Sun Pharma announces positive topline results of confirmatory Phase-3 clinical trial for Seciera for treatment of dry eye.
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 U.S., Europe, and Japan, as well as several emerging markets.
In the 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.
(Source: PR Newswire)
Filed Under: Drug Discovery
