Ocular Disorders-Insight Pharma Reports

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INSIGHT PHARMA REPORTS 250 First Avenue Suite 300 n Needham, MA 02494 n 781.972.5444 n InsightPharmaReports.comA Division of Cambridge Healthtech Institute

Ocular Disorders:Rising Therapeutics, Technologies, and Devices

Available to Insight Pharma Reports is Ocular Disorders: Rising Therapeutics, Technologies, and Devices Report. This report begins with outlining Age-related macular degeneration (both wet and dry) and delving into Anti-VEGF therapies in chapter 2. Further providing substantial weight to this report, several companies were interviewed on their approach to targeting wet and dry AMD, their strategies for seeking

alternative therapeutic options, and the hardships they have encountered in their research and product execution.

Report highlights include:• Exclusive interviews from four companies (Oraya Therapeutics,

VisionCare Ophthalmic Technologies, Omeros, and Kala Pharmaceuticals) providing details of their products.

• Both invasive and noninvasive procedures are discussed, along with current treatment options and how they relate to rising therapies.

• Demographic survey and analysis of researchers working in ocular disorders including promising therapeutic options, targets of interest, and challenges encountered.

• Over 250 companies featuring clinical trials and pipeline data. • Over 200 company and institution profiles included

http://www.insightpharmareports.com

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Executive Summary

O cular Disorders: Rising Therapeutics, Technologies, and Devices covers a handful of companies and their approach to targeting ocular diseases, particularly wet and dry age-related macular degeneration (AMD). This report provides a sample of therapies on the rise for various ocular complications.

The standard therapy for wet-AMD is anti-VEGF injections. The benefit to these injections is that they hinder the progression of wet-AMD. The challenge is that patients usually have to receive frequent injections to maintain the therapeutic benefit. Additionally, they don’t reverse or stop the progression of damage to the eye, so this also poses a problem for patients who have had the disease long-term. Currently, there is no treatment for dry-AMD.

In an interview with several companies including Oraya Therapeutics, VisionCare, Omeros, and Kala Pharmaceuticals, representatives mentioned several technologies and devices in development for the treatment of ocular disorders, primarily wet-AMD, and some for even dry-AMD. Their approaches to these therapies also differ from one another and include: radiation therapy, implantable telescope technology, PharmacoSurgery, and mucosal penetrating products.

Speaking to AMD, Oraya Therapeutics is utilizing radiotherapy with a multi-unit system designed to carefully, and noninvasively, deliver X-rays to treat the macula for sub-foveal choroidal neovascularization due to AMD. As for a more invasive procedure, VisionCare provides an implantable telescope in to the back of the eye; it is the only surgical option that improves visual acuity by reducing the impact of the central vision blind spot caused by end-stage AMD.

Combing both therapeutics and surgical procedures, Omeros is utilizing PharmacoSurgery, which is a multimodal and targeted approach to preemptively control the common problems induced by surgical and medical procedures. Complementing this procedure is Omeros’s deep pipeline of therapeutic agents targeting ocular inflammation. Other products for inflammation are provided by Kala Pharmaceuticals, which has two targets in clinical trials and one that is expected to enter clinical trials in 2014. In addition to inflammation, their treatment candidates also focus on blepharitis and dry eye.

Also included in this report is a demographic survey of researchers working in ocular disorders. Some of the concepts include disorders with promising therapeutic options, expected therapeutic options, most promising targets, and challenges encountered.


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Table of ContentsExecutive Summary

CHAPTER 1

Age-Related Macular DegenerationWet AMDDry AMD

CHAPTER 2

Therapeutic EfficacyAnti-VEGF therapiesPegaptanib

Bevacizumab

Ranibizumab

VEGF Trap-EYE

CHAPTER 3

Oraya TherapeuticsRadiotherapy platformAutomatic Positioning System (APS)

I-Guide System software

Radiation dosingPotential complications and risk factorsCompetitive advantageChallenges and areas of improvementFuture expectationsInterview with Jim Taylor Radiation therapyjCompetitive advantage

Challenges encountered

Areas of improvement

Future expectations

CHAPTER 4

VisionCare Ophthalmic TechnologiesCompany backgroundTelescope technologyComplications and challengesInterview with Reena MishraCompany background

