SARcode Bioscience initiates enrollment in SAR 1118 Phase 3 study for dry eye disease

Sep 15 2011

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," commented Edward Holland, MD, a cornea specialist from the Cincinnati Eye Institute and consultant to SARcode Bioscience.  "It is exciting to see this new molecular entity, which was specifically designed for ocular use, enter pivotal trials.  If the Phase 3 program is successful, this novel therapy will provide a much needed treatment option that not only alleviates the symptoms of dry eye, but also improves visual-related quality-of-life for patients suffering from this disease."

SARcode Bioscience anticipates completion of the OPUS-1 study and topline data in mid-year 2012.

Source: SARcode Bioscience, Inc.