With the FDA's approval last week of cyclosporine ophthalmic emulsion 0.1% (Verkazia), ophthalmologists now have another option to treat their patients, both adults and children, with vernal keratoconjunctivitis (VKC), an allergic eye condition that if left untreated can lead to corneal shield ulcers and potentially vision loss.
The therapy, which will be available by prescription only, comes in an oil-in-water cationic emulsion. It offers improved ocular bioavailability of cyclosporine, according to Santen Inc, the manufacturer.
The therapy inhibits T-cell activation and decreases the level of immune cells and mediators that lead to allergic inflammation of the ocular surface.
The treatment was assessed in two randomized, multicenter, double-masked, vehicle-controlled clinical trials: the VEKTIS study and the NOVATIVE study.
A press release issued by the manufacturer described the study details: in the VEKTIS study, patients with severe VKC were randomly assigned to receive Verkazia 1 mg/mL four times daily or two times daily and vehicle group for the first 4 months (period 1).
The NOVATIVE study involved patients with moderate to severe VKC who were randomly assigned to receive Verkazia 1 mg/mL four times daily or cyclosporine ophthalmic emulsion 0.5 mg/mL four times daily and vehicle group for the first month (period 1).
