FDA Approves Cyclosporine Ophthalmic Emulsion 0.1% for Treatment of Vernal Keratoconjunctivitis

Cyclosporine ophthalmic emulsion (Verkazia; Santen Inc.) 0.1% has been approved by the FDA for the treatment of adults and children with vernal keratoconjunctivitis (VKC), a rare allergic eye condition.

VKC most commonly affects children and adolescents and causes severe inflammation on the surface of the eye. Symptoms can include intense itching, painful eyes, and light sensitivity, and severe cases may result in corneal ulcers and even vision loss.

“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,” said Tatsuya Kaihara, CEO of Santen Inc, in a press release. “With this approval, doctors and patients in the US now have an effective and sustainable treatment for this rare condition that may allow those affected to continue taking part in everyday activities.”

According to the press release, cyclosporine ophthalmic emulsion is a unique oil-in-water cationic emulsion that has improved ocular bioavailability of cyclosporine, which effectively manages VKC. It inhibits T-cell activation and reduces the level of immune cells and mediators which cause the inflammation seen in patients with VKC.

The safety and efficacy of the emulsion were evaluated in 2 randomized, multi-center clinical trials. In the VEKTIS study, patients with severe VKC were randomized to receive cyclosporine ophthalmic emulsion 1 mg/mL either 4 times daily or 2 times daily and vehicle group. In the NOVATIVE study, patients with moderate to severe VKC received either QID cyclosporine ophthalmic emulsion 1 mg/mL or QID of cyclosporine ophthalmic emulsion 0.5 mg/mL and vehicle group for the first month.

In both studies, patients randomized to the vehicle group were switched to receive Verkazia from month 4 to month 12 in the VEKTIS study and to receive cyclosporine ophthalmic emulsion 0.5 mg/mL QID or 1 mg/mL from month 1 to month 4 in the NOVATIVE study.

According to the press release, investigators observed improvements in inflammation of the cornea and ocular itching among patients receiving Cyclosporine ophthalmic emulsion in both trials. The most common adverse reactions reported in more than 5% of patients were eye pain (12%) and eye pruritus (8%), which were usually transitory and occurred during instillation.

REFERENCE

Santen Receives FDA Approval for Verkazia (Cyclosporine Ophthalmic Emulsion) 0.1% for the Treatment of Vernal Keratoconjunctivitis in Children and Adults [news release]. Santen; June 24, 2021. Email. Accessed June 24, 2021.