Bedford, MA-Ocular Therapeutix has completed enrollment for the pivotal clinical trial of a polyethylene glycol-based hydrogel (ReSure) to close clear corneal wounds after cataract extraction or IOL placement.
The company enrolled 488 patients at 24 sites throughout the United States in an effort to gain premarket approval from the FDA.
The randomized, parallel-arm clinical trial is investigating the safety and efficacy of the sealant, which is applied as a liquid and then gels to form a barrier on the ocular surface. If approved, it would be an alternative to the stromal hydration used by ophthalmologists to prevent postoperative fluid egress on clear corneal incisions.
“A product such as this may prompt physicians to re‐evaluate how they deal with their surgical wounds at the conclusion of each cataract procedure,” said Ralph Chu, MD, principal investigator at Chu Vision Institute, Bloomington, MN.
Amar Sawhney, PhD, president and chief executive officer of Ocular Therapeutix, said the company looks forward to submitting the study data to the FDA in hopes of the product being approved for use in the United States.
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