of patents and published applications related to dry eye treatment is
based on the following product categories:
Eye drops/artificial tears
Punctal plugs
Ointments/gels
Oral dosage forms
Figure 4 below shows that most number of patents and published applications fall under the eye
drops/artificial tears category (523), followed by oral dosage forms (235), ointments/gels (238)
and punctal plugs (163).
Figure 4: Patent Coverage for Different Formulations
523
163
238
235
Eye Drops
Punctal Plugs
Ointments
Oral forms
Upsurge in Filing Activity Since 2002
General filing trends for the last ten years (1998 to 2008), as shown in the Figure 5 below, clearly
indicate an upsurge in filing activity (based on published applications) in this space from year
2002 onwards.
4 Search strings used to identify IP assets under each category are mentioned in Appendix
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A report by MaxVal Group, Inc._Sourabh 11 December 11, 2009
Figure 5: General Filing Trends5
Alcon is the Lead Assignee with Maximum Number of Patents and Published
Applications
Assignee-wise filing trends for the period 1999-2009, shown graphically in Figure 6 below,
reveals Alcon Inc. to be the leading assignee with 134 IP assets, followed by Allergan (62),
Parion Sciences (46) and others.
Figure 6: Top 10 assignees based on IP6
5 As of Aug 05,2009
6 SS used: ((((("dry eye" or keratoconjuctivitis) and (treat* or cur* or medicin* or plug)) <in> CLAIMS))) in US
issued, US publications, EP and PCT publications as of August 05, 2009.
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A report by MaxVal Group, Inc._Sourabh 12 December 11, 2009
Figure 7 shows the graphical presentation of the patent applications related to treatment for dry eye
filed by top assignees over a period of ten years (1998-2008).
Figure 7: Filing Trends of Top 10
Assignees
Note: 2009 data is as of Aug only.
As evident from Figure 7, Alcon Inc has shown consistent filings in this space with applications
filed every year from 1998 except 2006.
Parion Sciences and Merck Co. have no products on the market or in the pipeline but they have
shown patent activity from 1999 and 2002 respectively.
Allergan, Bausch & Lomb, Johnson & Co and Novagali are emerging companies in dry eye
treatment space from 2004.
Senju Pharma shows consistent filings from 2002 except in the year 2003 & 2008.
Vertex has filings from 2003 except in the years 2004 & 2006.
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A report by MaxVal Group, Inc._Sourabh 13 December 11, 2009
Six Major IPC Codes in IP Filings
Based on our analysis, the major IPC codes in this field are found to be A61K, A61P, CO7D,
C07C, C07K, and A61F.
Figure 8 also indicates that maximum number of patents and applications that are filed under
A61K (63%) broadly translates into medical compositions followed by A61P (18%) and C07D
(8%) which define therapeutic chemical compounds and heterocyclic compounds respectively.
Figure 8: Concentration of IPC Codes
Table 1 below shows the IPC classifications filed by various assignees having products in the
market or under development. It is evident from this table that most of the companies currently
developing treatments for dry eye have filed patent applications under IPC code A61K followed
by A61F.
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Table 1: Classification of Products Under IPCs
IPC
Code Definition
Companies7 with product on
market
Companies with product
under development/ Clinical
trials
A61K
Preparations for
medical, dental, or
toilet purposes
Alcon, Allergan, Bausch and
Lomb, Novartis, Senju
Pharmaceuticals, Johnson and
Johnson, Advanced Vision
Research, Abbott, Similasan
Corp
Parion Sciences, Novagali
Pharma, Resolvyx Pharma,
Lux Biosciences, Macusight
Inc, Vertex Pharma
A61F
Prostheses; devices
providing patency,
treatment or protection
of eyes or ears;
Alcon, Allergan, Bausch and
Lomb, Johnson and Johnson
Parion Sciences, QLT Plug
delivery systems, Insite Vision
A61P
Therapeutic activity of
chemical compounds or
medical compositions
Alcon, Allergan Vertex Pharma
C07D Heterocyclic
compounds Alcon, Allergan
Parion Sciences, Vertex
Pharma
C07C Acyclic or carbocyclic
compounds Alcon, Novartis Ista Pharma
C07K Peptides Bausch and Lomb, Novartis,
Johnson and Johnson -
Emerging Trends
Analysis of recently filed patent applications (2006 onwards) revealed following four
relatively new therapeutic areas for treatment of dry eye syndrome:
Monoclonal antibodies based treatment
Eyewear with moisture pads
Application of thermal energy to meibomian glands
Use of platelet rich plasma/ cell extract
Recent research activities and non-patent literature (2006 onwards) indicate novel methods of
treating dry eye syndrome including novel drugs/compounds (e.g., tear film lipids, compounds
for proliferation of goblet cells), bioabsorbable plugs, and testosterone based gel, topical
apolipoprotein, use of latent heat, etc.
7 Unassigned assets have not been considered
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A report by MaxVal Group, Inc._Sourabh 15 December 11, 2009
SEARCH RESULTS
Figure 1 shows the current landscape on dry eye treatment.
Figure 2A gives an overview of all the product categories available for treatment of dry eye
along with the number of companies and products under each category while Figure 2B
shows the top 10 companies based on number of products available in the market.
Figure 2C shows the market and development status of all the products for dry eye treatment.
Classification of products under IPCs is given in Table 1.
An overall tabular representation of the companies and their products across various
categories for treatment of dry eye syndrome are depicted in Table 2A-D.
Figure 3A gives a pictorial summary of all the companies involved in dry eye treatment along
with their product status and Figure 3B gives the list of products across various categories viz.
OTC and RX.
Technological classification of relevant IP assets among various categories is shown
graphically in Figure 4.
A glance at the business activities, mergers/ collaborations and revenues of the top 10
assignees is given in Table 3.
Top 10 assignees and Inventors along with their representative IPs and product availability
are presented in Table 4A and Table 4B respectively.
Figure 5 shows the general IP filing trends in US for the period 1999-2009 and Figure 6 gives
an overview of the distribution of IP assets (Publications and granted) among top assignees in
this field.
Filing trends of the key assignees during 1998-2008 are shown in Figure 7.
Figure 8 gives an overall concentration of the IPC codes.
Recent activities of Universities/Institutes in dry eye treatment space have been listed in Table
5.
Emerging, relatively new therapeutic treatments for dry eyes were identified and are
represented pictorially in Figure 9.
Table 6 lists the recent non- patent references discussing novel, emerging treatments for dry
eye syndrome.
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A report by MaxVal Group, Inc._Sourabh 16 December 11, 2009
Products and Manufacturers
Table 2A: Companies Manufacturing Artificial Tears/Eye Drops
Carboxyl Methylcellulose (CMC) Artificial Tears
Note: Products are categorized based on the active ingredient gleaned from Eye digest
8.
FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).
Company Name Product Name
Marketing
Status
Exemplary IP9
No of
IP
Assets10
Product Description and Application11
(Carboxyl Methylcellulose Artificial Tears)
Allergan
OPTIVE™
FDA approved
OTC US6350442
US6984628
US5981607
US5707614
US20070299004
62
OPTIVE™ Lubricant Eye Drops is an over-the-counter artificial
tear that lubricates and hydrates eyes to provide relief from dry
eye symptoms.
