American Academy of Ophthalmology Teams with FDA in Effort to Get Premium Optical Medical Devices to Market Faster

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. 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.