FDA Accepts Santen’s NDA for Cyclosporine Topical Ophthalmic Emulsion for the Treatment of Severe Vernal Keratoconjunctivitis in Patients Ages 4-18
Santen announced that the 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,” Peter Sallstig, Senior Vice President and Global Head Product Development Division of Santen, said in a company news release. “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, multicenter, 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).
Cyclosporine topical ophthalmic emulsion, 0.1% is available for the treatment of severe VKC in ten countries across Asia, Europe, and North America (Canada).
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 sensitivity–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
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