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Also known as Test - Bimatoprost 0.01% Ophthalmic Solution, Test- Bimatoprost 0.01%
Bimatoprost ophthalmic solution · 1 trial · 2 indications
Change in mean difference in the intraocular pressure (IOP) of both eyes between the two treatment groups at six time points, i.e., at 00.00 hour, 04.00 hours, and 08.00 hours at Day 14 (Week 2) and Day 42 (Week 6) visits
| Arm | Type | Description |
|---|---|---|
| Bimatoprost 0.01% Ophthalmic Solution | EXPERIMENTAL | Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc. |
| LUMIGAN® 0.01% Ophthalmic Solution | ACTIVE_COMPARATOR | Pharmaceutical dosage form contains LUMIGAN® (bimatoprost ophthalmic solution) 0.01% of Allergan, Inc. |
| Name | Type | Description |
|---|---|---|
| Test - Bimatoprost 0.01% Ophthalmic Solution | DRUG | Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 1 hour for 42 days. |
| Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) | DRUG | Subjects in the other arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm for 42 days. |
Inclusion Criteria: * Subjects willing and able to provide voluntary informed consent and to follow protocol requirements. * Male or females aged ≥18 years. * Subjects having body mass index (BMI) ≥18.50 kg/m2. * Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. * Subje...
Bimatoprost, 0.01% is an investigational small molecule being developed for the treatment of chronic open-angle glaucoma and ocular hypertension. It is administered as an eye drop and is currently being studied in a Phase 1 clinical trial to evaluate its bioequivalence and efficacy in patients with these conditions.
Bimatoprost, 0.01% is a prostaglandin analog that works by increasing the outflow of aqueous humor from the eye, thereby reducing intraocular pressure. This mechanism helps to lower pressure in patients with open-angle glaucoma or ocular hypertension, potentially slowing disease progression.
Bimatoprost, 0.01% is being developed by Amneal Pharmaceuticals, Inc., a company traded on the NYSE under the ticker symbol AMRX. The company is conducting a Phase 1 clinical trial to assess the drug's bioequivalence and safety in patients with open-angle glaucoma.
Bimatoprost, 0.01% is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing trial is designed to evaluate its bioequivalence and clinical effects in patients with open-angle glaucoma or ocular hypertension.
Bimatoprost, 0.01% is being studied in a single Phase 1 clinical trial registered as NCT06267274. This randomized, double-blind, parallel-group, active-controlled study is enrolling 240 participants in the United States to assess the drug's bioequivalence and efficacy in treating chronic open-angle glaucoma or ocular hypertension.
Bimatoprost, 0.01% is a specific low-concentration formulation of the drug bimatoprost. While bimatoprost is the active pharmaceutical ingredient, the 0.01% concentration is being specifically developed and tested by Amneal Pharmaceuticals for its potential use in treating open-angle glaucoma and ocular hypertension.