Santen Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for Cyclosporine Topical Ophthalmic Emulsion, 0.1% for the Treatment of Severe Vernal Keratoconjunctivitis in Patients Ages 4-18
EMERYVILLE, Calif., Oct. 26, 2020 /PRNewswire/ -- Santen, Inc. the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on ophthalmology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for cyclosporine topical ophthalmic emulsion, 0.1% for the treatment of severe vernal keratoconjunctivitis (VKC) in patients ages 4-18. The FDA has set June 26, 2021 as the Prescription Drug User Fee Act (PDUFA) goal date.
"This is an important milestone for patients with severe vernal keratoconjunctivitis in the U.S. – especially children and adolescents – and the doctors who treat them," said Peter Sallstig, Senior Vice President and Global Head Product Development Division of Santen. "We look forward to working with the FDA during the review process and are optimistic this treatment could provide much needed symptom relief for those affected so they may better engage in their daily activities."
The NDA submission for cyclosporine topical ophthalmic emulsion, 0.1% is supported by data from VEKTIS (NCT01751126), a 12-month, randomized, multi-center, double-masked, vehicle-controlled, pivotal clinical trial. In the trial, patients were randomized to either the high dose group (administered 4 times daily), low dose group (administered 2 times daily), or vehicle group for the first 4 months (Period 1). Patients randomized to the vehicle group were switched to either the high or low dose group (administered 4 times or 2 times daily) from Month 4 to Month 12 (Period 2).
About Cyclosporine Topical Ophthalmic Emulsion, 0.1%
About Vernal Keratoconjunctivitis (VKC)
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4 Bremond-Gignac D, et al. Prevalence of vernal keratoconjunctivitis: a rare disease? Br J Ophthalmol 2008;92:1097-1102
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