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INNOVATIONS IN OPHTHALMOLOGY | 2017 3
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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
Richard H. Awdeh, MD• Founder of Cirle• (786) 866-2872; [email protected]
Brandon D. Ayres, MD• Surgeon in the Cornea Service, Wills Eye Hospital,
Philadelphia• (484) 434-2700; [email protected]
John Berdahl, MD• Vance Thompson Vision• (605) 361- 3937; [email protected]
Alice Epitropoulos, MD• Ophthalmic Surgeons & Consultants of Ohio• (614)-221-7464; [email protected]
Malvina Eydelman, MD• Director of the FDA Center for Devices
and Radiological Health• [email protected]
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; [email protected]
Mark J. Gallardo, MD• In private practice at El Paso Eye Surgeons, PA,
in El Paso, Texas• [email protected]
David Harmon• Market Scope, LLC• (314) 835-0600; [email protected]
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; [email protected]
James A. Katz, MD• Director, Golf Laser Vision, The Midwest Center for Sight,
Des Plaines, Illinois• (847) 824-3127; [email protected]
Mahmoud Khaimi, MD• Clinical associate professor at the Dean McGee Eye Institute, University of Oklahoma, Oklahoma City • [email protected]
Jeffrey J. Kimbell• Founder and president of Jeffrey J. Kimbell and Associates,
Washington, D.C.• (202) 735-2590; [email protected]
Gil Kliman, MD• InterWest Partners• (650) 854-8585; [email protected] Michael Lachman• EyeQ Research• (925) 939-3899; [email protected]
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; [email protected]
Robert Pollock• Former acting deputy director of the FDA’s Office of
Generic Drugs• [email protected]
Michael X. Repka, MD• Medical director of government affairs for the American
Academy of Ophthalmology• [email protected]
Arsham Sheybani, MD• Assistant professor, Washington University School of
Medicine, department of ophthalmology and visual science, St. Louis, Missouri
• (314) 362-3937; [email protected]
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INNOVATIONS IN OPHTHALMOLOGY | 2017 5
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Stephen G. Slade, MD• Cofounder, Slade and Baker Vision, Houston• (713) 626-5544; [email protected]
Karl G. Stonecipher, MD• Director of Refractive Surgery, The Laser Center,
Greensboro, North Carolina• [email protected]
Andrea P. Thau, OD• President of the American Optometric Association• [email protected]
Vance Thompson, MD• Founder, Vance Thompson Vision • (605) 361-3937; [email protected]
Carl Tubbs, MD• Practicing ophthalmologist, InSight Vision Group, Denver• [email protected]
Steven D. Vold, MD• In private practice at Vold Vision in Fayetteville, Arkansas• Chief Medical Editor, Glaucoma Today• (479) 442-8653; [email protected]
Scott Whitaker• President and CEO of the trade group Advanced Medical
Technology Association• [email protected]
Lawrence Woodard, MD• Board-certified ophthalmologist and medical director
of Omni Eye Services of Atlanta• [email protected]
Elizabeth L. Yeu, MD• Partner at the Virginia Eye Consultants, Norfolk,
Virginia• Assistant professor, department of ophthalmology,
Eastern Virginia Medical School, Norfolk, Virginia• [email protected]; Twitter @LizYeu
BUSINESSDAVID COX, President/Cofounder(484) 581-1814; [email protected]
ADAM KRAFCZEK JR, ESQ, Vice President/Cofounder(484) 581-1815; [email protected]
TAMARA BOGETTI, MBA, Executive Vice President/Group Publisher(714) 878-0568; [email protected]
GAYNOR MORRISON, Vice President, Sales(484) 581-1836; [email protected]
SARAH AEMISEGGER, Account Manager(484) 581-1878; [email protected]
JANET BURK, Account Manager(214) 394-3551; [email protected]
ALLISON DABNEY, Account Manager(404) 998-3974; [email protected]
BARBARA BANDOMIR, Vice President, Operations(484) 581-1810; [email protected]
DAVID LEVINE, Executive Vice President, Digital & Custom Media(609) 933-6799; [email protected]
LAURA O’CONNOR, Digital Technologies Director(484) 581-1860; [email protected]
MEGAN BEISSER, Senior Director, Digital Products and Programs(484) 581-1862; [email protected]
GENEVIEVE MOSER, Director of Analytics and Audience Development(484) 581-1858; [email protected]
EMILY FEINMAN, Circulation Manager/Sales Assistant(484) 581-1835; [email protected]
EDITORIALCASSANDRA A. RICHARDS, Special Projects Director(484) 581-1883; [email protected]
STEPHEN DAILY, Executive Editor, News(484) 581-1871; [email protected]
DANIEL YOUNG, Digital Engagement Editor(484) 581-1875; [email protected]
BRYAN BECHTEL, Contributing Editor
JOSEPH CANTLUPE, Contributing Editor
ROCHELLE NATALONI, Contributing Editor
VIRGINIA PICKLES, Contributing Editor
ADRIANNE RESEK, Contributing Editor
ART/Production JOE BENINCASA, Digital Art Director(484) 581-1822; [email protected]
JOHN FOLLO, Creative/Production Director(484) 581-1811; [email protected]
DOMINIC CONDO, Art Director(484) 581-1834; [email protected]
RACHEL GREENE, Graphic Designer(484) 581-1853; [email protected]
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I N N O V A T I O N S