REFRESH®
FDA approved
OTC
REFRESH TEARS® Lubricant Eye Drops moisturizes and relieves
dry, irritated eyes with a preservative free formula to provide
soothing effect on eyes.
8 Published by University of Illinois Eye & Ear Infirmary
9 Relevant patents and published applications identified in this search, that are related to a product category, were randomly picked and listed in this column
10 US, Europe( issued and applications) and PCT
11 Information obtained from company‟s website
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Company Name Product Name
Marketing
Status
Exemplary IP9
No of
IP
Assets10
Product Description and Application11
(Carboxyl Methylcellulose Artificial Tears)
Advanced Vision
Research, Inc.
TheraTears
FDA approved
OTC
US6432934
US20040076695
US20080020064
7
TheraTears Lubricant Eye Drops help put back the lost water,
lowering the high salt concentration, so as to wet and rehydrate
dry eyes. TheraTears provides a lubricating form of
carboxymethylcellulose that gives relief from the dryness, stinging
and burning, and sandy-gritty irritation of dry eye.
Senju
Pharmaceuticals
NewMytear®
OTC
OTC
US5185372
US7459441
US7485654
US5830913
WO2009105534
19 Lacrimal Type. Reduce and prevent dryness.
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Company Name Product Name
Marketing
Status
Exemplary IP9
No of
IP
Assets10
Product Description and Application11
(Carboxyl Methylcellulose Artificial Tears)
MyTearMoisture
A®
Polyethylene Glycol Artificial Tears
Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).
Company Name Product Name12
Marketing
Status
Representative
IP
No of IP
Assets13
Product Description and Application
(Polyethylene Glycol Artificial Tears)
Alcon laboratories
SYSTANE®
OTC
US5403598
US4039662
US4966773
EP1348427
US20090156693
134
SYSTANE® Lubricant Eye Drops reduces both the signs and
symptoms of dry eye. Provides immediate moisture and protection
to the eyes.
12
FDA approval link is provided wherever applicable. 13
US, Europe( issued and applications) and PCT
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Company Name Product Name12
Marketing
Status
Representative
IP
No of IP
Assets13
Product Description and Application
(Polyethylene Glycol Artificial Tears)
Abbott Medical
Optics
Blink® Tears
OTC
US20080273171
US20090201465
WO2007130960
EP1581211
9
Blink® Tears Lubricating Eye Drops formula replenishes tear
film at each time blink. It contains a GENTLE OCUPURE™
preservative that disappears in eyes.
Hydroxypropyl Methylcellulose (HPMC) Artificial Tears
Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).
Company Name Product Name14
Marketing
Status
Representative
IP
No of
IP
Assets15
Product Description and Application
(Hydroxypropyl Methylcellulose Artificial Tears)
Alcon laboratories
Bion® Tears
RX
US5460834
US6320062
US6696453
US7060728
WO2009064983
134
Bion® Tears temporarily relieves the burning and irritation
associated with dry eye. Bion® Tears helps restore the eye to its
natural environment, Bion® Tears contains zinc and bicarbonate,
two essential components of natural tears.
Tears Naturale® OTC Tears Naturale® Forte withTrisorb
® technology contains 3
ingredients to lock in moisture to bring relief to dry eyes. Provides
14
FDA approval link is provided wherever applicable. 15
US, Europe( issued and applications) and P�
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Company Name Product Name14
Marketing
Status
Representative
IP
No of
IP
Assets15
Product Description and Application
(Hydroxypropyl Methylcellulose Artificial Tears)
Forte
better "wettability" and slow evaporation of the tear film.
Novartis
Opthalmics AG
(merger of Ciba
Geigy and Sandoz)
GenTeal
OTC
US5597559
WO05089715
WO03017990
16
GenTeal ® PF is a hypotonic and preservative-free solution,
formulated to be a soothing lubricant. A disappearing preservative
that turns into pure water and oxygen upon contact with eye,
thereby minimizing the irritation.
Johnson &
Johnson
Healthcare
Products
Visine Tears®
OTC
US7381707
US6367929
US3991759
US20080153909
11 Visine Tears® moisturizes and soothes eyes and protects against
further irritation. Its "Natural Tears Formula" contains 10 important
ingredients found in natural tears.
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Glycerin Artificial Tears
Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).
Company Name Product Name
Marketing
Status
Representative
IP
No of
IP
Assets16
Product Description and Application
(Glycerin Artificial Tears)
Altacor Pharma
Clinitas Soothe
RX - -
Clinitas contains 0.4% sodium hyaluronate producing high
concentration of HA that ensures prolonged relief from dry,
gritty eyes caused by contact lens wear or other factors.
Bausch & Lomb
Advanced Eye
Relief™
OTC US5800807
US6348508
US6277365
US6180093
WO2009018060
40
Advanced Eye Relief Dry Eye Environmental Lubricant Eye
Drops provide instant moisture for dry and irritated eyes. Dry
Eye Environmental Lubricant Eye Drops contain 1% glycerin.
Glycerin has high water-binding properties that restore moisture to
the eyes.
Soothe® Lubricant
Eye Drops OTC
Bausch & Lomb Soothe® Lubricant Eye Drops Long Lasting
formula are clinically proven to soothe dry and irritated eyes.
This revolutionary advance in dry eye therapy provides soothing
comfort and long lasting lubrication, keeping eyes feeling fresh
throughout the day.
16
US, Europe( issued and applications) and PCT
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Company Name Product Name
Marketing
Status
Representative
IP
No of
IP
Assets16
Product Description and Application
(Glycerin Artificial Tears)
Farmigea SpA
Dropstar®
OTC
US7321000
US6056950
WO03011249
EP1408929
9 Dropstar® contains sodium hyaluronate. It acts as a lubricant and
humectants of the eye with lachrymal insufficiency.
Similasan
Corporation
Dry Eye ReliefTM
RX US5336508 4
Similasan Dry Eye Relief eye drops for dry, red eyes stimulate
the eye's natural ability to fight dryness and clear redness due to
smog, stress, age, contact lens wear, etc. The active ingredients in
Similasan Dry Eye Relief eye drops work effectively with no
known side effects and no known drug interactions.
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Polyvinyl Alcohol (PVA) Artificial Tears
Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).
Company Name Product Name17
Marketing
Status
Representative
IP
No of IP
Assets18
Product Description and Application
(Polyvinyl alcohol Artificial Tears)
Prestige Brands,
Inc
Murine® Tears
OTC - -
Murine® Tears Lubricant Eye Drops is a natural tears formula
designed to soothe and lubricate dry, irritated eyes. This product
contains six ingredients found in natural tears. It temporarily
relieves burning and irritation due to dryness of the eye and also
protects against further irritation.
Novartis
Opthalmics AG
Hypo Tears
OTC
US5597559
US7615562
US6310099
WO2008074853
16
Hypo tears for dry eye contain 1% Polyvinyl Alcohol, 1% PEG
400. Hypotonic Benzalkonium Chloride (0.01%) as preservative.
Hypo tears are also available as Preservative Free single-use vials.
Akorn
Pharmaceuticals
Inc.
Akwa Tears®
OTC - -
Akwa Tears is a solution containing polyvinyl alcohol is
formulated to moisturize the eyes. This ocular lubricant is used to
relieve burning, irritation, and discomfort of the eyes due to
dryness.
