FDA Accepts Sun Pharma’s NDA for OTX-101 to Treat Dry Eye Disease

Source: Sun Pharmaceutical Industries

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

“Dry eye disease is a complex, chronic condition that affects patient quality of life, often significantly. OTX-101, a novel formulation of cyclosporine, will allow us to participate in the rapidly growing underserved and dynamic dry eye market," Dilip Shanghvi, managing director, Sun Pharma, said in a company news release. "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.”

After FDA approval, OTX-101 will be commercialized in the United States 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% to eye care practitioners across United States.

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 United States as soon as possible, and look forward to working closely with the US FDA over the coming months.”

OTX-101 is being evaluated for the treatment of dry eye disease. It is a patented, novel, proprietary nanomicellar formulation of cyclosporine A, 0.09%. It is a clear, preservative-free, aqueous solution. In a 12-week, multicenter, randomized, double-masked, vehicle controlled phase 3 confirmatory study, 744 dry eye patients were treated either with OTX-101, or its vehicle. After 12 weeks of treatment, as compared to vehicle, OTX-101 showed statistically significant improvement in the primary end point, Schirmer’s score (a measurement of tear production) (P<0.0001). The demonstration of efficacy by OTX-101 at 12 weeks is earlier than other drugs approved for dry eye in the same class.

Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle with some showing an even earlier onset of action. Adverse events reported in the trial were mild to moderate in nature and similar to other approved drugs in the category. As Sun continues to analyze the data, additional significant findings will be shared at upcoming medical conferences.

Previously, in a completed phase 2b/3 clinical trial in 455 patients, OTX-101 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 favorably to other formulations of cyclosporine A with the advantage of faster onset.

Sun Ohthalmics markets BromSite (bromfenac ophthalmic solution) 0.075% in the US. Other candidates in Sun Ophthalmics’ development pipeline include Xelpros (latanoprost ophthalmic solution) 0.005% and DexaSite (dexamethasone) 0.1%.

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