Surface Ophthalmics’ Chronic Dry Eye Study Reaches 50% Enrollment Milestone
Surface Ophthalmics, Inc. today announced that 50% of patients have been enrolled and randomized in the Phase II clinical trial for its investigational product SURF-100 (mycophenolate sodium and betamethasone sodium phosphate in Klarity vehicle) for the treatment of chronic dry eye disease. Having reached this milestone, the company is on track to announce top-line results from the trial in the first quarter of 2022.
“We’re thrilled by the recruitment rate in this clinical trial which, despite challenges posed by the COVID-19 pandemic, now includes 40 study sites from across the United States. We appreciate the support and tremendous work of all of our clinical investigators in achieving this milestone. At Surface, we’re committed to bringing therapies to market that will provide truly meaningful benefits for patients. By utilizing our core therapeutic building blocks, our goal is to bring dry eye patients a product that provides rapid onset of action, while also providing sustained clinical benefit, in a way that is soothing to the eye. We believe that the results from this clinical trial design will demonstrate how SURF-100 can offer eye care professionals and patients a unique treatment option for dry eye,” said Kamran Hosseini, MD, PhD, President and CEO of Surface Ophthalmics.
The clinical trial consists of multiple study arms, including arms which will directly compare SURF-100 with the current leading treatments for dry eye disease: lifitegrast ophthalmic solution 5% (marketed as Xiidra) and cyclosporine ophthalmic emulsion 0.05% (marketed as Restasis). The trial will enroll approximately 300 patients with a primary endpoint of statistically significant symptom improvement between various study arms based on the University of North Carolina Dry Eye Management Scale at day 84.
Dr. Hosseini continued,“One important result of this clinical investigational design is the potential of a direct, head-to-head comparison between Xiidraand Restasis, which has never been done in a well-controlled, FDA-approved clinical study. While this comparison was not the original purpose of this study, we are looking at the option to provide additional analysis, including the efficacy and safety results, to benefit the community.”