NDAOPHTHALMICSOLUTION, GEL FORMING/DROPS2 Generics Approved
Approved
Oct 1998
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
9
Data completeness
2/8 — Basic
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Timolol maleate is a non-selective beta-blocker ophthalmic solution approved for topical eye use. It reduces intraocular pressure in glaucoma and ocular hypertension patients by decreasing aqueous humor production. This small-molecule therapy is a foundational treatment in ophthalmology with decades of clinical validation.
LOE Approaching
Mature product approaching loss of exclusivity with moderate competitive pressure (60%) signals defensive positioning and potential team consolidation.
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 (9)
Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).
Started Mar 2021
84 enrolled
Primary Open Angle GlaucomaOcular Hypertension
Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Started Dec 2020
323 enrolled
Primary Open Angle GlaucomaOcular Hypertension
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study
Started Sep 2018
417 enrolled
Glaucoma and Ocular Hypertension
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 3 Study
Started Sep 2018
426 enrolled
Glaucoma and Ocular Hypertension
Randomized Study Comparing Two Models of a Travoprost Intraocular Implant to Timolol Maleate Ophthalmic Solution, 0.5%
Started Jul 2018
590 enrolled
Glaucoma, Open-AngleOcular Hypertension
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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.