Saturday, July 31, 2021

FDA Approves Verkazia (cyclosporine ophthalmic emulsion) for the Treatment of Vernal Keratoconjunctivitis

Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on eye care, today announced that the U.S. Food and Drug Administration (FDA) has approved Verkazia (cyclosporine ophthalmic emulsion) 0.1% eye drops 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. The symptoms of VKC – intense itching, painful eyes and light sensitivity – can prevent those affected from participating in everyday activities.1,2,3 Without adequate treatment, severe cases may result in corneal ulcers and even vision loss.4

“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 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.”

How Verkazia Works
Verkazia is a prescription-only, uniquely-formulated 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.

Verkazia Clinical Data
The safety and efficacy of Verkazia for the treatment of VKC was evaluated in two randomized, multi-center, double-masked, vehicle-controlled, clinical trials (VEKTIS Study and NOVATIVE Study). In the VEKTIS study, patients with severe VKC were randomized to four times daily of Verkazia 1 mg/mL or two times daily (BID) of Verkazia 1 mg/mL and vehicle group for the first 4 months (Period 1). Similarly, in the NOVATIVE study, patients with moderate to severe VKC were randomized to QID of Verkazia 1 mg/mL or QID of cyclosporine ophthalmic emulsion 0.5 mg/mL and vehicle group for the first 1 month (Period 1). In both studies, patients randomized to the vehicle group were switched to Verkazia (QID or BID) from Month 4 to Month 12 in VEKTIS Study and to cyclosporine ophthalmic emulsion 0.5 mg/mL QID or 1 mg/mL from Month 1 to Month 4 in NOVATIVE Study (Period 2).

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%) and eye pruritus (8%), which were usually transitory and occurred during instillation.

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