NDAOPHTHALMICSOLUTION/DROPSPriority Review
Approved
Oct 2012
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
CYSTARAN (cysteamine hydrochloride) by Leadiant Biosciences is cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides and reduces corneal cystine crystal accumulation. First approved in 2012.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYSTARAN is a cysteamine hydrochloride ophthalmic solution approved in 2012 for treating corneal cystine crystal accumulation in cystinosis patients. It works by converting cystine to cysteine and mixed disulfides, reducing crystal deposition in the cornea and preserving vision. This is a rare disease therapy addressing a critical unmet need in a small, well-defined patient population.
$0.002BPart D
PeakStable
At peak lifecycle with modest Part D spending ($2M in 2023) and 233 claims, indicating a stable but niche market suitable for specialized commercial teams focused on rare disease management.
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 (1)
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 CYSTARAN offers niche expertise in rare ophthalmic diseases and specialized patient management within a stable, peak-stage product. Career growth depends on mastery of rare disease commercial execution, payer relationships, and patient registry management rather than traditional pipeline advancement.
Rare Disease Specialist
Worked on CYSTARAN at Leadiant Biosciences? Share your interview experience or compensation data (+7 days Pro)
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.