Telescope technology

Competitive advantage

Complications and challenges

CHAPTER 5

Omeros Company backgroundPharmacoSurgery platformPipelineCompetitive advantageChallenges encounteredValidationFuture expectationsInterview with Greg DemopulosCompany background

PharmacoSurgery platform

OMS302



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Validation procedure Future expectations

CHAPTER 6

Kala PharmaceuticalsCompany backgroundMucosal penetrating products (MPP)Competitive advantageFuture endeavorsInterview with Kim BrazzellCompany background

Mucosal penetrating products (MPP)



Future endeavors

CHAPTER 7

Platforms and Products

CHAPTER 8

Survey of Ocular IndustryAreas of developmentPromising targets and therapiesChallenges encountered

CHAPTER 9

Clinical Trials and Pipeline Data

CHAPTER 10

Company Profiles13therapeutics, Inc.2C Tech Corporation, Inc.AbbVie Inc.Abdi Ìbrahim Ìlac Sanayi ve Tic A.S. (Abdi Ibrahim)AC Immune SAACADIA PharmaceuticalsAciex Therapeutics, Inc.Aciont Inc.Acorn Biomedical, Inc.Actavis hf.Acucela Inc.Adamed Sp. z o.o.Adenovir Pharma ABAdeTherapeutics Inc.Aerie Pharmaceuticals, Inc.Aerpio Therapeutics, Inc.Akebia Therapeutics, Inc.Akorn Pharmaceuticals, Inc.Alcon Laboratories, Inc.Alexion Pharmaceuticals, Inc. Translational Medicine Center Alimera Sciences, Inc.Alkeus Pharmaceuticals, Inc.Allegro Ophthalmics LLCAllergan, Inc.Allergan S.A.U.Altacor Altheos, Inc.Amakem Therapeutics NVAmorChem L.P.


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AngioLab, Inc.Ångstrom Pharmaceuticals, Inc.Apellis Pharmaceuticals, Inc.Apitope International NVApplied Genetic Technologies Corp. (AGTC)ArcticDx, Inc.Argos Therapeutics, Inc.AriBioAscendis Pharma A/SAsclepiX Therapeutics, LLCAsklepios BioPharmaceutical, Inc.Aspireo Pharmaceuticals LimitedAus Bio LimitedAuven Therapeutics Management L.L.L.P. Avalanche Biotechnologies, Inc.AvedroAxxam S.p.A.Bach Pharma, Inc.Bausch & LombBausch & Lomb Canada Inc.Bayer Yakuhin, Ltd.BCN Peptides S.A.Beijing Northland Biotech Co., Ltd.Beijing Tide Pharmaceutical Co., Ltd.Benitec Biopharma Ltd.Betastem Therapeutics, Inc.Bicycle Therapeutics LimitedBinex Co., Ltd.Biocodex S.A.BiocyciveBioDiem Ltd

Bioftalmik BioMotiv LLCBionureBiophytis Bloomage BioTechnology Corporation LimitedBluBio (Yantai) Biopharmaceutical Co., Ltd.Bohus BioTech ABBoston Children’s Hospital Brill PharmaCalista Therapeutics, Inc.Can-Fite BioPharma Ltd.Catalyst BiosciencesCell Cure Neurosciences LtdCellSeed Inc.Celsus Therapeutics plcCeltaxsys, Inc.Charlesson LLCChia Tai Tianquing Pharmaceutical Group Co., LtdChina Resources Zizhu Pharmaceutical Co., Ltd Circadian Technologies LimitedClayton Biotechnologies, Inc.Clearside Biomedical, Inc.Compugen Ltd.Corena Therapeutics SARLD.Western Therapeutics Institute, Inc.Dalian Innobioactives Co., Ltd.Diaxonhit TherapeuticsDIOPTIC Laboratories, Inc.DNAVEC CorporationDompé s.p.a.Dong-A ST


