FDA approves Verkazia for vernal keratoconjunctivitis
The FDA has approved a new drug application for Verkazia for the treatment of vernal keratoconjunctivitis in children and adults, according to a press release from Santen Pharmaceutical Co.
The application for Verkazia (cyclosporine ophthalmic emulsion 0.1%) was accepted by the FDA in October 2020. The approval was based on data from the pivotal VEKTIS study and the phase 2/3 NOVATIVE study that showed Verkazia demonstrated improvements in corneal inflammation and ocular itching, the release said.
“This is an important milestone in Santen’s aim to bring innovative solutions that protect vision for those affected by ophthalmic conditions,” Tatsuya Kaihara, CEO of Santen Inc. and head of Santen North America, said in the release. “With this approval, doctors and patients in the United States now have an effective and new treatment for this rare condition that may allow those affected to continue taking part in everyday activities.”
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