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news.Sun Pharma’s drug Seciera, indicated for the treatment of dry eye disease, has demonstrated positive results in a 12-week multicentre phase-3 clinical trial.
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The 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).
Sun Pharma said the demonstration of efficacy by Seciera at 12 weeks is earlier than other drugs approved for dry eye in the similar class.
In addition, various key secondary endpoints showed statistically significant improvements compared to vehicle with some demonstrating an even earlier onset of action.
Adverse events from the trial were found to be mild to moderate and similar to other approved drugs in the category.
The phase 3 results build on positive results from an earlier Phase 2b/3 trial of 455 patients.
Sun Pharma managing director Dilip Shanghvi said: "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."
Seciera is being developed by Ocular Technologies, a company which Sun Pharma recently acquired.
Sun Pharma holds exclusive, global rights to Seciera. The compamny is developing it to commercialize for worldwide markets including the US, Europe, and Japan, as well as other emerging markets.
Image: Sun Pharma research and development. Photo: courtesy of Sun Pharmaceutical Industries Ltd.