NOV 19, 2014
Cataract/Anterior Segment, Refractive Mgmt/Intervention
The U.S. FDA’s Ophthalmic Devices Advisory Committee has recommended premarket approval of Alcon’s AcrySof IQ ReSTOR +3.0 D Multifocal Toric IOL for patients undergoing cataract surgery who are astigmatic and suffer from presbyopia.
The 12-member Committee agreed by unanimous vote that the available clinical data demonstrate a favorable benefit-risk profile. While the FDA is not obligated to follow the recommendations of its advisory panels, it typically does so.
"There is presently an unmet medical need for a multifocal intraocular lens that can correct for spherical error, astigmatism, and near vision in a single surgical procedure for patients desiring less dependence on spectacle correction after cataract surgery," said Dr. Stephen Lane, Medical Director, Associated Eye Care and Adjunct Clinical Professor at the University of Minnesota. "The data presented [to the Committee] demonstrated a favorable benefit-risk ratio that I believe will translate into an exciting new treatment option for my patients and my colleagues’ patients across the US, without the requirement of additional surgical procedures."
Data presented to the Committee included results from a large prospective, non-randomized study comparing the ReSTOR Multifocal Toric IOL to the ReSTOR Multifocal IOL with a +4.0 D add power in patients undergoing cataract surgery. Results demonstrated that the ReSTOR Toric Multifocal IOL provided patients with near, intermediate and distance vision, corrected astigmatism, and increased spectacle independence, with a low rate secondary surgical interventions.
The ReSTOR Multifocal Toric IOL is already available in the European Union, Australia, Canada, Japan and many other countries in Central and South America, with more than 93,000 units sold outside the US since 2010.