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TABLE OF CONTENTS

6 Innovative Ophthalmic Products and Their Road to FDA Approval By Steven J. Dell, MD

8 The Changing Landscape of the FDA

12 2016 Mergers & Acquisitions

13 2016 FDA Approvals | Drugs

14 2016 FDA Approvals | Ophthalmic Devices

16 Investment and Invention Fuel Ophthalmic Innovation

18 Cataract Surgery Just Became More Efficient

20 Rejuvenating Outflow with a New MIGS Device

22 A New Era in the Surgical Treatment of Refractory Glaucoma

24 The Next Generation of IOL Technology

26 Minimally Invasive Refractive Correction

29 A New Option for Presbyopia

30 Expanding the MIGS Class Facilitates a Greater Ability to Customize Treatment Safety Profile of a Suprachoroidal MIGS Implant: Reviewing Clinical Data

32 A New Approach to Compounded Ophthalmic Therapies

34 MIGS With A New Microcatheter

36 An Outside the Axis Solution to An Age-Old Problem

38 A New Online Resource Advances Patient Education

40 IOL Options For a Full Range of Vision

This special publication highlights some of the newest products that are shaping the future of ophthalmology, as well as information about the industry and the future of the FDA as it relates to eye care.

4 INNOVATIONS IN OPHTHALMOLOGY | 2017

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Iqbal Ike K. Ahmed, MD, FRCSC • Assistant professor and director of the Glaucoma and

Advanced Anterior Surgical Fellowship at the University of Toronto

• ike.ahmed@utoronto.ca

Richard H. Awdeh, MD• Founder of Cirle• (786) 866-2872; richard.awdeh@gmail.com

Brandon D. Ayres, MD• Surgeon in the Cornea Service, Wills Eye Hospital,

Philadelphia• (484) 434-2700; bayers@willseye.org

John Berdahl, MD• Vance Thompson Vision• (605) 361- 3937; john.berdahl@vancethompsonvision.com

Alice Epitropoulos, MD• Ophthalmic Surgeons & Consultants of Ohio• (614)-221-7464; Eyesmd33@gmail.com

Malvina Eydelman, MD• Director of the FDA Center for Devices

and Radiological Health• mbe@cdrh.fda.gov

John F. Doane, MD• Private practice with Discover Vision Centers,

Kansas City, Missouri; clinical assistant professor with the department of ophthalmology, Kansas University Medical Center, Kansas City, Kansas

• (816) 478-1230; jdoane@discovervision.com

Mark J. Gallardo, MD• In private practice at El Paso Eye Surgeons, PA,

in El Paso, Texas• gallardomark@hotmail.com

David Harmon• Market Scope, LLC• (314) 835-0600; daveharmon@market-scope.com

Bonnie An Henderson, MD• Partner in Ophthalmic Consultants of Boston; clinical

professor at Tufts University School of Medicine, Boston• President, American Society of Cataract and Refractive Surgery• (781) 487-2200, ext. 3321; bahenderson@eyeboston.com

James A. Katz, MD• Director, Golf Laser Vision, The Midwest Center for Sight,

Des Plaines, Illinois• (847) 824-3127; jkatz@tmcfs.com

Mahmoud Khaimi, MD• Clinical associate professor at the Dean McGee Eye Institute, University of Oklahoma, Oklahoma City • mahmoud-khaimi@dmei.org

Jeffrey J. Kimbell• Founder and president of Jeffrey J. Kimbell and Associates,

Washington, D.C.• (202) 735-2590; jkimbell@kimbell-associates.com

Gil Kliman, MD• InterWest Partners• (650) 854-8585; Gliman@interwest.com Michael Lachman• EyeQ Research• (925) 939-3899; Michael@lachmanconsulting.com

Richard A. Lewis, MD• Private practice in Sacramento, California. • (916) 649-1515; rlewiseyemd.yahoo.com

Andrew S. Morgenstern, OD, FAAO • Chief Medical Editor, Advanced Ocular Care and

EyeTubeOD.com• Vision Center of Excellence, Walter Reed National Military

Medical Center, Bethesda, Md.; President, Optometric Cornea, Cataract and Refractive Society

• @iEyeDoc; andrewmorgenstern@gmail.com

Robert Pollock• Former acting deputy director of the FDA’s Office of

Generic Drugs• R.Pollock@LahmanConsultants.com

Michael X. Repka, MD• Medical director of government affairs for the American

Academy of Ophthalmology• mdaigle@aaodc.org

Arsham Sheybani, MD• Assistant professor, Washington University School of

Medicine, department of ophthalmology and visual science, St. Louis, Missouri

• (314) 362-3937; sheybaniar@wustl.edu

CONT

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Stephen G. Slade, MD• Cofounder, Slade and Baker Vision, Houston• (713) 626-5544; sgs@visiontexas.com

Karl G. Stonecipher, MD• Director of Refractive Surgery, The Laser Center,

Greensboro, North Carolina• stonenc@aol.com

Andrea P. Thau, OD• President of the American Optometric Association• SLThomas@aoa.org

Vance Thompson, MD• Founder, Vance Thompson Vision • (605) 361-3937; vancethompson@vancethompsonvision.com

Carl Tubbs, MD• Practicing ophthalmologist, InSight Vision Group, Denver• C2K2TUBBS@msn.com

Steven D. Vold, MD• In private practice at Vold Vision in Fayetteville, Arkansas• Chief Medical Editor, Glaucoma Today• (479) 442-8653; svold@voldvision.com

Scott Whitaker• President and CEO of the trade group Advanced Medical

Technology Association• JDobson@advamed.org

Lawrence Woodard, MD• Board-certified ophthalmologist and medical director

of Omni Eye Services of Atlanta• lwoodard@omnieyeatlanta.com

Elizabeth L. Yeu, MD• Partner at the Virginia Eye Consultants, Norfolk,

Virginia• Assistant professor, department of ophthalmology,

Eastern Virginia Medical School, Norfolk, Virginia• eyeulin@gmail.com; Twitter @LizYeu

BUSINESSDAVID COX, President/Cofounder(484) 581-1814; dcox@bmctoday.com

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BRYAN BECHTEL, Contributing Editor

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ART/Production JOE BENINCASA, Digital Art Director(484) 581-1822; jbenincasa@bmctoday.com

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