Posted by Michael Wonder on 28 Aug 2020
U.S. FDA approves Cystadrops (0.37% cysteamine ophthalmic solution), a new practical treatment option for the ocular manifestations of cystinosis
25 August 2020 - Recordati Rare Diseases today announced the U.S. FDA has approved Cystadrops (0.37% cysteamine ophthalmic solution).
Cystadrops is a new, viscous eye drop solution that depletes corneal cystine crystal deposits in people living with cystinosis. Cystadrops demonstrated a significant reduction in cystine crystal deposits in the cornea of the eye and is the first and only FDA-approved cysteamine 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.
