The Medical Device Business Journal — Medical Device News & Articles | MassDevice
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.
Photograph by Carolyn Bick
Medtech super-entrepreneur Amar Sawhney has not been shy about sharing his success story.
Photograph by Carolyn Bick
"I have been technology-centric, field-agnostic," serial entrepreneur and Ocular Therapeutix president & CEO Amar Sawhney told an audience this week a the MassDevice Big 100 East 2013 conference in Waltham, Mass.
Photograph by Carolyn Bick
Nearly 300 of the industry’s best and brightest gathered for a night of big ideas, industry insights and few cocktails last night at MassDevice.com’s Big 100 East 2013 conference in Waltham, Mass.
Amar Sawhney at a meet-and-greet outside of President Barack Obama’s Chicago home.
Ocular Therapeutix wrapped up patient enrollment for a Phase II trial evaluating the company’s OTX-DP tear duct plug, the company announced this week.
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.
Ocular Therapeutix said it closed a $23.8 million Series D extension round from existing backers for its sustained drug release technology to treat eye diseases.
The Bedford, Mass.-based medical device company said all of its current institutional investors ponied up for the round, including Polaris Ventures, Versant Ventures, SV Life Sciences, Sparta LLC, and Ascension Health Ventures.
Ocular Therapeutix is developing a punctum plug for the entry of the tear duct to release drug therapy to the surface of the eye over several months.
Ocular Therapeutix touted 2-month clinical results for its glaucoma and ocular hypertension treating eye plug, a sustained-release drug-eluting punctum plug.
In a 20-patient clinical trial conducted in South Africa, researchers reported reduced intraocular pressure at 2 months with no excessive tearing or unanticipated adverse events, according to a press release. Findings were similar to treatment with topical brand name ophthalmic solutions, Ocular noted.
Ocular Therapeutix completed enrollment in a pivotal trail of its ReSure sealant, a hydrogel used to protect ocular incisions following eye surgery.
Findings from the 488-patient study will support the company’s bid for pre-market approval for ReSure, aiming for the agency’s approval to market the device in treating post-operative corneal wounds.
