Alcon Laboratories won a date before an FDA advisory panel in November to review the data behind its application for a new indication for its AcrySof IQ ReSTOR intraocular lens, the watchdog agency said today.
The AcrySof IQ ReSTOR lens is already approved in the U.S. to treat presbyopia and cataracts.
Now the FDA’s Ophthalmic Devices panel is slated to meet Nov. 14 to recommend whether the agency approve the device for treating aphakia, or lack of lens, and for replacing the lens after cataract surgery, according to a press release.
Intraocular lens sales ebbed during the 1st half of the year for Alcon, which was acquired for $12.9 billion by Novartis (NYSE:NVS) in 2010, global head Jeff George said in July. The declines were due to loss of market share in Europe and Asia, competition from other toric lens makers and severe winter weather last year in the U.S., George said during a conference call.
"IOL performance over the last few quarters hasn’t been as good as we would like," he said. "We’ve put in place a number of measures since I’ve taken over in the last couple of months … A number of launches, I think, will work in our favor."
Alcon, which generated sales of $10.5 billion last year, has had its U.S. headquarters in Fort Worth, Texas, since its 1945 founding. The company employs about 24,000 people.