Positive Phase 3 Results for Dry Eye Disease Candidate
Sun Pharma announced successful Phase 3 results for Seciera (cyclosporine A, 0.09% ophthalmic solution), for the treatment of dry eye disease. Seciera is a preservative-free, aqueous solution with a proprietary nanomicellar formulation of cyclosporine A 0.09%.
The 12 week, multicenter, randomized, double-blind, vehicle controlled Phase 3 confirmatory study included 744 patients. The primary endpoint of statistically significant improvement in Schirmer's score (a measurement of tear production) was reached with Seciera at week 12, compared to vehicle (P<0.0001).
The Phase 3 results build on positive results from a previous Phase 2b/3 trial of 455 patients. Adverse events from the trial were reported to be mild to moderate and similar to other approved drugs in the category.
“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,” said Dr. Joseph Tauber of the Tauber Eye Center and the lead study investigator.
For more information visit Sunpharma.com.