NDAOPHTHALMICSOLUTION/DROPS
Approved
Aug 2020
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
5/8 — 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. Approved for cystinosis. First approved in 2020.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYSTADROPS is a cysteamine hydrochloride ophthalmic solution approved in 2020 for cystinosis, a rare autosomal recessive lysosomal storage disorder. The drug works as a cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides, reducing corneal cystine crystal accumulation and associated photophobia. It represents a localized ophthalmologic treatment for a systemic metabolic disease.
$0.002BPart D
PeakProduct is in peak lifecycle phase with modest spending of $2M annually, suggesting a small specialist team focused on rare disease market penetration.
Mechanism of Action
cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides and reduces corneal cystine crystal accumulation.
Indications (1)
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
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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.