NDATOPICALFOR SOLUTIONPriority Review
Approved
Feb 2012
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 1m ago · AI intelligence enriched 1m ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MITOSOL is a topical mitomycin formulation approved in 2012 for ophthalmic use, specifically to reduce corneal haze and scarring in patients undergoing refractive surgery. Mitomycin is an antiproliferative agent that inhibits fibroblast proliferation, preventing excessive tissue remodeling post-operatively. This niche indication positions it within ophthalmology and surgical support categories.
LOE Approaching2.7 years to LOE
Product faces patent expiry in 2.7 years with moderate competitive pressure (30/100); expect downsizing or strategic repositioning of commercial teams.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
Started Sep 2022
201 enrolled
Colorectal CancerChemotherapy EffectSurgery+2 more
Safety and Efficacy of an Ab Interno Gelatin Stent (XEN63) With or Without Mitomycin C
Started Nov 2020
30 enrolled
Glaucoma, Open-Angle
Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement
Started Jun 2019
142 enrolled
Glaucoma
Comparing Preoperative Injection of Mitomycin-C vs. Intraoperative Injection of Mitomycin-C vs. Topical Application of Mitomycin-C (Conventional Use) in Trabeculectomy
Started Mar 2019
19 enrolled
Glaucoma Open-Angle PrimaryGlaucomaOpen Angle Glaucoma+1 more
A Study of Mitomycin-c/ Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study
Started Jan 2019
50 enrolled
Urinary Bladder CancerInvasive Bladder Cancer
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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.