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Eleven Biotherapeutics, Inc.Eli Lilly and CompanyEmcure Pharmaceuticals Ltd.Encore Vision, Inc.Envisia Therapeutics™, Inc. Enzo Biochem, Inc.Eos Neuroscience, Inc.EryDel S.p.A.ESBATech, a Novartis companyEssex Bio-Technology LimitedEsteveEupraxia Pharmaceuticals Inc.Europharm Laboratoires Co. Ltd.Evonik CorporationExonateEyeGate Pharmaceuticals, Inc.EyeGene, Inc.EyeTechCare SAEye Therapies LLCEyevensys SAF. Hoffmann-La Roche AGFarmaprojects S.A.U.Farmigea S.p.A.FirstString Research, Inc.Foamix Pharmaceuticals Ltd.Fondazione TelethonForSight Labs, LLC ForSight VISION5, Inc.Freedom Meditech, Inc.La Fundación General de la Universidad de Valladolid FGUVaGalecto Biotech AB

Genable Technologies Ltd.Genentech, Inc.Gene Signal International SAGenSight BiologicsGenzyme® CorporationGlaxoSmithKline plcGrayBug® LLCGriffin Discoveries BVG-treeBNT Co., Ltd.HanAll BioPharma Co. Ltd.Hanlim Pharmaceuticals Inc.Harmonic PharmaHealios KKHemera Biosciences, Inc.Herantis Pharma plc High Point Pharmaceuticals, LLC (formerly TransTech Pharma, Inc.)Horus PharmaHubei Kangzheng Pharmaceutical Co., Ltd.Hyundai Pharm. Ind. Co., Ltd.iCo Therapeutics Inc.Iconic Therapeutics, Inc.Ilsung Pharmaceuticals Co. Ltd.Imagen Biotech, Inc.Immco Diagnostics, Inc.Immunservice GmbHImplandata Ophthalmic Products GmbHImprimis Pharmaceuticals, Inc.Inflamalps SAInFlectis BioScienceInnoCore Technologies BVInnoPharma, Inc.


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Innovent Biologics, Inc.Inotek Pharmaceuticals CorporationInSite Vision IncorporatedIntellect Neurosciences, Inc.InteRNA Technologies B.V.International Stem Cell CorporationIntrexon Corporationipal GmbHIsis Pharmaceuticals, Inc.iSTAR Medical SAJade Therapeutics, Inc.Jiangsu Farever Pharmaceutical Co., Ltd.Jiangsu T-mab BioPharmaKala Pharmaceuticals, Inc.KalVista Pharmaceuticals Ltd.Kangmei Pharmaceutical Co., Ltd. Korea Research Institute of Chemical TechnologyKowa Company, Ltd.Kunshan RiboQuark Pharmaceutical Technology Co. Ltd.Kytogenics Pharmaceuticals, Inc.Laboratoires GenévrierLaboratoires ThéaLaboratorios SALVAT S.A.Laboratorios Sophia S.A. de C.V.Lacerta Bio Inc.LambdaVision, Inc.Lee’s Pharmaceutical Holdings Ltd.Lexicon Pharmaceuticals, Inc.Livwel Therapeutics, Inc.Lotus Innovative Health, Ltd.Lpath Incorporated

MacuCLEAR, Inc.MacuLogix, Inc.Mati Therapeutics, Inc.Merck Serono (EMD Serono)Mesoblast LimitedMeta-IQMimetogen Pharmaceuticals, Inc.Mitsubishi Tanabe Pharma CorporationMolecular Partners AGMontefarmaco OTC S.p.A.Moorfields PharmaceuticalsMystic PharmaceuticalsMyungmoon Pharm. Co., Ltd.NanomericsNano Retina, Inc.NanoVector srlNanoViricides, Inc.Nektar TherapeuticsNEMUS Bioscience, Inc.Neothetics™, Inc.Neuroptis BiotechNeuroscienze PharmaNess S.c.a.r.L.Neurotech Pharmaceuticals, Inc.Nexus Pharamaceuticals, Inc.NicOx Research Institute SRLNicOx S.A. NightstaRx Ltd.NovaBay Pharmaceuticals, Inc.Novaliq GmbHNovaMedica LLCNovartis International AG


