The U.S. Food and Drug Administration (FDA) has approved Santen Pharmaceutical’s cyclosporine ophthalmic emulsion 0.1% eye drops (Verkazia) for the treatment of vernal keratoconjunctivitis (VKC) in children and adults.
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 and may prevent those affected from participating in everyday activities, including school. Without adequate treatment, severe cases may result in corneal ulcers and even vision loss.
The FDA approval was largely based on data from two randomized clinical trials (VEKTIS Study and NOVATIVE study). In the VEKTIS study, patients with severe VKC were randomized to receive Verkazia 1 mg/mL four times daily, Verkazia 1 mg/mL two times daily, or vehicle twice daily for the first four months. Similarly, in the NOVATIVE study, patients with moderate to severe VKC were randomized to Verkazia 1 mg/mL four times daily, cyclosporine ophthalmic emulsion 0.5 mg/mL four times daily, or vehicle for the first month.
In both studies, Verkazia demonstrated improvements in inflammation of the cornea and ocular itching. The most common adverse reactions were eye pain and eye pruritus which were usually transitory.
Verkazia is an oil-in-water cationic emulsion that can improve the ocular bioavailability of cyclosporine, which attenuates the allergic inflammation observed in VKC.
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