Jul 4 2013
The American Academy of Ophthalmology today announced that it is joining forces with the U.S. Food and Drug Administration (FDA) in an effort to improve the regulatory science around the approval of premium medical devices that can significantly benefit cataract patients.
IOLs are used in cataract surgery, the most common elective surgery in the U.S., and implanted in over three million American cataract surgery patients a year.
The organizations are jointly conducting a workshop at the FDA headquarters on October 11, which will bring together clinicians, academicians, federal employees and industry experts to discuss challenges to intraocular lens (IOL) innovation with a focus on endpoint methodologies used in evaluating IOL safety and effectiveness.
IOLs are used in cataract surgery, the most common elective surgery in the U.S., and implanted in over three million American cataract surgery patients a year. Over the past two decades, IOLs have undergone significant design changes allowing them to correct for a spectrum of visual distances, and therefore have evolved from traditional (monofocal) IOLs to premium (multifocal or accommodating) IOLs. While IOL technology has quickly evolved, some endpoints for the evaluation of these novel features also require evolution. The goal of the workshop is to increase the efficiency in which IOLs get to the U.S. market.
"If a wider variety of premium IOLs were made available in the U.S., this could help improve quality of life for cataract patients," said Paul Sternberg Jr., M.D., president of the American Academy of Ophthalmology. "The Academy looks forward to working with the FDA, along with physician and medical-device industry thought leaders, to ensure a more timely delivery of these devices to the American people."
The workshop will be opened by Dr. Sternberg; Jeffrey E. Shuren, M.D., J.D., director of the FDA Center for Devices and Radiological Health, and Malvina Eydelman, MD, director of the FDA Division of Ophthalmic and Ear, Nose and Throat Devices. It will be moderated by Academy Trustee-at-Large Thomas Oetting, MD, professor of clinical ophthalmology at the University of Iowa College of Medicine, and Academy member Malik Y. Kahook, MD, professor of Ophthalmology and the Slater Family Endowed Chair in Ophthalmology at the University of Colorado School of Medicine.
The Developing Novel Endpoints for Premium Intraocular Lenses workshop will take place on October 11, 2013, from 8:30 a.m. to 5:30 p.m. at the FDA White Oak campus in Silver Spring, Maryland. Registration is now open. Early registration is encouraged as space is limited. The cost is $250 for Academy members and $400 for non-members. To register and learn more, visit www.aao.org/IOLworkshop.
About the American Academy of Ophthalmology
The American Academy of Ophthalmology–headquartered in San Francisco– is the world's largest association of eye physicians and surgeons — Eye M.D.s — with nearly 32,000 members worldwide. Eye health care is provided by the three "O's" – ophthalmologists, optometrists, and opticians. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases, infections and injuries, and perform eye surgery. For more information, visit www.aao.org. The Academy's EyeSmart® program educates the public about the importance of eye health and empowers them to preserve healthy vision. EyeSmart provides the most trusted and medically accurate information about eye diseases, conditions and injuries. OjosSanos™ is the Spanish-language version of the program. Visit www.geteyesmart.org or www.ojossanos.org to learn more.
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