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Novartis Ophthalmics AGNovelMed Therapeutics, Inc.Ocata Therapeutics, Inc. Ocugen, Inc.OculeveOculis ehfOgenx Therapeutics Corporation, Inc.Ohr Pharmaceutical Inc.Omeros CorporationOMIDA AGONL Therapeutics LLCOphthaliX, Inc.OphthalmoPharma Ltd. Ophthotech Corp.Opocrin S.p.A.Opthea Pty LtdOra Bio Ltd.Oraya Therapeutics, Inc.Otsuka Pharmaceutical Europe LtdOxford BioMedica plcOxiGENE, Inc.Palobiofarma S.LPanoptes Pharma GmbHPanOptica, Inc.Parion SciencesPDL BioPharma, Inc.Perrigo Company plcPfenex Inc.PfizerPharma Two B Ltd.Physica Pharma

Pieris Pharmaceuticals, Inc.Pierre Fabre SAPIQUR Therapeutics AGPixium Vision SAPolyActiva Pty Ltd.Potentia Pharmaceuticals, Inc.Present Value LtdPromedior, Inc.ProRetina Therapeutics, S.L. Provectus Biopharmaceuticals, Inc.pSivida Corp.QLT IncQuark Pharmaceuticals, Inc.Rapid Pathogen Screening, Inc.Reata Pharmaceuticals, Inc.Regeneron Pharmaceuticals RegeneRx Biopharmaceuticals, Inc.REGENXBIO Inc.ReNeuron Group plcResolvyx Pharmaceuticals, Inc.RestorGenex CorporationRetroSense Therapeutics LLCRigel Pharmaceuticals, Inc.River Vision Development Corp.Roche Diagnostics GmbHRoche SASR-Tech Ueno, Ltd.RXi Pharmaceuticals CorporationSam Chun Dang Pharm. Co., LtdSamil Pharm. Co., Ltd.SanBio, Inc.


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Sanitas ABSanofi S.A.Santen Pharmaceutical Co., Ltd.Santhera PharmaceuticalsSATT LutechSCYNEXIS, Inc.Senju Pharmaceutical Co., LtdShire plc SIFI SpASilvanolsSirnaomics, Inc.SK BiopharmaceuticalsSolx, Inc.Spark Therapeutics, Inc.Specialised Therapeutics Australia Pty LtdStarpharmaStealth Peptides International (Shanghai) Inc.Stelic Institute & Co., Inc.Stelis Biopharma Pvt. Ltd.StemCells, Inc.Strathclyde University, Health TechnologiesStreuli Pharma AGStrides Arcolab Ltd.Sucampo Pharmaceuticals, Inc.Sun Pharma Advanced Research Company (SPARC) Ltd.Suzhou Sirnaomics Biopharmaceuticals Co. Ltd.Sylentis S.A.SynCore Biotechnology Co., LtdSynovo GmbHTacere Therapeutics, Inc.

Tactical Therapeutics, Inc.Taejoon Pharm Co., Ltd.Taiwan Liposome Company Ltd.TearScience®, Inc.Teijin Pharma LimitedThromboGenics NVTLC Biopharmaceuticals B.V.TOA EIYO LTD.TopiVert Ltd.TRACON Pharmaceuticals, Inc.TRB Chemedica International S.A.TxCellUNIMED PHARMA, spol. s r.o.UNITHER Pharmaceuticals University of NottinghamUniversity of Santiago de CompostelaValeant Pharmaceuticals International, Inc.Valentia Biopharma S.L.Venture Life LtdVibalogics GmbHVisionCare Ophthalmic Technologies. Inc.VISIOTACT PharmaWellstat Ophthalmics CorporationX-BODY Biosciences, Inc.Xcovery VisionXediton Pharmaceuticals Inc.XOMA CorporationYoucare Pharmaceutical Group Co., Ltd.ZeaVision®, LLCZiarco


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ReferencesAbout Cambridge Healthtech Institute

TABLESTable 2.1: Clinical status for common therapies for wet AMD

Table 3.1 Platform specifications

Table 4.1: Platform specifications

Table 5.1: Targets and their clinical status

Figure 6.1: Targets and Their Clinical Status

Table 7.1: Targets in Clinical Stages

Table 7.2: Therapeutic Platforms Specifications

FIGURES

Figure 8.1: Areas of research

Figure 8.2: Ocular disorders of interest

Figure 8.3: Promising therapies for ocular diseases

Figure 8.4: Promising targets for ocular therapies

Figure 8.5: Challenges encountered


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Survey of Ocular Industry Ocular Disorders: Rising Therapeutics, Technologies, and Devices

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CHAPTER 8

Survey of Ocular Industry

I n addition to gathering information from a handful of companies in this space, Insight Pharma Reports also surveyed the general population of researchers working in the ocular space to provide even more perspective in this growing field. The results cover a

range of information including specific areas of development, promising targets and therapeutics, and challenges encountered. These results are discussed below and highlighted with various charts and graphics.

