Surface Ophthalmics Announces First Patient Dosed in Phase 2 Trial for SURF-200 for Acute Dry Eye

Surface Ophthalmics announced that the first patient has been dosed in the phase 2 clinical trial for its investigational product SURF-200 (betamethasone in Klarity vehicle) for the treatment of acute dry eye.

In this dose-ranging study, SURF-200 will be studied in two different low concentration formulations which include betamethasone, a corticosteroid with a strong track record in global use but is now making its debut in the ocular space in the United States, in the Klarity vehicle. SURF-200 has been formulated to provide comparable efficacy with an improved safety and tolerability profile when compared to currently used steroids. The trial will enroll between 120-140 patients with a primary endpoint of Symptom Improvement of one unit based on the University of North Carolina Dry Eye Management Scale by the eighth day.

“We’re excited to have our first patient dosed for our SURF-200 phase 2 clinical trial,” Kamran Hosseini, MD, PhD, President and CEO, Surface Ophthalmics, said in a company news release. “Following last week’s initiation of the bold SURF-100 head-to-head clinical trial in chronic dry eye disease, we’re proud to be enrolling patients in clinical trials for both acute dry eye and chronic dry eye disease. We are the only company committed to working to meet all of the needs of dry eye patients.”

“With limited treatment options for acute dry eye, we have a great need for an effective and well-tolerated therapeutic for patients suffering from periods of acute dry eye,” Preeya Gupta, MD, Associate Professor of Ophthalmology at Duke University Eye Center, lead investigator for the SURF-200 clinical trial, said in the news release. “With a proven diluent designed to protect the ocular surface and a potent corticosteroid, I’m hopeful that SURF-200 will provide a much-needed treatment option.”

Surface Ophthalmics is advancing three clinical programs: one in chronic dry eye disease (SURF-100), one in acute dry eye (SURF-200), and one in pain and inflammation following ocular surgery (SURF-201). These programs utilize Klarity as the delivery vehicle, which is designed to enhance patient comfort as well as protect and rehabilitate the ocular surface.

In 2 years, Surface has filed three unique INDs and officially moved all three of the programs into phase 2 trials.