Santen Announces U.S. FDA Filling Acceptance of New Drug Application(NDA) for Cyclosporine Topical Ophthalmic Emulsion, 0.1% in the Treatment of Severe Vernal Keratoconjunctivitis in Patients Ages 4-18

October 26, 2020 Santen Announces U.S. FDA Filling Acceptance of New Drug Application (NDA) for Cyclosporine Topical Ophthalmic Emulsion, 0.1% in the Treatment of Severe Vernal Keratoconjunctivitis in Patients Ages 4-18 Santen Pharmaceutical Co., Ltd. (Head Office: Osaka City, hereafter Santen), 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 keratoconjunctivi tis (VKC) in patients ages 4-18. The FDA has set June 26, 2021 as the Prescription Drug User Fee Act (PDUFA) goal date. 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 th e 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% Cyclosporine topical ophthalmic emulsion, 0.1% is an investigational treatment for severe VKC in patients ages 4-18. Worldwide, it is available for the treatment of severe VKC in ten countries across Asia, Europe, and North America (Canada). About Vernal Keratoconjunctivitis VKC is a rare and recurrent allergic eye condition, most common in children and adolescents, that causes severe inflammation of the surface of the eye. The symptoms of VKC – intense itching, painful eyes and light sensitivity1,2 – can prevent those affected from participating in everyday activities.1,2,3 Approximately one-third of VKC cases are considered severe, and without adequate treatment may result in corneal ulcers and even vision loss.4 Contact Corporate Communications Group Santen Pharmaceutical Co., Ltd. E-mail: [email protected] Tel: +81 -6-4802-9360 _______________________________________________ 1 Kumar S. Vernal keratoconjunctivitis: a major review. Acta Ophthalmol 2009;87:133-147 2 Leonardi A. Management of vernal keratoconjunctivitis. Ophthalmol Ther. 2013;2:73e88 3 Sacchetti M, et al. Development and testing of quality of life in children with vernal keratoconjunctivitis questionnaire. Am J Ophthalmol 2007;144:557-563 4 Bremond-Gignac D, et al. Prevalence of vernal keratoconjunctivitis: a rare disease? Br J Ophthalmol 2008;92:1097-1102

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