Areas of development

To gain an understanding of the research taking place in this field, Insight Pharma Reports (IPR) inquired about the area of ocular disorders people were working in, and the results are spread out across the board. According to Figure 8.1, 35% of respondents are working in therapeutic development, 17% in drug discovery, 13% in medical devices and 13% in assay development. The 22% that responded “other” were asked to specify their answers, which included: clinical development, research, trials; therapeutic efficiency; molecular pathways and genetic causes; pathophysiology of ocular disorders; ocular infectious disease treatment modalities; bioinformatics; drug delivery; preclinical research; communication; and legal issues. Ocular therapeutics are being studied in a variety of ways, creating room for little competition, discovering of multiple therapeutics, and developing improved assays and medical devices.

Additionally, IPR also gathered information on which ocular disorders researchers thought were most promising to pursue therapeutics for. Figure 8.2 shows a variety of disorders, and 40% of researchers see wet AMD as the most promising for therapeutic options. After that is glaucoma (32%), diabetic macular edema (25%) and dry AMD and allergic conjunctivitis, both with 19%. Based on the amount of interest in alternative treatments for wet AMD in the report information above, it isn’t surprising to see this as having the most promising therapeutic options. These results support the amount of investment being made in wet AMD including the use of medical devices and alternative therapies.

Figure 8.1: Areas of researchWhich area best describes your line of work?Figure 8.1: Areas of Research

Source: Insight Pharma Reports

Drug discovery 17%

Therapeutic development 35%

Assay development 13%

Medical device development 13%

Other 22%

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Clinical Trials and Pipeline Data Ocular Disorders: Rising Therapeutics, Technologies, and Devices

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CHAPTER 9



Company Product Country Developmental Phase Therapeutic Area

13therapeutics P13 for Uveitis USA Preclinical Uveitis

AbbVie Inc. HUMIRA (adalimumab) USA Phase III Uveitis

Abdi Ìbrahim Ìlac Sanayi ve Tic A.S.

Cortimycine Eye Ointment Turkey On the Market n/a

Sikloplejin Eye Drops Turkey On the Market n/a

AC Immune SA ACI-260 (Abeta inhibitor Glaucoma) Switzerland Preclinical Glaucoma

ACADIA Pharmaceuticals AB Muscarinic Agonist Sweden Phase I Glaucoma

ACADIA Pharmaceuticals Inc. Muscarinic Agonist for glaucoma USA Phase I Glaucoma

Aciont Inc.

Investigative drug for chronic uveitis USA Preclinical n/a

Investigative drug for diabetic macular edema (first line) USA Lead optimization Diabetic related eye disorder

Investigative drug for dry or wet AMD USA Lead optimization n/a

Steroid for diabetic macular edema (adjuvant therapy) USA Preclinical Diabetic related eye disorder

Steroid for severe uveitis USA Preclinical Uveitis

Acorn Biomedical, Inc ACN-1052 USA Preclinical Glaucoma

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Clinical Trials and Pipeline Data Ocular Disorders: Rising Therapeutics, Technologies, and Devices

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Company Product Country Developmental Phase Therapeutic Area

Actavis hf. Artelac Iceland On the Market n/a

Acucela Inc.

OPA-6566 USA Phase I Glaucoma

Other VCM and retinal product candidates USA Preclinical n/a

VCM - Emixustat HCI for AMD USA Phase III Macular degeneration

VCM - Emixustat HCI for Diabetic Retinopathy (DR)/Diabetic Macular Edema (DME) USA Preclinical Diabetic related eye disorder

VCM - Emixustat HCI for Stargardt, Retinitis Pigmentosa, Retinopathy of Prematurity USA Preclinical n/a

Adamed Sp. z o.o. Rozacom (Dorzolamidum, Timololum) Poland On the Market n/a

Adenovir Pharma AB APD -209 Sweden Phase I n/a

AdeTherapeutics inc Ophthalmology Canada Preclinical Glaucoma

Advanced Cell Technology, Inc.