CYNACON / Tears Again® RX US4904698 2 Tears Again® drops offer a thicker consistency and spreads out
evenly across the tear film upon instillation. Tears Again® drops
17
FDA approval link is provided wherever applicable. 18
US, Europe( issued and applications) and PCT
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Company Name Product Name17
Marketing
Status
Representative
IP
No of IP
Assets18
Product Description and Application
(Polyvinyl alcohol Artificial Tears)
OCuSOFT Inc.
minimize frequent instillations.
Focus
Laboratories
FreshKote®
RX - -
FreshKote® treats All 3 Layers of the Tear Film and provides relief
by adding a lacrophilic aqueous solution which interacts properly
both with the lipid and mucin layer and a mucomimetic polymer
blend designed to achieve complete wetting.
Optics Laboratory,
Inc.
MiniDrops®
OTC - -
MiniDrops Eye Therapy, is a preservative free lubricating eye
drops for relief from dry eyes. It is also useful against minor
allergies and computer vision syndrome.
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Oil Containing Eye Drops
Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).
Company Name Product Name19
Marketing
Status
Representative
IP
No of
IP
Assets20
Product Description and Application
(Oil containing Eye Drops)
Allergan
Refresh Endura
OTC
US5474979
US5981607
US20080268051
US20080112922
62
Refresh Endura is an artificial tear that contains a castor oil
emulsion. It has uniform pale milky color. On the tear film castor
oil spreads rapidly to fortify lipid layer. This reduces evaporative
fluid loss. Carbomer 1342 is the hydrogel is an important
constituent. Polysorbate and glycerin are the other lubricants used.
Bausch & Lomb
(Acquired the
formulation from
Alimera Sciences)
Soothe®XP
Emollient
(Lubricant)
OTC
US5895645
US6610318
US20050182039
40
Bausch & Lomb Soothe® XP Emollient (Lubricant) Eye Drops
provides moisture and it contains Restoryl®, a lipid restorative
which provides a barrier to tear loss for relief up to 8 hours.
TheraLife TheraLife® Eye 6
Revitalizes and strengthens the eye's tear secretion functions.
19
FDA approval link is provided wherever applicable. 20
US, Europe( issued and applications) and PCT
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 26 December 11, 2009
Company Name Product Name19
Marketing
Status
Representative
IP
No of
IP
Assets20
Product Description and Application
(Oil containing Eye Drops)
OTC
US6383524
US6537581
WO2001091765
Contains Lutein and Zeaxanthin natural anti oxidant ingredients.
Eye Drops for Rewetting Contact lens
Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).
Company Name Product Name21
Marketing
Status
Representative
IP
No of
IP
Assets22
Product Description and Application
(Eye Drops for Rewetting Contact Lens)
Alcon laboratories
Clerz Plus Lens
Drops
OTC
US4525346
US4039662
US5075104
WO2008036855
134
Clerz Plus retains moisture and fights protein buildup. Clerz Plus
contains two ingredients i.e. Tetronic 1304 and RLM- 100 that
work together to enhance lens-wearing comfort. Clerz Plus works
with any lens care regimen.
21
FDA approval link is provided wherever applicable. 22
US, Europe( issued and applications) and PCT
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 27 December 11, 2009
Company Name Product Name21
Marketing
Status
Representative
IP
No of
IP
Assets22
Product Description and Application
(Eye Drops for Rewetting Contact Lens)
Allergan
Restasis®
(FDA Approved)
RX
US5981607
US6872705
US6024954
US5252318
US20030068250
62
RESTASIS® ophthalmic emulsion contains small concentration of
cyclosporine. It helps to increase the eyes' natural ability to
produce tears which may be suppressed by inflammation due to
chronic dry eye.
Novartis-
CIBAVISION(Cib
aVision is eye care
unit of Novartis)
Aquify®
OTC
US6827966
US6827966
US7329415
WO200589715
16
Blink-activated Aquify® Drops mimic the behavior of natural
tears. Its ingredient sodium hyaluronate slowly releases water
molecules, so the moisture lasts. Helps relieve lens-related
dryness and increases lubrication.
Abbott Medical
Optics
COMPLETE®
Blink-N-Clean®
Lens Drops
OTC
US20090247640
WO2007130960
WO2004062660
9
COMPLETE® Blink-N-Clean® Lens Drops Helps prevent
annoying protein film buildup. Removes particulate material that
can cause irritation and discomfort. Promotes lens cleanliness
during wear, lubricates and rewets contact lenses
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 28 December 11, 2009
Company Name Product Name21
Marketing
Status
Representative
IP
No of
IP
Assets22
Product Description and Application
(Eye Drops for Rewetting Contact Lens)
Blink Contacts®
OTC
Blink Contacts® Lubricating Eye Drops offers lubrication for
contact lens wearers, with improved tear-break-up-time and
increases tear film stability. It also provides protection for patients
with RGP and soft contact lenses.
Bausch & Lomb
ReNu® Rewetting
Drops
OTC
US6180093
US7067479
US5895645
US20080314767
40
ReNu® Rewetting Drops rewet lenses and help prevent film
deposit build-up. Promotes rewetting, frequent replacement,
disposable or extended wear lenses, especially after awakening.
Also help remove particulate matter.
Corneal Science
Corporation
VIVA Eye Drops
OTC - -
VIVA contains an iron chelator that scavenges for free iron in the
tears, as well as seven antioxidants, that are crucial for avoiding
free radical damage secondary to the inflammatory process. Free
radicals are released into the tears from any surgery performed on
the cornea, contact lens use, in the presence of free iron (low
Lactoferrin levels) and during any type of inflammatory process
involving the cornea and the conjunctival tissue.
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 29 December 11, 2009
Table 2B: Companies Manufacturing Punctal Plugs
Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).
Company Name Product Name23
Marketing
Status
Representative
IP
No of
IP
Assets24
Product Description and Application
(Punctal Plugs)
Aton Pharma
LACRISERT®
FDA Approved
RX - -
LACRISERT® is a small insert that is placed into the pocket of
lower eyelid. Once inserted, LACRISERT® gently begins to
dissolve within minutes. Optimal improvement is observed in 6-9
weeks.
Eagle Vision, Inc. Duraplug® NA
US5283063
US6344047
US5334137
WO2004034518
17
Duraplug® is meant for post lasik induced dry eye, seasonal dry
eye and for retention of ocular medication.
FCI Ophthalmic
Snug Plugs™
(FDA Approved,
K061398)
NA - -
Snug Plugs™ are designed to provide effective punctal occlusion
for the treatment of dry eye. Snug Plugs™ are made of medical
grade silicone and are preloaded in a stretched position, returning
to their natural shape when released in the punctum.
23
FDA approval link is provided wherever applicable. 24
US, Europe( issued and applications) and PCT
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 30 December 11, 2009
Company Name Product Name23
Marketing
Status
Representative
IP
No of
IP
Assets24
Product Description and Application
(Punctal Plugs)
Lacrimedics, Inc.
Herrick Lacrimal
Plug™
(FDA Approved,
K896175)
RX
US5171270
1
Opaque Herrick Lacrimal Plugs may be used in the treatment of
dry Eye symptoms: dryness, redness, itching, burning,
intermittent tearing or foreign body sensation. Herrick Lacrimal
Plugs are medical grade silicone, are provided sterile, and
premounted on an insertion tool.
