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# Santen NDA Accepted for Eye Condition
- URL: https://www.fdaweb.com/santen-nda-accepted-for-eye-condition/
- Published: 2020-10-26T12:00:00.000Z
- Updated: 2026-09-14T16:33:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147953

FDA has accepted for review a Santen NDA for cyclosporine topical ophthalmic emulsion, 0.1% for treating severe vernal keratoconjunctivitis (VKC) in patients aged 4-18 years. VKC is a rare and recurrent allergic eye condition, most common in children and adolescents, that causes severe inflammation on the eye’s surface. The symptoms of VKC (intense itching, painful eyes and light sensitivity) can prevent those affected from participating in everyday activities. “Approximately one-third of VKC cases are considered severe, and without adequate treatment may result in corneal ulcers and even vision loss,” the company says. The agency has set a user fee review action target date of 6/26/2021.