Cystadrops® (cysteamine ophthalmic solution) 0.37% has been made available by Recordati Rare Diseases for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.
Cystinosis is a rare, multisystem genetic disorder caused by an accumulation of cystine crystals throughout the body, including the eyes. Cysteamine is a cystine-depleting agent that converts cystine to cysteine and cysteine-cysteamine mixed disulfides, thereby reducing cystine crystal accumulation.
Cystadrops is supplied as 3.8mg/mL of cysteamine (equivalent to 5.6mg/mL of cysteamine hydrochloride) in a 5mL sterile viscous solution. The product requires refrigeration if unopened. Upon opening, it should be stored at room temperature and discarded after 7 days.
The Food and Drug Administration (FDA) approved Cystadrops in August 2020 based on data from a randomized controlled study conducted over 90 days and a single-arm study conducted for 5 years. Findings from both studies showed that treatment with Cystadrops was associated with a reduction in corneal cystine crystal deposits based on in vivo confocal microscopy total score.
The most common adverse reactions reported with Cystadrops use include eye pain, blurred vision, eye irritation, ocular hyperemia, instillation site discomfort, eye pruritus, increased lacrimation, and ocular deposits. Contact lenses should be removed prior to application of Cystadrops and may be reinserted 15 minutes following its administration.
Cystadrops is available exclusively through Anovo, a specialty pharmacy. A prescription order form for the product can be found here.
For more information visit cystadrops.com.
- Recordati Rare Diseases announces availability of Cystadrops® (cysteamine ophthalmic solution) 0.37% in the US. https://www.prnewswire.com/news-releases/recordati-rare-diseases-announces-availability-of-cystadrops-cysteamine-ophthalmic-solution-0-37-in-the-us-301130690.html. Accessed September 16, 2020.
- Cystadrops [package insert]. Lebanon, NJ: Recordati Rare Diseases Inc; 2020.