Recordati Rare Diseases announced that Cystadrops (cysteamine ophthalmic solution) 0.37% is now available for prescription and distribution across the United States. Cystadrops is a new, viscous eye drop solution that depletes cystine crystal deposits in the cornea of the eyes of people living with cystinosis. Cystinosis is a rare genetic condition present from birth that leads to the build-up of cystine crystals throughout the body, causing widespread tissue and organ damage and significant impact on the eyes.
Cystadrops is available exclusively through Anovo, a specialty pharmacy that focuses on providing medical treatments to people living with rare and chronic diseases. Recordati and Anovo have partnered together to establish patient support services including insurance benefit investigations, educational references, resources for financial aid, and more. Clinicians can complete a prescription form here.
Cystadrops is the first and only FDA-approved cysteamine eye drop formulation with four times a day dosing. The FDA approval of Cystadrops was supported by data from two clinical trials, both in which patients received Cystadrops at a median frequency of four times per day. A phase 3 open-label, randomized, controlled, two-arm multicenter trial, with 15 patients in the Cystadrops arm, investigated the reduction in corneal cystine crystal density as assessed by in vivo confocal microscopy (IVCM). In the Cystadrops arm, the trial showed a 40 percent reduction in the IVCM total score across all corneal layers from baseline to 90 days.
A phase 1/2a open-label, adaptive dose-response clinical trial of eight cystinosis patients showed that treatment with Cystadrops resulted in a 30 percent decrease in IVCM total score that was maintained for the five-year study period.
The safety of Cystadrops was evaluated in two clinical trials. The most commonly observed adverse reactions were eye pain (stinging), blurred vision, eye irritation (burning), eye redness, discomfort at instillation site (sticky eyes or sticky eyelids), eye itching, watery eyes, and medicine deposit on the eye lashes or around the eyes.
Click here for full Prescribing Information and Instructions For Use.