Medennium Inc.
SmartPLUG™
(FDA Approved,
K022043)
RX
US6234175
US20060074370
EP1305061 9
SmartPLUG from Medennium is used to occlude the "punctum"
or tear duct, and conserve the eye's natural tears. SmartPLUG
is designed to fit a range of punctum sizes. Made of a flexible
thermosensitive acrylic material, SmartPLUG adjusts to the exact
shape and size of the punctum.
Xsorb™ Plug
NA
The Xsorb™ Plug provides immediate dry eye relief and
improves patient comfort. Xsorb™
temporary punctum plugs last up to three months.
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 31 December 11, 2009
Company Name Product Name23
Marketing
Status
Representative
IP
No of
IP
Assets24
Product Description and Application
(Punctal Plugs)
Oasis Medical Inc. Form Fit™
RX US5766243 2
The Form Fit™ plug is made of a hydrogel material that
expands into a soft, pliable, gelatinous material when it contacts
tear film. Once inserted into the punctum, Form Fit™ hydrates
over a 10 minute period.
Odyssey Medical
Parasol® Punctal
Occluder System
(FDA Approved,
K972523)
RX US5830171
US6527780 3
Parasol Punctal Occluder System consists of a hollow nose
structure to ease insertion and offers distinct advantages to dry
eye patients.
Table 2C: Companies Manufacturing Ointments & Gels
Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).
Company Name Product Name25
Marketing
Status
Representative
IP
No of
IP
Assets26
Product Description and Application
(Ointments & Gels)
Allergan
REFRESH P.M.®
OTC
US5808083
US6254860
US7045121
US20050271748
62
REFRESH P.M. ®
Lubricant Eye Ointment provides strong,
soothing nighttime relief for more intense dry, irritated eyes.
REFRESH P.M. ®
is a preservative-free lubricant eye ointment that
is ideal for use at bedtime.
25
FDA approval link is provided wherever applicable. 26
US, Europe( issued and applications) and PCT
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 32 December 11, 2009
Company Name Product Name25
Marketing
Status
Representative
IP
No of
IP
Assets26
Product Description and Application
(Ointments & Gels)
REFRESH®
LACRI-LUBE®
OTC
REFRESH® LACRI-LUBE
® Lubricant Eye Ointment provides
strong, soothing nighttime relief for more intense dry, irritated
eyes and is ideal for use at bedtime.
Alcon laboratories
Tears Naturale®
P.M.
OTC
US5075104
US4966773
US5403841
US4525346
WO2008052031
134
Tears Naturale® P.M. is a lubricant that prevents further irritation
and relieves dryness of the eye. It forms a smooth, protective film
that provides protection and comfort to the eyes.
Novartis
Opthalmics AG
GenTeal Gel
OTC
US6291523
US6670379
US7615562
US20080312212
11
The GenTeal PM Ointment formulation contains the high
concentration of moisture for use at night time. GenTeal provides
advanced hydration for dry eye relief.
CYNACON /
OCuSOFT Inc.
Tears Again®
Night & Day™ Gel OTC US4904698 2
Tears Again® Gel offer a thicker consistency than most drops yet
spread out evenly across the tear film upon instillation. Tears
Again® Gel minimizes frequent instillations providing greater
economy. Tears Again® Night & Day™ Gel is recommended for
moderate to severe conditions of dry eye.
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 33 December 11, 2009
Company Name Product Name25
Marketing
Status
Representative
IP
No of
IP
Assets26
Product Description and Application
(Ointments & Gels)
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 34 December 11, 2009
Table 2D: Companies Manufacturing Oral Compositions
Note: FDA approval link is provided in the product name column, most of the products listed in these Tables are available over the counter (OTC).
Company Name Product Name27
Marketing
Status
Representative
IP
No of IP
Assets
Product Description and Application
(Oral Compositions)
Biosyntrx Inc
BioTears
OTC
US7029712
2
BioTears are oral gel caps which reduce tear film
inflammatory markers IL-1 and 6. It targets tear-specific
inflammatory processes. Addresses the tear film structure
necessary for optimal visual clarity.
Daiichi Sankyo
Evoxac
(FDA Approved)
RX US6287596 3
The active ingredient of Evoxac is cevimeline. It stimulates
secretion from Lacrimal gland. It has been approved by FDA
for treatment of dry mouth, Sjoergen‟s syndrome and dry eyes
as well.
MGI Pharma
(BIPI
Manufacturing for
MGI pharm.)
Salagen
(FDA Approved) RX - -
The active ingredient of Salagen is pilocarpine. It stimulates
specific receptors in Lacrimal gland and cause increased
secretion of tears.
27
FDA approval link is provided wherever applicable.
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 35 December 11, 2009
Company Name Product Name27
Marketing
Status
Representative
IP
No of IP
Assets
Product Description and Application
(Oral Compositions)
Science Based
Health
Hydro Eye®
OTC - -
Hydro Eyes contain Omega-3 EPA and DHA. It is
recommended for dry eye treatment for discomfort due to
age, tear deficiency, lasik surgery or other reasons.
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 36 December 11, 2009
Top Companies- Business, M&A, Partnerships and Collaborations
Table 3
Company Revenue/Sales Partnerships/Collaborations (since 2005)
Alcon
(a subsidiary
of Nestle, S.A.,)
M&A28
Alcon to acquire
Swiss biotech firm,
ESBATech AG (Sep.
2009)
Novartis may opt out
of Alcon deal (June
2009)
Business Focus:
Eye Care
(3 main business
divisions- surgical,
pharmaceutical and
consumer vision care)
$1.04 billion (as
of 06/2009)
Jul. 2009
Alcon commences Phase 2 clinical trial of NovaBay‟s
NVC-422 for viral conjunctivitis
Alcon and Astrazeneca to collaborate on Eye Drug
Development
Oct. 2008
Alcon expands licensing agreement with GSK for global
ophthalmic rights to Cilomist
Jul. 2006
Eli Lily and Alcon sign marketing collaboration for
potentially the first oral medication for diabetic
retinopathy
Origenis and Alcon- research partnership
Apr. 2006
Alcon and Amgen sign collaboration agreement to
develop and commercialize innovative therapies in
Ophthalmology
Jan. 2006
Kalypsys, Inc announces small molecule research
collaboration with Alcon
Oct. 2005
Dharmacon and Alcon enters RNAi collaboration
Jan. 2005
Jerini AG announces research collaboration with Alcon
Allergan
M&A
Allergan completes
merger agreement
with Inamed Corp.