MSC Program USA Preclinical n/a

Ocular programs USA Preclinical n/a

RPE (retinal pigment epithelial) program USA Phase I Macular degeneration

RPE (retinal pigment epithelial) program for Dry AMD USA Phase I n/a

Aerie Pharmaceuticals, Inc.

AR-13533 USA Preclinical n/a

Rhopressa Triple-action - ROCK/NET inhibition USA Phase III n/a

Roclatan USA Phase II n/a

Aerpio Therapeutics, Inc.

AKB-9778 USA Phase II Macular degeneration

HPTPBeta MAb USA Preclinical Diabetic related eye disorder

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Company Profiles Ocular Disorders: Rising Therapeutics, Technologies, and Devices

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CHAPTER 10

Company Profiles13therapeutics, Inc.

13therapeutics, Inc is a privately held research and drug development company identifying, characterizing, and optimizing novel anti-inflammatory peptide therapeutics for unmet medical needs with high commercial potential. The company has an innovative platform for discovering and enhancing peptides, derived from naturally occurring pathogens (e.g., bacteria, viruses, fungi) which modulate the human immune response. This platform has produced a portfolio of patented novel anti-inflammatory peptides with demonstrated immune-regulatory activity and with varying mechanisms of action. The peptides have applications for treatment of a variety of inflammatory diseases, including uveitis. Peptide 13 is the company’s most extensively characterized peptide and is being developed as a treatment for hearing loss in patients with otitis media and in individuals exposed to excessive noise. Based in Portland, Oregon, 13therapeutics was founded in 2008. The company is a spin-out of the Oregon Health and Science University.

2C Tech Corporation, Inc.

2C Tech Corporation, Inc., an Irvine, California-based biotech company, is the developer of the patent-pending SeeQ intraocular medical device, which delivers photoactive nanoparticles that convert light to electrical energy, similar to a conventional solar cell but on a sub-cellular scale. The SeeQ device is designed to addresses the unmet need of the millions of patients who suffer from retinal degenerative diseases, such as retinitis pigmentosa, diabetic retinopathy, and macular degeneration, which ultimately lead to blindness. SeeQ consists of a large number of proprietary nanoparticles in a colloidal solution. Each particle contains a charge generator and a guidance biomolecule. The SeeQ is injected into the vitreous, where the biomolecules guide the SeeQ nanoparticles to photoreceptor cells. The nanoparticles convert ambient light entering the eye into electrical energy, which stimulates and preserves the photoreceptors cells. 2CTech was founded in 2008.

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AbbVie Inc.

AbbVie Inc. is a global, research-based biopharmaceutical company formed in 2013 following its separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people, and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. Its products include HUMIRA® (adalimumab), which is approved for use in moderate to severe rheumatoid arthritis, active juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy, ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn’s Disease, and moderate to severely active ulcerative colitis. HUMIRA is also in Phase III development for the treatment of uveitis. AbbVie is headquartered in North Chicago, Illinois.

Abdi Ìbrahim Ìlac Sanayi ve Tic A.S. (Abdi Ibrahim)

Abdi İbrahim is Turkey’s leading pharmaceutical company, employing 2,700 people, boasting an extensive sales network, and offering a portfolio of 160 brands which are exported to more than 30 countries around the world. Products currently on the market include Cortimycine Eye Ointment and Sikloplejin Eye Drops. The company’s R&D facility is Turkey’s largest accredited R&D center in the pharmaceutical sector. On the occasion of its 100th anniversary, Abdi Ibrahim launched its “Rational Use of Medicines Campaign” to create social awareness about the irresponsible use of medications. The company was founded in 1912 and is based in Istanbul, Turkey.

