Santen earns FDA approval for cyclosporine ophthalmic emulsion eye drops to treat vernal keratoconjunctivitis

Santen Inc. announced Thursday that the U.S. FDA has approved Verkazia (cyclosporine ophthalmic emulsion) 0.1% eye drops to treat vernal keratoconjunctivitis (VKC).

According to the company, Verkazia is a prescription-only oil-in-water cationic emulsion that supplies better ocular bioavailability of cyclosporine. Cyclosporine has proven effective in managing VKC.

Verkazia prevents T-cell activation and decreases immune cells and mediators that lead to chronic, severe and — potentially — debilitating allergic inflammation of the ocular surface associated with VKC.

A rare and recurrent allergic eye condition, VKC causes severe inflammation of the surface of the eye, and is most prevalent in children and adolescents.

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, according to Tatsuya Kaihara, Santen Inc CEO and Head of Santen North America, in a company news 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," he said in a statement.

Safety and efficacy of Verkazia was evaluated in two randomized multi-center, double-masked, vehicle-controlled, clinical trials: VEKTIS and NOVATIVE.

The VEKTIS study consisted of patients with severe VKS being randomized to four times a day of Verkazia 1 mg/mL, or two times a day of Verkazia 1 mg/mL and vehicle group for the first four months (Period 1), according to the company.

The NOVATIVE study included patients with moderate to severe VKC who 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), the company stated.

In both the VEKTIS and NOVATIVE study, patients who were randomized to the vehicle group were switched to Verkazia (QID or BID) from Month 4 to Month 12 (in the VEKTIS study), and to cyclosporine ophthalmic emulsion 0.5 mg/mL QID or 1 mg/mL from Month 1 to Month 4 (in the NOVATIVE Study) (Period 2), according to the company.

Verkazia showed improvements in inflammation of the cornea (keratitis score) and ocular itching in both studies, the company reported.

The most common negative reactions reported by patients included eye pain (12%) and eye pruritus (8%), which were usually transitory and occurred during instillation, according to the company.

Santen initially received FDA filing acceptance last October. With this latest approval, the company is now working to make a new treatment option available for US patients.

References

1. Santen Inc. Santen Receives FDA Approval for Verkazia (Cyclosporine Ophthalmic Emulsion) 0.1% for the Treatment of Vernal Keratoconjunctivitis in Children and Adults. Available at https://www.santen.com/en/news/20210624-2.pdf. Accessed 6/24/21.