(Dec. 2005)
Business Focus:
Allergan is a global
pharmaceutical
Allergan
estimates $500
million and
$510 million for
the year 2009
on its product -
Restasis
Sep. 2009
Pieris AG enters into Anticalin collaboration with
Allergan, Inc
Sep. 2006
Syntaxin (a biopharmaceutical company) expands its
strategic alliance with Allergan for novel therapeutic
compounds
Oct. 2005
Sirna Therapeutics and Allergan enter into strategic
Ophthalmic Alliance (Sirna out-licensed Phase I AMD
28
Only recent (post 2007) M&A activities are reported
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 37 December 11, 2009
Company Revenue/Sales Partnerships/Collaborations (since 2005)
company focused on
ophthalmics,
neurology,
dermatology and
urologics.
drug sirna-027 to Allergan)
Parion Biosciences
Business Focus:
Development-stage
Pharmaceutical
company focused in
treatment of defective
mucosal surfaces
(e.g., COPD, Cystic
Fibrosis and
Bronchiectesis)
Not found
Dec. 2008
Parion receives NIH biodefense grant ($850,000) to study
novel methods for mitigating radiation-induced lung
injury
Parion announces initiation of Phase I clinical trial to
evaluate safety and tolerability of GS9411; receives
$5million milestone payment from Gilead sciences
Oct. 28, 2008
Kainos Medicines, Inc to fund up to $25 million to
advance P-552 used in the treatment of dry mouth
treatment
Bausch & Lomb
Business Focus:
Eye care
M&A
B&L acquires
commercial assets of
Italian Ophthalmic
pharmaceuticals
company Tubilux
(Oct. 2009)
B&L completes
acquisition of
Eyeonics, Inc
(Feb. 2008)
Warburg Pincus
completes acquisition
of B&L (Oct. 2007)
Bausch &
Lomb projects
2007 sales of
approximately
$2.5 billion29
Sep. 2009
Bosch & Lomb subsidiaries and CROMA will co-
promote Bromfenac ophthalmic solution in Europe
April 2009
Bausch & Lomb and Pfizer Inc. will copromote
ophthalmic drugs in the United States
Apr. 2008
B&L and Galapagos NV (a drug discovery company) sign
agreement to collaborate on ophthalmic disease research
Jan. 2008
R&D collaboration with Crystalgenomics to study
potential new treatments for inflammatory ophthalmic
diseases
Jan. 2007
Alliance with Acufocus, Inc for presbyopic correction
technology
Sep. 2006
B&L licenses SEGRA compound from Schering AG for
ophthalmic use
Vertex Pharma
Business Focus:
Cash balance -
$754 million as
of June 2009.
9 drugs in
Nov. 2009
Bend Research enters collaboration with Vertex
Pharmaceuticals
29
2009 income/sales is not available
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 38 December 11, 2009
Company Revenue/Sales Partnerships/Collaborations (since 2005)
Biopharmaceutical
company focused on
drug development for
Cystic fibrosis,
inflammatory diseases
and cancer.
M&A
Vertex
Pharmaceuticals
closes on acquisition
of Virochem Pharma
(Mar. 2009)
pipeline.
Jun. 2006
Janssen Pharmaceutica announces collaboration with
Vertex to develop and commercialize VX-950 for
treatment of Hepatitis C
Mar. 2006
Vertex and Cystic Foundation Therapeutics enter
collaboration to develop oral drug candidate VX-770 for
CF
Caprion Pharmaceuticals announces new biomarker
discovery collaboration with Vertex
Dec. 2005
GSK, Vertex collaborate to develop VX-409 for the
treatment of pain
Johnson & Johnson
(includes Vistakon, a
division of J&J Vision
care)
Business Focus:
Healthcare company.
(3 main business
divisions- medical
devices ,
pharmaceutical and
consumer health care)
M&A
J&J completes
acquisition of Cougar
Biotechnology (a
oncology company)
(July 2009)
J&J buying cosmetic-
product and implant
maker, Mentor Corp.
for $1.07 billion (Dec.
2008)
Israels‟s Omrix gets
$15.1billion for
Q3 (as of Oct
2009)
Sep. 2009
J&J and Crucell N.V. announce strategic collaboration,
J&J acquires 18% stake (collaboration focusing on
monoclonal antibodies and vaccines for prevention of
influenza and other infectious and non-infectious
diseases)
Jul. 2009
Collaboration between Gilead Sciences and Tibotec unit
of J&J to develop a new single-pill HIV treatment
Oct. 2008
WuXi Pharma Tech expands J&J collaboration in the
integrated research services
Sep. 2007
Isis and J&J ink diabetes drug deal
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 39 December 11, 2009
Company Revenue/Sales Partnerships/Collaborations (since 2005)
acquired by J&J (Nov.
2008)
Inspire Pharma
Business Focus:
Biopharmaceutical
company focused on
development and
commercialization of
prescription products
for ophthalmic and
pulmonary diseases.
Inspire reports a
revenue of
$25.2 million
for the third
quarter of 2009
Oct. 2008
Inspire Pharma announces issuance of patent for
Elestat®
Nov. 2004
Inspire Pharma licenses novel glaucoma technology from
Wisconsin Alumni Research Foundation; addition of new
ophthalmic program enhances pipeline
Dec. 2003
Allergan and Inspire enter into collaboration to co-
promote Elestat (FDA approved in Oct. 2003; used to
prevent itching associated with allergic conjunctivitis) in
U.S.
Senju Pharma
Business Focus:
Japan based
Pharmaceutical
company with
marketing
collaborations
worldwide. Focused
on OTC medicines
and animal science.
Total sales
¥21.1 billion
($2.4 million)
(for year ending
2008)
Jul. 2009
Senju obtains marketing rights to Gatifloxacin ophthalmic
solution in China from Kyorin Pharmaceutical Co. Ltd.
Aug. 2006
ISTA pharmaceuticals acquired exclusive North
American rights to investigational ophthalmic therapy
(Senju‟s Bepotastine) for allergic conjunctivitis
Jun. 2006
ISTA pharma acquires rights to two glaucoma drug
candidates from Senju Pharma
Nov. 2005
Novartis signed a global and commercialization
agreement with Senju for Y39983, drug designed to
topically treat glaucoma
June 2004
Allergan and Senju sign joint marketing agreement.
Merck
Business Focus:
Merck is a
pharmaceutical giant
with over $60 billions
in revenue. Four
ophthalmic products
in market.
Total sales $6.0
billion for Q3,
2009.
Apr. 2009
Merck & Co., Inc. and Santen Sign Licensing Agreement
In Ophthalmology
Jan. 2008
Merck & Co has expanded its licensing agreement with
SurModics
May 2006
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 40 December 11, 2009
Company Revenue/Sales Partnerships/Collaborations (since 2005)
M&A
Merck Acquire
Schering-Plough
(Mar. 2009)
Merck acquires
Serono for €10.4bn
(Sep. 2006)
Harvard Medical signs agreement with Merck to develop
potential therapy for macular degeneration
Novagali Pharma
Business Focus:
Novagali is a France
based developmental
stage ophthalmic drug
company.
Not found
Oct. 2008
Novagali gets 15M-euro in new funding round.
Apr. 2007
Topigen Pharmaceuticals Inc. and Novagali Pharma Enter
Into Strategic Collaboration for Allergic Ocular Diseases
and Allergic Rhinitis
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 41 December 11, 2009
Representative IP assets and Product Availability of Top Assignees
Table 4A
Assignee Representative IP No. of IP Assets30
Product
Availability
Alcon Inc
US4966773
EP1348427
US20090156693
134
Allergan
US5981607
US5707614
US20070299004
62
Parion Sciences
US6903105
US7388013
US2008096896
46 X
Bausch& Lomb Inc.
