First patient dosed in phase 2 trial for chronic dry eye disease treatment
The first patient has been dosed in the phase 2 clinical trial for SURF-100 (mycophenolate sodium and betamethasone sodium phosphate in Klarity vehicle) for the treatment of chronic dry eye disease, according to a press release by Surface Ophthalmics, Inc.
The clinical trial will enroll approximately 300 patients and compare SURF-100 with lifitegrast ophthalmic solution 5% (Xiidra; Shire US Inc) and cyclosporine ophthalmic emulsion 0.05% (Restasis; Allergan). The primary endpoint is statistically significant Symptom Improvement between study arms based on the University of North Carolina Dry Eye Management Scale at Day 84.
“With the first patient enrolled, we’re excited to be initiating this bold trial which is not only the first head-to-head trial in chronic dry eye, but also will be the most expansive Phase II trial initiated to-date including the greatest number of arms with multiple active investigational arms at different strengths,” said Kamran Hosseini, MD, PhD, President and CEO, Surface Ophthalmics, in the press release. “By having SURF-100 go head-to-head with the leading marketed therapies, we hope to demonstrate clear advantages in both efficacy and, perhaps even more importantly, patient comfort and tolerability. We want to provide patients with the answers they need to find the best treatment option for their dry eye disease.”
Read the full press release here.