FDA accepts new drug application for pediatric vernal keratoconjunctivitis treatment
The FDA has accepted Santen’s new drug application for cyclosporine topical ophthalmic emulsion 0.1% to treat patients aged 4 to 18 years with severe vernal keratoconjunctivitis, according to a press release.
The submission was supported by data from the 12-month, randomized, multicenter, double-masked, vehicle-controlled pivotal clinical VEKTIS trial. Patients were randomly assigned to receive high or low doses of the treatment or vehicle, with patients in the vehicle group later switched to the high- or low-dose treatment group.
“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 the release.
The Prescription Drug User Fee Act goal date is June 26, 2021.