US5591426
US6277365
WO2009089401
40
Vertex Pharma US7553855
WO2009076593A1
37 X
Johnson& Johnson
US6367929
US7037517
US7381707
22
Inspire Pharma US6277855
US7528119
21 X
Senju Pharma
US5185372
US7459441
US2007093513A1
19
30
US, Europe( issued and applications) and PCT
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 42 December 11, 2009
Assignee Representative IP No. of IP Assets30
Product
Availability
Merck& Co. US7053085
US7238710 16 X
Novagali Pharma
US6656460
US2009124565A1
US2009170944A1
13 X
Top Inventors and Representative IP Assets
Table 4B: Top 10 Inventors31
Top Inventors Associated
Assignee
No. of IP
Assets Representative IP
Johnson,
Michael R Parion Sciences 54 US6903105: Sodium channel blockers
Klimko, Peter,
G. Alcon Inc 31
US6331644: 3-heteroatom substituted and two
carbon homologs of 15-HETE and methods of
use
Ruah; Sara S.
Hadida
Vertex
Pharmaceuticals 28
WO05035514: Modulators Of ATP-Binding
Cassette Transporters
Yanni, John.M. Alcon Inc. 26
US5696166: Phenyl or heteroaryl and
tetrahydronaphthyl substituted diene compound
having retinoid like biological activity
Yerxa,
Benjamin, R. Inspire Pharma 25
US6277855: Method of treating dry eye disease
with nicotinic acetylcholine receptor agonists
Dalton, James T. GTX Inc. 23 US2003225040: Selective androgen receptor
modulators and methods of use thereof
31
SS used: ((((("dry eye" or keratoconjuctivitis) and (treat* or cur* or medicin* or plug)) <in> CLAIMS))) in
US issued, US publications, EP and PCT publications
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 43 December 11, 2009
Top Inventors Associated
Assignee
No. of IP
Assets Representative IP
Gamache Daniel
Alcon Inc. 23
EP1393277: Use of NF-kappa-b inhibitors to
treat dry eye disorders
Chandraratna ,
Roshantha A.
Allergan 21
US5183827: Acetylenes disubstituted with a
heteroaromatic group and a 2-substituted
chromanyl, thiochromanyl or 1,2,3,4-
tetrahydroquinolinyl group having retinoid-like
activity
Ueno, Ryuji R-Tech Ueno Ltd. 20 US6403598: Ophthalmic composition
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 44 December 11, 2009
EMERGING TRENDS
From IP Search
Four relatively new therapeutic areas (based on recent filings and scientific literatures) for
treatment of dry eye syndrome were identified and assignees employing them with their IP assets
are presented in Figure 9 below.
Figure 9: Emerging Technologies
Representative patent applications disclosing new technologies include,
Application of monoclonal antibodies targeting receptors in lacrimal gland is disclosed in
patent application US2008292637 assigned to Canfite Biopharma.
Use and efficacy of silicone gel moisture pads prevent evaporation of tears thereby
improving dry eye condition is disclosed in patent application US2006157064 assigned to
Suzanne Davison et al.
NEW TECHNOLOGIES
D R Y E Y E
Monoclonal antibodies based treatment US2008292637 (Assignee: Can Fite Biopharma)
Eyewear with moisture pads US2006157064 (Assignee: Suzanne Davison et al.)
Application of thermal energy US20080109052 (Assignee: Grenon Stephen M)
Using platelet rich blood plasma/cell extracts WO2008023026 (Assignee: Turzi Antoine)
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 45 December 11, 2009
One patent application US20080109052 assigned to Grenon Stephen discloses
delivering of thermal energy to meibomian gland for comforting dry eyes.
One PCT application WO2008023026 assigned to Turzi Antoine discuss the role of
platelet rich plasma and cell extracts for treatment of dry eyes.
From Recent Research Activities
Six research institutes/ universities were identified (since 2008) to be involved in research focused
on dry eye treatment. These institutes along with their research areas are listed in Table 5.
Two institutions- Institute for Eye Research and University of Illinois are
independently investigating novel drugs for dry eyes based on tear film lipids and
immunologic-mediating chemicals respectively.
Southern California College of Optometry is studying meibomian gland dysfunction to
develop novel formulations for dry eye. The Institute recently licensed Testosterone based
gel for dry eyes to Argentis Pharma.
University of Florida has developed new bioabsorbable punctal plugs and is seeking
companies interested in commercializing the product.
University of Virginia is developing novel contact lens for delivering lacritin (a protein
regulating tear formation) to dry eyes.
Schepens Eye Research Institute has patented novel compounds for proliferation of
Goblet cells and is working on developing eye drops/ contact lenses based on these
compounds. The institute is currently looking for companies to license this technology.
Table 5: Recent Research Activities (since 2008) of Universities/Institutes
Note: Hyperlinks are linked with the respective web source pages.
Universities/Institutes Recent Activities32
Institute for Eye
Research
Institute for Eye Research in collaboration with the University of Wollongong
and University of New South Wales has opened an Australian Research Council
(ARC) linkage grant that will support a collaborative project investigating tear
film lipids. This investigation will lead to development of new treatments for dry
eye and novel technologies that provide greater comfort for contact lens wearers.
Southern California
College of Optometry
Currently center for vision research at SCCO engaged in several dry eye studies
include, development of a video meibography method of assessing oil gland
(called “meibomian” gland) dysfunction, residence time of novel formulations in
dry eye, etc.
32
Information listed in this table are as described in the web source pages
SAMPLE REPORT Draft
A report by MaxVal Group, Inc._Sourabh 46 December 11, 2009
Universities/Institutes Recent Activities32
University of Florida
University of Florida has created an efficient punctal plug that can deliver dry
eye medication at a continuous rate for an extended period of time. Currently
they are seeking companies interested in commercializing such an improved
punctal plugs that deliver medication to dry eye patients with greater efficiency
and effectiveness.
University of Illinois
Medical Center
UIC Eye Center is trying to find the best methods of treatment for dry eyes by
testing different types of artificial tears as well as chemicals that may stimulate
tear secretion. They are also testing immunologic-mediating drugs that may
decrease the dry eye complications in some diseases and also are developing new
medical and surgical treatments to manage the dry eye conditions.
University of Virginia
University of Virginia is currently working on developing novel contact lens
technologies for delivering lacritin – a novel drug to regulate the dry eye
condition which autostimulates „basal tearing. Lacritin is itself a component of
tears, and is 1 of only 7 tear proteins selectively downregulated in dry eye tears.
Schepens Eye
Research Institute
The institute has cultured and characterized goblet cells and invented novel
compounds for proliferation of goblet cells. The compounds of the invention
could be administered as drops or added to contact lenses to improve dry eye
condition. Schepens Eye Research Institute has patented the technology under
US patents 7052690 and 7316927 and is currently available for licensing.
From Non-Patent Literature
Table 6: Non-Patent References on Dry Eye Treatment (since 2005)
Note: Non-patent references listed in this table are related to novel technologies in dry eye treatment. Texts
related to subject matter are highlighted in bold italics.
S. No. Bibliographic Details (Journals, White Papers, Conferences)
1
Topical Apolipoprotein A-1 May Have a Beneficial Effect on the Corneal Epithelium in a
Mouse Model of Dry Eye: A Pilot Study
Nyunt Aung Kyaw, Ishida Yusuke, and Shimada Shoichi
Publication: Eye & Contact Lens: Science & Clinical Practice; Vol. 34, Issue 5
Publication Date: Sep 2008
Technology: Dry eye syndrome treatment using ApoA-1 with d-pantethine.
