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

 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

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Recordati Rare Disease

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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