Massachusetts medical device maker Ocular Therapeutix announced today that it won FDA premarket approval for its flagship ReSure sealant, a hydrogel designed to help heal surgical wounds in the eye.
ReSure is the 1st and only sealant with FDA approval for ophthalmic use, providing an alternative to surgical sutures. Ocular plans to initiate a phased roll-out of the ReSure product, aiming for nation-wide launch by the middle of the year, president & CEO Amar Sawhney told MassDevice.com today.
"Transitioning from a development company to a commercial company takes time, you can’t expect to just flip a switch and make anything happen," Sawhney told us. "Cataracts are the most commonly performed surgery in the U.S. For a small company like ours to suddenly take on these many procedures, we would be arrogant if we thought that we could just do it overnight."
The road to FDA approval wasn’t always a smooth one, Sawhney added. Approval, "took a long time," but the company’s relationship with the FDA improved over the course of the review.
"We started working with the agency and listened to their feedback and then the process improved," he told us. "While it was disappointing to have to redo some of the clinical studies, it was a collaborative effort towards the end."
Sawhney is excited and optimistic about the road ahead, but nonetheless feels the burden of the medical device tax hanging over the company.
"We’re not looking forward to paying the tax," he said. "It starts with the 1st dollar of revenue and not with any profits, so even before we have our foot out of the hole, in terms of being able to make the company self-sustaining, we will have to be paying taxes."
"It’s not, I don’t think, a very fair situation," he said.
Listen to Ocular Therapeutix CEO Sawhney discuss fundraising at the 2013 MassDevice Big 100
Ocular Therapeutix filed for PMA approval in February 2013, based on a 488-patient clinical trial. The application sought approval for 2 indications, 1 for wound leaks and another for prevention of post-operative fluid flow.
An FDA panel in September recommended that the FDA approve ReSure, although panelists were split on questions of efficacy and whether the benefits of the device outweigh its risks. Some panelists said they were unable to adequately assess the benefits vs. the risks of ReSure or whether it proved superiority over suture, given the conduct of the study, which included 370 protocol deviations.