FDA Approves Santen’s Verkazia to Treat Vernal Keratoconjunctivitis in Children and Adults

The U.S. Food and Drug Administration approved Santen’s Verkazia (cyclosporine ophthalmic emulsion) 0.1 percent eye drops for the treatment of vernal keratoconjunctivitis in children and adults.

Photo: Tatsuya Kaihara, CEO of Santen, Inc. and head of Santen North America.

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 sensitivity–can prevent those affected from participating in everyday activities, and without adequate treatment, severe cases may result in corneal ulcers and vision loss.

“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. “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 United States now have an effective and sustainable treatment for this rare condition that may allow those affected to continue taking part in everyday activities.”

Verkazia is a prescription-only, oil-in-water cationic emulsion that provides improved ocular bioavailability of cyclosporine, which has been shown to be effective in the management of VKC. It works by inhibiting T-cell activation and reducing the level of immune cells and mediators that cause the chronic, severe, potentially debilitating allergic inflammation of the ocular surface that is seen in those affected by VKC. Worldwide, Verkazia is available for the treatment of VKC in select countries across Asia, Europe, and North America.

Approval of Verkazia was based on two randomized, multi-center, double-masked, vehicle-controlled clinical trials that evaluated its safety and efficacy, the VEKTIS study and the NOVATIVE study. In the studies, Verkazia demonstrated improvements in inflammation of the cornea (keratitis score) and ocular itching. The most common adverse reactions reported in greater than 5 percent of patients were eye pain (12 percent) and eye pruritus (8 percent), which were usually transitory and occurred during instillation.

Author: Rare Daily Staff