Atlixco

Researchers are conducting a phase 3, randomized, double-masked clinical trial to evaluate the safety and effectiveness of cenegermin ophthalmic solution compared with a vehicle solution in treating Persistent Corneal Epithelial Defect PCED. The main goal is to assess whether cenegermin can induce complete healing of the corneal epithelium after 4 weeks of treatment. This multicenter study involves participants with PCED that has not improved with conventional nonsurgical treatments. Participants will be randomly assigned to receive either cenegermin or a matching vehicle solution applied topically to the affected eye. The study includes three periods an initial 8-week treatment phase Day 1 to Week 8, an 8-week extension treatment phase Week 9 to Week 16, and a 24-week follow-up phase Week 17 to Week 40. The dosing schedule and administration details are aligned with these periods to monitor healing and safety outcomes. Throughout the trial, participants will undergo regular assessments including measurements of the corneal defect size and evaluations of complete epithelial healing at specified weeks. Researchers will also monitor for any treatment-emergent adverse events and participants who discontinue due to intolerability. The total participation duration can last up to 40 weeks, covering treatment and follow-up to evaluate sustained healing and safety.