Abstract
Dry-eye syndrome affects millions of individuals and it is essential to develop effective
therapeutic agents for the treatment of this complex condition. The goal of this study was to
evaluate the effect of apolipoprotein A (ApoA)-1 and its synergistic action with d-
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S. No. Bibliographic Details (Journals, White Papers, Conferences)
pantethine (DP) on corneal epithelial disorders in dry-eye mouse model. Methods.
Aqueous tear production of C57BL/6J Jms Slc male mice aged 10 to 12 weeks were
inhibited by subcutaneous scopolamine injection and mice were placed in a continuous
airflow blower to create desiccating environmental stress. During desiccation, 1 eye of each
mouse was treated with ApoA-1 (0.01%, 0.04%, or 0.1%) or ApoA-1 (0.04%) + DP (0.05%,
0.1%, or 0.2%) and the other control eye was instilled with phosphate-buffered saline 4
times daily for 5 days. Phenol red thread test, corneal fluorescein staining (score, 0-4), and
measurement of corneal epithelial thickness measurements were performed. Results.
Significant reductions of staining scores and higher corneal epithelial thickness values were
observed in both ApoA-1- and ApoA-1 + DP-treated groups compared with untreated dry-
eye mouse and phosphate-buffered saline-treated group. Conclusions. These results suggest
that ApoA-1 and DP may be potential therapeutic agents for ocular surface epithelial
disorders in patients with dry eye.
2
Symptomatic Dry Eye Treatment with Autologous Platelet-Rich Plasma
Jorge L. Alio, José R. Colecha, Silvia Pastor and Alberto Artola
Universidad Miguel Hernandez, Spain
Publication: Ophthalmic Research; Vol. 39, Issue 3
Publication Date: Nov 2007
Technology: Autologous platelet-rich plasma in dry eye treatment.
Abstract
Background: Autologous platelet-rich plasma (PRP) has been proven to be very effective on
tissue regeneration and wound healing. Here we investigate the potential use of PRP in the
treatment of symptomatic dry eye. Methods: Eighteen consecutive patients with
symptomatic dry eye were treated with topical PRP and followed up for 1 month.
Disappearance of subjective symptoms, increase in best corrected visual acuity, tear
meniscus, tear breakup time, decrease in inflammation, fluorescein staining and
improvement in impression cytology were measured. Results: Symptoms improved
significantly in 89% of the patients, 28% improved at least 1 line of best corrected visual
acuity. A significant improvement on lachrymal meniscus and conjunctival hyperemia and a
decrease or disappearance of corneal fluorescein staining was observed. Impression cytology
revealed a significant increase in conjunctival goblet cells. Conclusion: Treatment of
patients suffering from significant dry eye symptoms with autologous RPR proved to be
very effective, improving both patient symptoms and major clinical signs.
3
Use of silicone hydrogel material for daily wear
Michel Guillon, Cécile Maissa
Optometric Technology Group Research & Consultancy, UK
Publication: Contact Lens and Anterior Eye; Vol. 30, Issue 1
Publication Date: Mar 2007
Technology: galyfilcon A and alphafilcon in contact lens to improve eye wettability.
Abstract
Silicone hydrogel contact lenses were initially developed to optimize oxygen transmissibility
for extended wear use. The concerns with such contact lenses have been their higher
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S. No. Bibliographic Details (Journals, White Papers, Conferences)
elastomeric and hydrophobic characteristics associated with the incorporation of silicone
type monomers. The use of silicone hydrogel has most recently been suggested for daily
wear to eliminate all hypoxic related problems. The primary aim of the investigation was to
test in vivo wetting performance and subjective acceptance of the first silicone hydrogel
contact lens developed for daily wear, ACUVUE® ADVANCE™ with HYDRACLEAR™
(galyfilcon A), compared to a conventional hydrogel contact lens for the same application
SofLens®66 (alphafilcon A).
The investigation was a randomized, subject masked bilateral cross over investigation testing
of the two contact lens materials over their approved replacement periods (galyfilcon A 2
weeks and alphafilcon A 2 weeks (USA) and 4 weeks (Europe)). In all cases ReNu
Multiplus® lens care system was used.
The investigation carried out on 24 contact lens wearers showed that: (i) in vivo wettability
was superior for galyfilcon A which had a thicker lipid layer (thin layer incidence: galyfilcon
A 54%; alphafilcon A 70–86%, p < 0.05), a thicker aqueous layer (thick layer incidence:
galyfilcon A 88%; alphafilcon A 35–64%, p < 0.05) and a more stable tear film (galyfilcon
A 7.8 s; alphafilcon A 2 weeks 5.6 s, p = 0.022; 4 weeks 7.4 s, p = 0.276); (ii) for the
intended replacement period, comfort was better with galyfilcon A (2 weeks) compared to
alphafilcon A (4 weeks) at insertion (p = 0.001) and, throughout the day (daytime and
evening p = 0.008).
Contact lenses made from galyfilcon A and replaced two weekly achieved better in vivo
wettability than contact lenses made from alphafilcon A and replaced either two or four
weekly; the better wettability was associated with an overall better comfort for galyfilcon
A.
4
Mechanisms of autoantibody production and the relationship between autoantibodies and the
clinical manifestations in Sjögren‟s syndrome
Hideki Nakamura, Atsushi Kawakami and Katsumi Eguchi
Nagasaki University, Japan
Publication: Translational Research; Vol. 148, Issue 6
Publication Date: Dec 2006
Technology: Auto antibodies in Sjögren‟s syndrome.
Abstract
The major target organs of Sjögren’s syndrome (SS) are lacrimal glands and salivary
glands where prominent lymphocytic infiltration occurs, which may induce varying levels of
autoantibody production. Multiple factors, including environmental stress, viral infection,
hormonal imbalance, and apoptosis, are thought to be involved in the pathogenesis of SS.
Production of anti-SS-A/Ro and anti-SS-B/La antibodies is thought to be regulated by the
presentation of autoantigens in context with an aberrant expression pattern of human
leukocyte antigen (HLA) in situ. Molecular mimicry with some viral sequences is also
hypothesized. The apoptosis-resistance phenotype of B cells in labial salivary glands (LSGs)
of SS is important in autoantibody production. CD40/CD40L (CD40 ligand) and Bcl-2
family proteins, in tandem with B cell-activating factor (BAFF), are supposed to protect
infiltrating lymphocytes from apoptosis. Anti-muscarinic3 receptor antibody plays an
important role in cholinergic hyperresponsiveness in SS. Fragmentation of autoantigens such
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S. No. Bibliographic Details (Journals, White Papers, Conferences)
as SS-B/La or alfa-fodrin during the process of apoptosis causes the redistribution of these
autoantigens, leading to the production of autoantibodies in SS. In this review, the role of
autoantibodies found in SS, corresponding to clinical aspects of each antibody as well as
the mechanisms of production is discussed.
