Express Pharma

Sun Pharma announces US FDA acceptance of NDA for OTX-101

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OTX-101 is being evaluated for treatment of dry eye disease

Sun Pharma has announced that the US FDA has accepted a New Drug Application (NDA), filed by its wholly owned subsidiary, for OTX-101 (cyclosporine A, ophthalmic solution) 0.09%, a novel nanomicellar formulation of cyclosporine A 0.09 per cent in a clear, preservative-free aqueous solution. OTX-101 is now under review for approval by the US FDA, marking an important developmental milestone for Sun Pharma’s dry eye candidate.

Dilip Shanghvi, MD, Sun Pharma, said, “OTX-101, a novel formulation of cyclosporine, will allow us to participate in the rapidly growing underserved and dynamic dry eye market. When approved, it will be a milestone for millions of Dry Eye patients across the globe that are yet to find relief for their condition.”

Post the US FDA approval, OTX-101 will be commercialised in the US by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly-owned subsidiary, based in Princeton, New Jersey. Sun Ophthalmics, founded in 2015, currently markets BromSite (bromfenac ophthalmic solution) 0.075 per cent to eye care practitioners across US.

Commenting on the development Abhay Gandhi, CEO – North America Business, Sun Pharma, said, “We are excited about the acceptance of this filing by the US FDA. In January 2017, we had announced positive topline results of confirmatory Phase-3 clinical trial for OTX-101, demonstrating both efficacy and faster onset of action in a trial environment. The 12-week trial saw 744 dry eye patients being treated either with OTX-101, or its vehicle. Compared to the vehicle, OTX-101 showed statistically significant improvement in the primary end point in the trial. The demonstration of efficacy of OTX-101 was earlier than other drugs approved for dry eye in the same class. We hope to bring OTX-101 to patients in the US as soon as possible, and look forward to working closely with the US FDA over the coming months.”

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