FDA Approvals Roundup: Verkazia
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).New approvals
Verkazia okayed for treating vernal keratoconjunctivitis
Santen’s Verkazia (cyclosporine ophthalmic emulsion) 0.1% eye drops has been approved for treating vernal keratoconjunctivitis (VKC) in children and adults.
VKC is a rare and debilitating allergic inflammation of the eye surface that is most common in children and adolescents. Verkazia’s oil-in-water formulation works by inhibiting T-cell activation and reducing the level of immune cells and mediators that cause the severe and recurring inflammation of the ocular surface.
Approval of Verkazia was based on safety and efficacy findings in the randomized, multicenter, double-masked, vehicle-controlled VEKTIS and NOVATIVE studies in 168 and 118 patients, respectively, aged 4 through 17 years and 4 through 21 years. In the VEKTIS study, Verkazia’s efficacy was demonstrated by improvements in inflammation of the cornea and ocular itching over 4 months. Similar findings after 1 month in the NOVATIVE study provided supporting evidence of efficacy.
Cyclosprine is an immunosuppressive agent that is available under other brand names in formulations for treating organ rejection in transplant patients, rheumatoid arthritis, and psoriasis. It is also available as an ophthalmic solution for treating dry eye disease.