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.
Applied as a liquid, the product gels to form a barrier on the surface of the eye following cataract surgery, the most common eye surgery performed in the U.S., according to a press release.
Corneal wounds often leak following surgery, a condition believed to contribute to later complications. The current standard for treating these wounds, called stromal hydration, may leave patients with damaged vision during the early post-operative period, according to the company.
Read MassDevice.com’s exclusive interview with Amar Sawhney in CEO Insights 2012.
Ocular Therapeutix and is chief executive, serial entrepreneur Amar Sawhney, are looking to revolutionize eye care treatment with a handful of products challenging clinical standards.
Bedford, Mass.-based Ocular Therapeutix recently launched a Phase II trial of its punctum plugs, a possible eye-drop killer for patients with glaucoma or ocular hypertension.
The company’s travoprost-releasing punctum plug, designed to fit into the entry of the tear duct, releases drug therapy to the surface of the eye over several months.
In a video interview with MassDevice.com, Sawhney told us how he hopes his company’s eye-treatment products will make eye drops out of the system.
"This has been the holy grail of ophthalmology for a long period of time, to find a way to be able to tackle chronic long-term diseases like glaucoma," Sawhney told us. "When I talk to glaucoma patients who are not able or don’t remember to take their drops, we may think it’s a simple thing but they can’t do it."
Some studies report that up to 60% of glaucoma patients do not use their eye drops as directed, which can lead to costly and invasive eye surgeries, vision impairment and blindness, according to a press release.
