The Food and Drug Administration (FDA) has approved Verkazia™ (cyclosporine ophthalmic emulsion) 0.1% for the treatment of vernal keratoconjunctivitis in children and adults.
Vernal keratoconjunctivitis is a rare allergic eye disease that results in severe inflammation of the surface of the eye. Verkazia is an oil-in-water cationic emulsion that works by inhibiting T-cell activation and reducing the level of immune cells and mediators.
The approval was based on data from 2 randomized, multicenter, double-masked, vehicle-controlled trials, VEKTIS (ClinicalTrials.gov Identifier: NCT01751126) and NOVATIVE (ClinicalTrials.gov Identifier: NCT00328653), which evaluated the efficacy and safety of Verkazia in patients with severe vernal keratoconjunctivitis or moderate to severe vernal keratoconjunctivitis, respectively.
In the VEKTIS trial, 169 patients were randomly assigned to receive Verkazia 1mg/mL 4 times daily (high-dose), or 2 times daily plus vehicle 2 times daily (low-dose), or vehicle 4 times daily for the first 4 months, followed by Verkazia 2 or 4 times daily for the next 8 months. In the NOVATIVE trial, 114 patients were randomly assigned to receive Verkazia 1mg/mL 4 times daily, cyclosporine 0.5mg/mL and vehicle 4 times daily for the first month, followed by cyclosporine 0.5 mg/mL 4 times daily or Verkazia 1mg/mL 4 times daily for the next 3 months.
Results from both trials showed that treatment with Verkazia improved inflammation of the cornea (keratitis score) and ocular itching. The most common adverse reactions reported were eye pain (12%) and eye pruritus (8%), which were usually transitory and occurred during instillation.
“If left untreated, [vernal keratoconjunctivitis] 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,” said Tatsuya Kaihara, CEO of Santen Inc. and Head of Santen North America. “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.”
Santen receives FDA approval for Verkazia™ (cyclosporine ophthalmic emulsion) 0.1% for the treatment of vernal keratoconjunctivitis in children and adults. [press release]. Emeryville, CA: Santen Inc.; June 24, 2021.