Recordati Rare Diseases’ Cystadrops (Cysteamine Ophthalmic Solution) Receives the US FDA’s Approval for the Treatment of Ocular Manifestations of Cystinosis

Shots:

• The approval is based on two clinical trials, a P-III study (n=15) and a P-I/IIa study (n=8) assessing Cystadrops at a median frequency of four times per day
• Result: P-III study showed 40 % reduction in the IVCM total score across all corneal layers from baseline to 90 days and P-I/IIa study demonstrated a 30 % decrease in IVCM total score that was maintained for the 5 year study period
• Cystadrops (cysteamine ophthalmic solution) 0.37% is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis. It is the 1st and only FDA-approved cysteamine eye drop formulation

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