NDAOPHTHALMICSOLUTION/DROPS
Approved
Aug 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
CYSTADROPS (cysteamine hydrochloride) by Recordati is cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides and reduces corneal cystine crystal accumulation. First approved in 2020.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYSTADROPS is a cysteamine hydrochloride ophthalmic solution approved for treating cystinosis, a rare genetic disorder. It works by converting cystine to cysteine and related compounds, reducing harmful cystine crystal accumulation in the cornea. This mechanism directly addresses the underlying pathology of corneal involvement in cystinosis patients.
$0.002BPart D
PeakNiche rare disease product at peak revenue with modest claims volume; commercial team is likely lean and focused on orphan/rare disease market access.
Mechanism of Action
cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides and reduces corneal cystine crystal accumulation.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Cystadrops in Pediatric Cystinosis Patients From Six Months to Less Than Two Years Old (SCOB2)
Started Sep 2020
5 enrolled
Cystinosis
Randomized Study of New Formulation Ophthalmic Cysteamine Hydrochloride for Corneal Cystine Accumulation in Patients With Cystinosis
Started Dec 1999
30 enrolled
Cystinosis
Career Relevance
Working on CYSTADROPS offers deep expertise in rare disease commercialization, ophthalmology, and orphan drug market dynamics. Roles emphasize specialized medical engagement with a small, highly targeted HCP and patient community, with career growth tied to market penetration and real-world outcomes in a niche indication.
Brand Manager
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.