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.
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.