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The approval was supported by 2 trials demonstrating treatment efficacy in reducing ocular itching and inflammation in the cornea.
The US Food and Drug Administration (FDA) approved cyclosporine ophthalmic emulsion (Verkazia 0.1%) eye drops for the treatment of vernal keratoconjunctivitis (VKC) in adult and pediatric populations.
Patients with the rare, recurrent allergic eye condition experience severe inflammation on the surface of the eyes. Symptoms may include intense itching, painful eyes, and light sensitivity.
“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 a statement
“With this approval,” he continued, “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.”
The FDA approval was supported by 2 randomized, multicenter, double-blind, vehicle-controlled trials.
Patients in the VEKTIS study demonstrated severe VKS. They were randomized to 1 mg/mL cyclosporine ophthalmic emulsion 4 times daily, 1 mg/mL 2 times daily, or a vehicle group for the first 4 months.
Those randomized to the vehicle cohort were switched to cyclosporine 4 times daily or twice daily at month 4 through month 12.
The NOVATIVE study enrolled patients with moderate to severe VKC, who were then randomized to cyclosporine 1 mg/mL or 0.5 mg/mL 4 times daily, or a vehicle group through the first month.
After month 1, those receiving the vehicle switched over to either dose of cyclosporine through month 4.
Across both studies, the ophthalmic solution was associated with improvements in corneal inflammation, as measured by the keratitis score, and ocular itching.
The most commonly reported adverse events associated with the solution were eye pain (12%) and eye pruritis (8%). However, such reactions were considered mostly transitory.