-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.

News

A new sealant (ReSure, Ocular Therapeutix) will be studied for clear corneal incision closure after cataract extraction or IOL placement.