First Patient Enrolled in SARcode Bioscience's Pivotal Dry Eye Study of SAR 1118 Ophthalmic Solution
BRISBANE, Calif., Sept. 14, 2011 /PRNewswire/ -- SARcode Bioscience, Inc., a privately-held biopharmaceutical company, announced today that the initial patient has been enrolled in the company's pivotal Phase 3 clinical study (OPUS-1) of SAR 1118 ophthalmic solution.
SAR 1118 is a first-in-class molecule that inhibits T-cell inflammation by blocking the binding of two key cellular surface proteins (LFA-1 and ICAM-1) that mediate the chronic inflammatory cascade. SAR 1118 may be able to reduce inflammation associated with dry eye disease.
The OPUS-1 trial will study the safety and efficacy of SAR 1118 in the treatment of dry eye disease. Approximately 588 patients will be randomized to receive SAR 1118 5.0% ophthalmic solution or placebo twice daily over 12 weeks. The co-primary endpoints of the study are corneal fluorescein staining score and visual-related function score (reading, driving at night, computer use, and watching television) as measured by the Ocular Surface Disease Index (OSDI), a validated instrument designed to assess the impact of dry eye upon vision-related activities. The safety and tolerability of SAR 1118 compared to placebo at 12 weeks will also be evaluated.
"The OPUS-1 study aims to replicate the positive results observed in the Phase 2 dry eye trial, which demonstrated increases in tear production as early as 2 weeks, an improvement in corneal staining, and better visual-functional outcomes in the SAR 1118 treatment groups compared to placebo," said Charles Semba, MD, Chief Medical Officer. "Initiating patient enrollment in our Phase 3 trial is a significant milestone for SARcode Bioscience as we continue to progress towards our goal of making this therapy commercially available to millions of dry eye sufferers."
"Dry eye is an extremely common and significant problem encountered by eye care professionals," comm