NDAOPHTHALMICSOLUTION/DROPSPriority Review
Approved
Aug 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
10
Data completeness
3/8 — Basic
Priority Review
TIMOPTIC (timolol maleate) by Bausch + Lomb is components: dorzolamide hydrochloride and timolol maleate. First approved in 1978.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIMOPTIC (timolol maleate) is a non-selective beta-adrenergic receptor blocking agent administered as ophthalmic drops to reduce elevated intraocular pressure in glaucoma and ocular hypertension. It works by decreasing aqueous humor secretion in the eye, thereby lowering IOP and reducing the risk of optic nerve damage and glaucomatous field loss. The combination formulation with dorzolamide (a carbonic anhydrase inhibitor) provides additive IOP reduction compared to monotherapy.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30), signaling smaller brand teams and transition planning for generic competition.
Mechanism of Action
components: Dorzolamide hydrochloride and timolol maleate. Each of these two components decreases elevated intraocular pressure, whether or not associated with glaucoma, by reducing aqueous humor secretion. Elevated intraocular pressure is a major risk factor in the pathogenesis of optic nerve…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
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.