AC Immune SA

AC Immune SA is a biopharmaceutical company that designs, discovers, and develops therapeutic and diagnostic products to prevent and modify diseases caused by misfolding proteins. Its two proprietary technology platforms create antibodies, small molecules, and vaccines to address large markets across a broad spectrum of central nervous system indications. Alzheimer’s disease (AD) is the largest indication addressed by its products, but the company’s innovative, highly differentiated, and disease-modifying therapies are capable of shifting the paradigm in the treatment of other neurodegenerative diseases such as Down syndrome, Parkinson’s, tauopathies, glaucoma, and Huntington’s. AC Immune has a large, diversified, and promising pipeline featuring seven therapeutic and two diagnostic products in AD. The company’s product pipeline also includes ACI-260 (Abeta inhibitor Glaucoma), which is in preclinical development. Founded in 2003, AC Immune is headquartered in Lausanne, Switzerland.

ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in neurological and related central nervous system disorders. The firm has a pipeline of product candidates led by NUPLAZID (pimavanserin), for which it has reported positive Phase III trial results in Parkinson’s disease psychosis and which has the potential to be the first drug approved in the United States for this disorder. Pimavanserin is also in Phase II development for Alzheimer’s disease psychosis and has successfully completed a Phase II trial in schizophrenia. Additionally, ACADIA has clinical-stage programs for

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chronic pain and glaucoma in collaboration with Allergan, Inc. The two companies’ muscarinic agonist partner program involves developing small-molecule product candidates for the treatment of glaucoma. Using ACADIA’s proprietary discovery platform, researchers identified a subtype of the muscarinic receptors that controls intraocular pressure and discovered lead compounds that selectively activate this target. In preclinical models, product candidates have demonstrated a promising preclinical profile, including robust efficacy and a long duration of action. The program has reached Phase I development. ACADIA was founded in 1993 and is based in San Diego, California.

Aciex Therapeutics, Inc.

Aciex Therapeutics, Inc. established in 2007 and based in Westborough, Massachusetts, is an ophthalmic pharmaceutical company focused on developing first-in-class products to treat ocular diseases. It offers products to treat dry eye, aesthetic ocular conditions, infectious diseases, allergic conjunctivitis, inflammation, ocular pain, glaucoma, and retinal degenerative diseases. Aciex’s product pipeline, which includes both clinical stage and pre-IND assets, is designed to fill significant unmet therapeutic needs and allow the company to build a sustainable ophthalmic franchise. Pipeline compounds include AC-170 for allergic conjunctivitis and AC-155 for post-operative ocular inflammation and pain. The firm was founded with technology licensed from Afferent Therapeutics LLC, a spin-out from Ora, Inc. As of October 2014, Aciex operates as a subsidiary of Nicox SA, an emerging international company that is headquartered in Sophia Antipolis, France and is focused on the ophthalmic market.

Aciont Inc.

Aciont Inc. is a specialty biopharmaceutical company that addresses a substantial void in ocular therapeutics. Most commercial therapies for back-of-the-eye diseases are administered through repeated injections into the eye. There are currently no commercialized applications entailing a localized, non-invasive system that can deliver drugs to the back of the eye. Aciont’s proprietary Visulex® drug delivery system uses an easy-to-administer sclera lens-shaped eye applicator worn for less than 10 minutes. The revolutionary platform incorporates novel sustained-release formulations or methodologies for water-soluble drugs as part of a non-invasive drug delivery system. The passive, diffusion-based version of the Visulex system has been shown to deliver therapeutically relevant drug doses of a steroid pro-drug into interior sections of the eye. Aciont is also developing a pipeline of drug candidates that can be administered via the Visulex system. Candidates include steroids for severe uveitis and diabetic macular edema as well as investigative drugs for chronic uveitis, diabetic macular edema, and dry or wet age-related macular degeneration. Aciont was founded in 2000 and is located in Salt Lake City, Utah.

Acorn Biomedical, Inc.

Based in Palo Alto, California, Acorn Biomedical, Inc. is a development stage biopharmaceutical company focused on innovative drug therapies. It develops first-in-class compounds targeting the Adenosine A3 receptor (A3AR), which modulates the production of aqueous humor in the eye. A3AR antagonists are a novel treatment for glaucoma. The company’s lead candidate, ACN-1052, is the first orally bioavailable, potent, selective, and specific A3AR antagonist with single-digit nM

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Ocular Disorders-Insight Pharma Reports

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