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 Yesterday · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYSTADROPS is a cysteamine hydrochloride ophthalmic solution approved in 2020 for treating cystinosis, a rare genetic disorder causing cystine crystal accumulation in the cornea. It works by converting cystine to cysteine and cysteine-cysteamine mixed disulfides, thereby reducing corneal crystal buildup and preserving vision. This is the first and only topical treatment specifically designed for corneal cystinosis.
$0.002BPart D
Peak100% of topical corneal cystinosis market (monopoly)
Peak lifecycle phase with modest Part D penetration ($2M annually, 263 claims in 2023) suggests a niche, specialized commercial team focused on rare disease awareness and patient 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 positions you in a high-impact rare disease franchise with a monopoly market position and deep relationships with cystinosis specialists and patient advocacy groups. The modest commercial scale ($2M annual spending) suggests a highly specialized, expert-driven team rather than a mass-market sales force.
Rare Disease Specialist
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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.