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

Surface Ophthalmics announced the first patient has been dosed in the Phase II 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 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 II clinical trial. 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," Kamran Hosseini, MD, PhD, President and CEO, Surface Ophthalmics, said.

"With limited treatment options for acute dry eye, we have a great need for an effective and well-tolerated therapeutic for patients suffering from periodsof acute dry eye," said Preeya Gupta, MD, Associate Professor of Ophthalmology at Duke University Eye Center, lead investigator for the SURF-200 clinical trial. "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."

"At Surface Ophthalmics, we are off to a great start in 2021! We began the year with positive topline Phase II data from SURF-201 for pain and inflammation following ocular surgery," said Hosseini. "Then we initiated two additional Phase II trials - first a head-to-head trial for SURF-100 against Restasis® and Xiidra® and now SURF-200 for acute dry eye. We're focusing on strong clinical progress this year and look forward to sharing more information as it becomes available."