EyeGate Pharmaceuticals’ Ocular Bandage Gel eye drop improved corneal re-epithelialization better than a bandage contact lens in a pivotal PRK study, thus achieving the study’s primary endpoint, according to a press release.
A total of 80.2% of patients who received the eye drop after PRK experienced complete corneal defect closure in 3 days compared with 67% of patients who received the standard-of-care bandage contact lens, a statistically significant difference favoring the eye drop (P = .0203). The study included 234 subjects, and primary endpoint outcomes were determined in masked fashion.
“This allows us to submit a de novo application for commercialization, which we plan to do in the first half of 2020,” Stephen From, EyeGate’s CEO, said.
If approved, the product will not only be the first indicated to repair corneal defects but also the first prescription hyaluronic acid eye drop in the U.S., “providing a huge opportunity for EyeGate,” From said.
Additional topline data are expected in December.