Verisyse FDA approval announced during OSN Symposium

NEW YORK — The Food and Drug Administration late on Friday approved the Verisyse phakic IOL for the treatment of patients with myopia, officials from Advanced Medical Optics and Ophtec announced, making it the first phakic IOL approved for use in the United States. The lens is approved with a range of –5 D to –20 D, with up to 2.5 D of astigmatism.

Richard L. Lindstrom, MD, Chief Medical Editor of Ocular Surgery News, has been studying the lens in clinical trials for about 6 years. “It will be nice to have patients have access to it outside of clinical trials. It should be the treatment of choice for extreme myopes,” Dr. Lindstrom said Saturday in New York at the Ocular Surgery News Symposium: Cataract, Glaucoma & Refractive Surgery, where the approval was first publicly announced.

The Verisyse lens is manufactured by Ophtec. AMO obtained exclusive distribution rights to the lens in the United States and Japan in 2002 and markets the lens under the name Verisyse. Ophtec distributes the lens in other markets under the name Artisan. Opthec USA filed a pre-market approval application with the FDA in July 2003. The lens received expedited review status from the FDA in August 2003, said Rick McCarley, president and chief executive officer of Ophtec USA.

AMO is currently coordinating surgeon training and certification for the Verisyse lens in the U.S. and expects to begin releasing the product to trained surgeons by October, according to a joint press release issued by AMO and Ophtec.

According to AMO officials, there are 121 surgeons in the United States who are trained to implant this lens. The company projects that there will be about 200 trained surgeons in the United States by the end of the 2004, with between 400 and 500 trained surgeons in the United States by the end of 2005.