TIMOPTIC

LOE Approaching

timolol maleate

Bausch + Lomb

NDAOPHTHALMICSOLUTION/DROPSPriority Review

Approved

Aug 1978

Lifecycle

LOE Approaching

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

Priority Review

TIMOPTIC (timolol maleate) by Bausch + Lomb is components: dorzolamide hydrochloride and timolol maleate. Approved for glaucoma, ocular hypertension. First approved in 1978.

Drug data last refreshed 21h ago · AI intelligence enriched 1w ago

AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data

TIMOPTIC (timolol maleate) is a non-selective beta-adrenergic receptor antagonist ophthalmic solution approved in 1978 for treating glaucoma and ocular hypertension. It reduces intraocular pressure by decreasing aqueous humor secretion, lowering the risk of optic nerve damage and glaucomatous visual field loss. The drug is often used as a monotherapy or in combination with other agents to achieve target IOP reduction.

LOE Approaching

As a mature product approaching loss of exclusivity with moderate competitive pressure (30/100), teams are focused on brand defense and managed transition strategies rather than growth initiatives.

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 (2)

Glaucoma

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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.

Clinical Trials (10)

NCT04830397Phase 2Completed

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

NCT04742283Phase 2Completed

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

NCT03691662Phase 3Completed

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

NCT03691649Phase 3Completed

Started Sep 2018

426 enrolled

Glaucoma and Ocular Hypertension

NCT03519386Phase 3Completed

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

Career Relevance

Working on TIMOPTIC offers stable, established product experience in a well-characterized indication with deep clinical evidence base, but limited growth trajectory or innovation exposure. Roles focus on market defense, payer negotiations, and operational efficiency rather than launch activities or expansion.

Brand ManagerProduct ManagerMedical Science LiaisonField Sales RepresentativeManaged Care Specialist

CommercialMedical AffairsMarket AccessSales

Company

Bausch + Lomb

NJ - Bridgewater

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External Resources

Official Product Website

Patient information & support programs

ClinicalTrials.gov

Active clinical trials for this drug

DailyMed

Full prescribing information