FDA Advisory Committee Recommends Approval for Alcon’s Multifocal Toric Intraocular Lens for Cataract Patients
Nov 14, 2014
FORT WORTH, Texas, November 14, 2014– Alcon, the global leader in eye care, announced today that the U.S. Food and Drug Administration’s (FDA) Ophthalmic Devices Advisory Committee has recommended approval for AcrySof IQ ReSTOR Multifocal Toric Intraocular Lens (ReSTOR Toric IOL) for patients undergoing cataract eye surgery who are astigmatic and suffer from presbyopia.
The Advisory committee agreed by a 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.
"By combining two important technologies into one lens we can correct cataract patients’ presbyopia as well as their astigmatism," said Dr. Joanne Chang, Head of US Clinical and Regulatory Affairs at Alcon. "We are pleased that the advisory committee voted in support of the AcrySof IQ ReSTOR Multifocal Toric Intraocular Lens. We appreciate the thoroughness of the advisory committee’s examination of the data, and we will continue to work with the FDA as they finalize their review."
Data presented at today’s advisory committee meeting included results from a confirmatory clinical study (C-09-036) that involved more than 570 patients. The study, a prospective, non-randomized, parallel-group trial compared ReSTOR Toric IOL to ReSTOR Multifocal IOL with a +4.0 D add power in patients undergoing cataract eye surgery.
The study demonstrated that the ReSTOR Toric IOL provided patients with near, intermediate and distance vision; corrected astigmatism; and, provided patients with increased spectacle independence.
The primary safety objective was to estimate the rate of actual and potential secondary surgical interventions (SSI). The rate of actual or potential SSIs was low overall for the ReSTOR Toric IOL and similar to the Control IOL.
"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 today 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."
If approved by the FDA, Alcon will commercialize ReSTOR Toric IOLs in the United States. The product is already commercially available in the European Union, Australia, Canada, Japan and many other countries within Central and South America. More than 93,000 units of the ReSTOR Toric IOL have been sold in countries outside the US since 2010.
Unmet patient need More than three million cataract surgeries are performed each year; of those patients more than 50 percent have an astigmatism (Riley 2001, Ferrer-Blasco 2009).
Astigmatism is a variation in the shape or curvature of the cornea and, if left untreated, astigmatism can cause blurred vision at all distances. More than 50 percent of the patients who undergo cataract surgery have corneal astigmatism ≥ 0.75 D, which may significantly limit an optimal visual outcome if left uncorrected (Riley 2001, Ferrer-Blasco 2009).
Presbyopia is an eye condition that occurs as the natural part of aging. It involves the gradual loss of the eye's ability to actively focus on close objects, such as smart phones, computers, books and menus (Mayo Clinic. Presbyopia. [Accessed July 1, 2014]). Once a person is in their 40s, it is likely they will experience presbyopia. Worldwide, nearly 1.7 billion people experience vision issues due to presbyopia, and this number is expected to soar to more than 2 billion by 2020 (Market Scope. Global Presbyopia-Correcting Surgery Market Report, April 2012. [Accessed July 1, 2014]).
About Alcon: Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. The three Alcon businesses - Surgical, Pharmaceutical and Vision Care - offer the widest spectrum of eye care products in the world. Alcon is the second largest division of the Novartis Group, with pro-forma sales of USD 10.5 billion in 2013. Headquartered in Fort Worth, Texas, USA, Alcon has more than 25,000 employees worldwide, operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com.
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