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.
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