Ocular Therapeutix will conduct a pivotal clinical trial with a proprietary synthetic hydrogel polymer (ReSure Sealant) over clear corneal incisions after having received an investigational device exemption from the FDA.
Bedford, MA-Ocular Therapeutix will conduct a pivotal clinical trial with a proprietary synthetic hydrogel polymer (ReSure Sealant) over clear corneal incisions after having received an investigational device exemption from the FDA.
The hydrogel polymer is applied as a liquid and gels in situ on the ocular surface, creating a surface barrier. It is designed to stay on the incision in the immediate postoperative period, when wounds are most vulnerable, after which it sloughs off in a patient’s tears.
The randomized, parallel-arm clinical trial will test the safety and efficacy of the hydrogel polymer, relative to sutured closure, for the prevention of postoperative fluid egress on clear corneal incisions following cataract or IOL placement surgery. The trial will be conducted at up to 24 sites throughout the United States.
If successful, use of the hydrogel polymer would provide an alternative to the stromal hydration technique currently used by ophthalmologists to close those wounds, perhaps reducing clear corneal wound leaks that can contribute to post-surgical complications.
“We are very excited to have developed a robust study with [the] FDA’s input to demonstrate definitively the utility of the [hydrogel polymer] compared [with] older methods of incision closure and management in clear corneal cataract surgery,” said Amar Sawhney, president and chief executive officer of Ocular Therapeutix. “We look forward to completing the trial and making the [hydrogel polymer] available to U.S. physicians by next year.”
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