US FDA Accepts Sun Pharma’s NDA for Dry Eye Candidate

December 29, 2017: By Jon Swedien

The US FDA has accepted Sun Pharmaceutical Industries’ new drug application (NDA) for OTX-101 for dry eye disease, the company announced Dec. 27.

OTX-101 (cyclosporine A, ophthalmic solution) 0.09% is a novel nanomicellar formulation in a clear, preservative-free aqueous solution. The NDA was filed by Sun Pharma’s wholly owned subsidiary, Sun Ophthalmics.

If approved, OTX-101 would be the third pharmaceutical drug for dry eye disease approved in the US market.

In a 12-week, multicenter, randomized, double-masked Phase III confirmatory study, 744 dry eye patients were treated either with OTX-101 or its vehicle. After the 12 weeks of treatment, OTX-101 showed statistically significant improvement in the primary endpoint, Schirmer’s score (p<0.0001), compared with vehicle, Sun Pharma said.

The study demonstrated the potential of OTX-101 to offer patients improved tear production with faster onset of action, Sun Pharma said.

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