Ocular Therapeutix submits PMA for ReSure ophthalmic sealant

February 25, 2013 by Sony Salzman

Ocular Therapeutix applies for pre-market approval from the FDA CEO, hoping to win a green light for the U.S. market this year.

Ocular Therapeutix logo

There's nothing left for Ocular Therapeutix to do but sit back and wait for the FDA to decide on the pre-market approval application for its ReSure ophthalmic sealant.

The Bedford, Mass.-based medical device company is hoping to be able to get the sealant on the U.S. market this year based on a 488-patient clinical trial, CEO Amar Sawhney said in prepared remarks.

"We are very pleased with the results of the trial and we believe our data set is strong," Sawhney said. "Should FDA view our trial results favorably, we hope to have the opportunity to offer ReSure Sealant to U.S. clinicians later this year."

Sign up to get our free newsletters delivered right to your inbox.

The ReSure product is designed to seal corneal incisions after surgery for lens implants. Ocular Therapeutix has applied for 2 indications, 1 for wound leaks and 1 for prevention of post-op fluid flow.

Ocular Therapeutix last month closed a nearly $24 million Series D extension round. Sawhney told MassDevice.com at the time that it aims to use the proceeds for its punctum plug technology.

"There are many punctum plug-based products. We're focused on glaucoma and post-operative inflammation using a steroid," he told us. "Generally speaking, we would be doing Phase II trials for both of those indications next year. We would potentially be doing Phase III trials and after that, obviously, [FDA] submission would take place."

Comments