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Sun Pharma successfully conducts Phase-3 clinical trial for Seciera

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Seciera, developed by Ocular Technologies, will be used for the treatment of dry eye

Sun Pharmaceutical Industries announced successful Phase 3 confirmatory clinical trial results for Seciera (cyclosporine A, 0.09 per cent ophthalmic solution), for the treatment of dry eye disease. Seciera is a patented, novel, proprietary nanomicellar formulation of cyclosporine A 0.09 per cent. 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 commercialise for global markets including the US, Europe, and Japan, as well as several emerging markets.

In this 12 week, multicentre, randomised, 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).

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 favourably to other formulations of cyclosporine A with the advantage of early onset.

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