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brinzolamide 1%

Phase 3

Glaucoma | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: May 9, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment895

FDA Designations

No designations recorded

Clinical trial landscape

brinzolamide 1% · 2 trials · 2 indications

Phase 3 1Phase 1 1
NCT01722604Therapeutic Equivalence Study of Generic Brinzolamide vs AzoptGlaucoma
COMPLETED258 Analytics
PHASE3COMPLETED
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Intraocular Pressure (IOP) at Week 12
Week 12
Intraocular Pressure (IOP)
6 weeks

Secondary Endpoints

Change in Intraocular Pressure (IOP) From Baseline to Week 12
Baseline, Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH

Treatment Arms

ArmTypeDescription
Azopt 1% ophthalmic suspensionACTIVE_COMPARATOROphthalmic suspension
Brinzolamide 1% ophthalmic suspensionEXPERIMENTALophthalmic suspension

Interventions

NameTypeDescription
brinzolamide 1% ophthalmic suspensionDRUGbrinzolamide 1% ophthalmic suspension
Azopt 1%DRUGAzopt 1%, RLD
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and females 18 years of age or older, * diagnosed with primary open-angle glaucoma or ocular hypertension. Exclusion Criteria: * Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye...

Countries:United States
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Frequently asked questions about brinzolamide 1%

What is brinzolamide 1% used for?

Brinzolamide 1% is used for the treatment of glaucoma, specifically open-angle glaucoma or ocular hypertension. It is an ophthalmic solution developed by Bausch + Lomb Corporation. The drug is a small molecule administered as eye drops to help lower intraocular pressure in patients with these conditions.

Who makes brinzolamide 1%?

Brinzolamide 1% is developed by Bausch + Lomb Corporation, a company listed on the stock exchange under the ticker BLCO. The company is conducting clinical trials to evaluate the therapeutic equivalence of generic brinzolamide compared to the reference product Azopt in patients with glaucoma.

What phase is brinzolamide 1% in?

Brinzolamide 1% is in Phase 3 clinical development for glaucoma. One completed Phase 3 trial (NCT01722604) evaluated its therapeutic equivalence to Azopt in 258 patients. Another completed Phase 1 trial (NCT03896633) enrolled 637 participants. The drug remains investigational and is not yet approved.

What clinical trials is brinzolamide 1% in?

Brinzolamide 1% has two completed clinical trials. NCT01722604 is a Phase 3 study with 258 participants, and NCT03896633 is a Phase 1 study with 637 participants. Both trials assessed therapeutic equivalence of generic brinzolamide versus Azopt in patients with open-angle glaucoma or ocular hypertension in the United States.

How does brinzolamide 1% work?

Brinzolamide 1% works by inhibiting the enzyme carbonic anhydrase, which reduces the production of aqueous humor in the eye, thereby lowering intraocular pressure. This mechanism helps manage glaucoma and ocular hypertension by decreasing fluid buildup that can damage the optic nerve.

Is brinzolamide 1% the same as Azopt?

Brinzolamide 1% is being studied as a generic version of Azopt. Clinical trials are designed to demonstrate therapeutic equivalence between the generic brinzolamide formulation and Azopt, the reference product. Both contain the same active ingredient, brinzolamide, at a 1% concentration.