The U.S. Food and Drug Administration has approved Verkazia (cyclosporine ophthalmic emulsion; Santen Inc) 0.1% eye drops for the treatment of vernal keratoconjunctivitis (VKC) in children and adults, according to a press release.
“This is an important milestone in Santen’s aim to bring innovative solutions that protect vision for those affected by rare ophthalmic conditions, and is the first prescription product approval for Santen in the U.S. market,” said Tatsuya Kaihara, CEO of Santen Inc. and Head of Santen North America in the press release. “If left untreated, VKC is associated with symptoms such as eye pain and vision loss that can have detrimental impacts on those it affects, including on school attendance and academic performance. With this approval, doctors and patients in the U.S. now have an effective and sustainable treatment for this rare condition that may allow those affected to continue taking part in everyday activities.”
Approval was based on data from the randomized, multi-center, double-masked, vehicle-controlled VEKTIS and NOVATIVE Studies which found keratitis score and ocular itching were improved in patients treated with Verkazia. The most common adverse reactions reported in greater than 5 percent of patients were eye pain (12%) and eye pruritus (8%).
Read the full press release here.