PLEASANTON, Calif., May 6, 2021 /PRNewswire/ -- Surface Ophthalmics, Inc., a pharmaceutical company focused on the development and commercialization of innovative therapeutics for ocular diseases, 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," said Kamran Hosseini, MD, PhD, President and CEO, Surface Ophthalmics. "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."
The landmark 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."
ABOUT OUR CLINCIAL PROGRAMS Surface Ophthalmics is advancing three clinical programs: one in chronic dry eye disease (SURF-100), one in acute dry eye disease (SURF-200), and one in pain and inflammation following ocular surgery (SURF-201). These programs utilize Klarity® as the delivery vehicle, which has a proven track record of protecting and rehabilitating the ocular surface.
In only two years, Surface has filed three unique INDs and moved all three programs into Phase II clinical studies.
ABOUT KLARITY® The patented Klarity® delivery vehicle is used across Surface Ophthalmics' three current clinical programs. Developed by Richard L. Lindstrom, MD, inventor of Optisol GS (an advanced corneal preservation solution), Klarity is designed to protect and rehabilitate the ocular surface pathology for patients with moderate-to-severe dry eye disease.
ABOUT SURFACE OPHTHALMICS
Surface Ophthalmics, Inc. is a pharmaceutical company focused on development and commercialization of innovative therapeutics for ocular diseases. We are striving to solve key patient needs in eye care through leveraging deep expertise, a bold approach, an eye toward efficiency, and clear, differentiated clinical advantages. Our current drug pipeline consists of three proprietary drug candidates, all utilizing Klarity®, a patented delivery vehicle. We are led by an experienced and proven management team and board of directors with over 80 years of ophthalmology related professional experience. For more information: http://surfaceophthalmics.com/.