Sun Pharma announced successful phase 3 confirmatory clinical trial results for Seciera (cyclosporine A, 0.09% ophthalmic solution), for the treatment of dry eye disease. Seciera is a patented, novel, proprietary nanomicellar formulation of cyclosporine A 0.09%. It is a clear, preservative-free, aqueous solution. Seciera is being developed by Ocular Technologies, a company recently acquired by Sun Pharma. Following this acquisition, Sun Pharma owns exclusive, worldwide rights to Seciera and is developing it to commercialize for global markets including US, Europe, and Japan, as well as several emerging markets.
In this 12 week, multicenter, randomized, double-masked, vehicle controlled phase 3 confirmatory study, 744 dry eye patients were treated either with Seciera, or its vehicle. After 12 weeks of treatment, as compared to vehicle, Seciera showed statistically significant improvement in the primary end point, Schirmer's score (a measurement of tear production) (p<0.0001). The demonstration of efficacy by Seciera at 12 weeks is earlier than other drugs approved for dry eye in the same class. Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle with some showing an even earlier onset of action. Adverse events reported in the trial were mild to moderate in nature and similar to other approved drugs in the category. As Sun continues to analyze the data, additional significant findings will be shared at upcoming medical conferences.
Previously, in a completed phase 2b/3 clinical trial in 455 patients, Seciera demonstrated a rapid onset of action and was well tolerated by the study population. Based on published data, the efficacy and safety endpoints in these trials compared favorably to other formulations of cyclosporine A with the advantage of early onset.
According to Dilip Shanghvi, managing director, Sun Pharma, "We are happy to see the early onset of action and strong efficacy results for Seciera. These results are highly encouraging for millions of Dry Eye patients across the globe that have yet to find relief for their condition. We look forward to discussing these results with US FDA and agree on next steps for the program."
"I am very excited to see these strong results for Seciera," noted Dr. Joseph Tauber, Study Investigator and founder of the Tauber Eye Center, Kansas City, Missouri. "As a clinician who specializes in diagnosing and treating dry eye, this novel formulation of cyclosporine A would be a unique and welcome addition to our armamentarium to treat these patients".
Jerry St. Peter, vice president and head of Sun Ophthalmics, added, "A key strategic imperative for our ophthalmic business is to participate in the rapidly growing, underserved, and dynamic dry eye market, which is expected to reach $5 billion by 2020. Based on this successful confirmatory phase 3 trial, Seciera has the potential to strengthen our emerging ophthalmics pipeline, which includes the recent launch of BromSite and late stage development programs for Xelpros and DexaSite."