An FDA advisory panel will review the ReSure sealant made by Ocular Therapeutix, a hydrogel designed to seal incisions in the eye's cornea.
UPDATED August 2, 2013, at 2:15 p.m. with comment from Ocular Therapeutix CEO Amar Sawhney
An FDA advisory panel is slated to convene Sept. 19 to review the pre-market approval application for Ocular Therapeutix Inc.'s ReSure sealant.
The FDA's Ophthalmic Devices Panel will review the PMA for the ReSure product, a hydrogel designed to seal incisions to the cornea made during cataract or intraocular lens placement surgery.
Ocular Therapeutix filed for PMA approval in February, based on a 488-patient clinical trial. The application seeks approval for 2 indications, 1 for wound leaks and another for prevention of post-operative fluid flow. The FDA panel will consider whether the ReSure trial met its safety and efficacy endpoints well enough to merit approval. The agency is not bound by the recommendations of its advisory panels, but often follows their advice.
Ocular Therapeutix president & CEO Amar Sawhney told MassDevice.com today that the company is still hoping to get ReSure on the market this year.
"We are excited to get this 1st-of-a-kind device in front of the FDA panel. We feel we have a strong data package and we're optimistic in moving forward," Sawhney told us. "The problem is it's very difficult to know how soon the product will be approved [following the panel meeting]. We are optimistic we'll be able to get the product on the market this year."
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