FDA approves EyeGate PRK pivotal study
The FDA has approved a PRK pivotal clinical study from EyeGate Pharmaceuticals, according to a press release.
The company’s OBG platform, based on cross-linked thiolated carboxymethyl hyaluronic acid, helps with hydrating and healing the ocular surface. It is suited for ocular surface injuries because it adheres longer to the ocular surface, resists degradation and protects the ocular surface, the release said.
“We expect to receive topline results by year-end 2019 and, assuming these are positive, plan to submit a de novo application for commercialization shortly thereafter,” EyeGate CEO Stephen From said in the release. “Our OBG platform, if approved, will be the first prescription hyaluronic acid eye drop formulation in the U.S. market, providing a huge opportunity for us.”
The company will modify the patient informed consent document to comply with requests from the FDA before beginning study enrollment this month, the release said.