5
Tear film lipid layer thickness and ocular comfort after meibomian therapy via latent heat
with a novel device in normal subjects
M. Mitra, G J Menon, A Casini, S Hamada, D Adams and J Fuller
Royal Eye Infirmary, UK
Publication: Eye; Vol. 19
Publication Date: Aug 2005
Technology: Meibomian therapy using latent heat with a novel device
Abstract
This study measures changes in tear film lipid layer thickness (LLT) and ocular comfort
in normal subjects after 10 min use of a novel device, which delivers meibomian therapy
with latent heat. The device is designed to promote the release of meibomian sebum into the
tear film by delivering latent heat to the eyelids, thus thickening the lipid layer. Normal lid
movements are maintained, facilitating resurfacing of the tear film.
Method
A prospective, controlled, observer masked, single intervention trial in which 24 normal
subjects were randomised into three groups. Group I underwent 10 min treatment with the
activated device, Group II used the inactivated device for the same duration of time, and
Group III had no intervention. The LLT of each subject was measured with a Keeler
Tearscope® prior and subsequent to the 10-min period. Subjective alteration in ocular
comfort was also assessed.
Results
Seven of eight subjects (87.5%) in Group I exhibited an increase in LLT. The mean LLT in
this group showed a statistically significant increase (left eyes 1.0 levels, P<0.001, right eyes
0.9 levels, P<0.003) compared to Groups II and III. Six of eight subjects (75%) using the
activated device experienced subjective improvement in ocular comfort.
Conclusion
Meibomian therapy with this device increases LLT in normal individuals. This implies a
more stable tear film, reflected in subjective improvement in ocular comfort.
6
Autologous serum in the treatment of dry eye syndrome. Technological aspects
Herrero-Vanrell R1 and Molina-Martínez
Complutense University.
Publication: Arch Soc Esp Oftalmol, vol 83, Page - 521-524
Publication Year: 2008
Technology: Autologous serum in dry eye treatment.
Description:
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S. No. Bibliographic Details (Journals, White Papers, Conferences)
This journal discuss about Autologous serum in the treatment of dry eye syndrome The
advantages in its use as a treatment for severe dry eye syndrome are based on the fact that
said fluid includes a number of factors which are associated to beneficial effects, particularly
those related to the growth and maintenance of epithelial cells.
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APPENDIX
List of Companies/Universities not discussed33
in this report:
S. No Company
1 Aciex, Inc.
2 Advanced Ocular Systems Limited
3 Agennix Incorporated
4 Altana Pharma Ag
5 Alza Corporation
6 Amedis Pharmaceuticals Limited
7 Amr Technology, Inc.
8 Anthrogenesis Corporation
9 Applied Research Systems Ars Holding
N.V.
10 Archemix Corp.
11 Ardea Biosciences
12 Avicena Group, Inc.
13 Azad Pharma Ag
14 Barnes-Hind Pharmaceuticals, Inc.
15 Bristol-Myers Squibb Company
16 Chakshu Research, Inc.
17 Clarity Corporation
18 Deo Corporation
19 Clear Solutions Biotech, Inc.
20 Combinatorx, Incorporated
21 Compugen Ltd
22 Control Delivery Sys Inc
23 Cytos Pharmaceuticals Llc
24 Dong-A Pharm. Co., Ltd
25 Eco Eye Inc
26 Fuso Pharmaceutical Industries Ltd
27 Galderma Research & Development
33
The list includes companies identified during IP search but not discussed in the report due to minimal number
of patents and published applications, non- availability of product/ product development information.
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S. No Company
29 Genentech, Inc.
30 Gpi Nil Holdings, Inc.
31 Kissei Pharmaceutical Co., Ltd.
32 Laboratoire Medidom S.A.
33 Liposome Technology, Inc.
34 Md Bioalpha Co., Ltd.
35 Yissum Research Development Company
36 Targegen, Inc.
37 Supernus Pharmaceuticals, Inc.
38 Sosei R & D Ltd
39 Sinclair Pharmaceuticals Limited
40 Sigma-Tau Industrie Farmaceutiche Riunite
S.P.A.
41 Melbj Holdings, Llc
42 Menicon Co., Ltd.
43 Milcin Therapeutics Llc
44 Milestone Pharmaceuticals Inc.
45 Molichem Medicines, Inc.
46 Nascent Pharmaceuticals, Inc.
47 Nihon Tenganyaku Kenkyusho Co., Ltd.
48 Nitromed, Inc
49 Novavax
50 Ocular Research Of Boston Inc.
52 Ono Pharmaceutical Co. Lted
53 Ophthalmic Research Associates, Inc.
54 Osmotica Corp.
55 Paratek Pharmaceuticals, Inc.
56 Pericor Science, Inc.
57 Plexxikon, Inc.
58 Predix Pharmaceuticals Ltd.
59 Quark Pharmaceuticals, Inc.
60 Regenerx Biopharmaceuticals, Inc.
61 Revalesio Corporation
62 Rohto Pharmaceutical Co., Ltd.
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S. No University/ Institution
1 The University Of Tennessee Research
Corporation
2 The University Of North Carolina At Chapel
Hill
3 The Johns Hopkins School Of Medicine
4 The Hong Kong Polytechnic University
5 University Of Utah Research Foundation
6 University Of Miami
7 University Of Edinburgh
8 Tufts University
9 Board Of Regents Of The University Of
Nebraska
Search Strategy:
The search was performed in
World Wide Web to identify the relevant manufacturers, products and IP holders in the field
of dry eye treatment.
Delphion to identify key players and their relevant IP assets using optimized search string (see
below highlighted in yellow) that resulted in 1200 hits for US (Issued, Applications), Europe
(Issued, Applications) and PCT applications.
Search Strings
S. No. Search String No. of
Hits
1 (((((("dry eye" or keratoconjuctivitis) and (treat* or cur* or medicin* or plug))))) 4855
2 ((((((dry and eye) or keratoconjuctivitis) and (treat* or cure or medicine)) <in>
(AB,TI,CLAIMS)))) 2081
3 ((((("dry eye" or keratoconjuctivitis) and (treat* or cure or medicine)) <in> (TI, AB,
CLAIMS)))) 1508
4 ((((("dry eye" or keratoconjuctivitis) and (treat* or cur* or medicin* or plug)) <in>
CLAIMS))) 1200
5 ((("dry eye" or keratoconjuctivitis) and (treat*)) <in> CLAIMS) 1181
For Technology Classification
1 (("dry eye" or keratoconjuctivitis) and ((punctal or punctum or plug) <IN> CLAIMS)) 163
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S. No. Search String No. of
Hits
2 (("dry eye" or keratoconjuctivitis) and (("eye drops" or "artificial tears" or "ophthalmic
solution" or "ophthalmic composition") <IN> CLAIMS)) 523
3 ((("dry eye" or keratoconjuctivitis)) AND (((ointment or gel)) <in> CLAIMS) AND NOT
(("artificial tears" or "eye drops"))) 235
4 ((("dry eye" or keratoconjuctivitis)) AND ((("oral composition" or tablet or capsule or oral
)) <in> CLAIMS) AND NOT (("artificial tears" or "eye drops" or plug))) 238
Databases searched: US (granted and applications), Europe (granted and applications), PCT
Keywords: dry eye, keratoconjunctivitis, xerophthalmia, treatment, tears, plugs, medicine, punctal,
punctum, sjogren‟s syndrome, ointment, gels, ophthalmic, artificial tears, eye drops
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