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 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYSTARAN (cysteamine hydrochloride) is an ophthalmic solution that depletes corneal cystine by converting cystine to cysteine and mixed disulfides, reducing crystal accumulation. It is indicated for patients with cystinosis, a rare genetic disorder causing cystine accumulation in the cornea and other tissues. This is the only FDA-approved topical therapy specifically targeting corneal manifestations of cystinosis.
$0.002BPart D
PeakStable
dominant position in cystinosis corneal treatment (rare disease niche)
At peak lifecycle with modest Part D spending ($2M, 233 claims in 2023), this rare-disease product maintains stable commercial operations with a specialized, small commercial team focused on high-touch patient support.
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
CYSTARAN offers a niche, specialized career path in rare ophthalmology with emphasis on deep patient relationships, high-touch customer engagement, and reimbursement expertise rather than broad-market sales volume. Roles on this team benefit from stability, small-team agility, and focused clinical expertise in a high-need, underserved patient population.
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.