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."
The Bedford, Mass.-based company closed a nearly $24 million Series D extension round in January, saying it planned to use the proceeds for the OTX-DP punctum plug technology it’s developing to deliver drugs to patients following cataract surgery. Ocular Therapeutix closed enrollment in a trial of the device in June.
Sawhney told MassDevice.com at the Big 100 East 2013 conference last month that the hydrogel technology he’s based several companies on has potential applications across a wide swath of medicine.
"I have been technology-centric, field-agnostic," Sawhney told the audience at the event. "I’m not stuck in 1 perfect little area. I’ve jumped from neurosurgery, spine surgery, ophthalmology, radiation oncology, etc., so it’s hard to become a deep-enough expert in each 1 of these critical areas."
Listen to Ocular Therapeutix CEO Sawhney discuss fundraising at the 2013 MassDevice Big 100
Working with the FDA is the hardest aspect of the medical device business, Sawhney told us at the event.
"Getting paid is getting harder, the reimbursement environment is challenging and the regulatory environment has gone from approvals to enforcement; a lot of inspections and stuff like that, so it just makes product development that much harder," he said, noting that the FDA could help matters.
"Focus some of its resources on getting more reviewers, for example. Be able to adhere to time lines and not just keep kicking the can down and making the review cycles longer," Sawhney said.