Cystadrops approved for treatment of ocular manifestations of cystinosis
The FDA has approved Cystadrops, a viscous eye drop solution that reduces corneal cystine crystal deposits in patients with cystinosis, according to a press release from Recordati Rare Diseases.
Approval of Cystadrops (cysteamine ophthalmic solution 0.37%), which is applied four times a day, was supported by data from two clinical trials. In a phase 3 open-label, randomized, controlled, two-arm multicenter trial, 15 patients treated with the formulation experienced a 40% reduction in corneal cystine crystal density as assessed by in vivo confocal microscopy from baseline to 90 days.
The most common adverse effects of the drops were stinging, blurred vision, eye irritation, eye redness, application site discomfort, eye itching, watery eyes and medicine deposit around the eyes.
“Cystinosis is a complex disease, and early detection and prompt treatment are critical in slowing the development and progression of symptoms. Improvements in the treatment of cystinosis in the last few decades has led to increased life expectancies. Despite these advances, eye manifestations of the disease are a continual struggle for patients,” Clinton Moore, president of the Cystinosis Research Network, said in the release. “Cystinosis patients live with sensitivity to light, eye discomfort and pain. They often wear sunglasses even when indoors and fight to keep up with daily activities like school and work.”