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Also known as Test - Bimatoprost 0.01% Ophthalmic Solution
Test- Bimatoprost 0.01% · 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...
Test- Bimatoprost 0.01% is an ophthalmic solution used for the treatment of glaucoma and open-angle glaucoma. It is being developed as a small molecule therapy for these conditions, which affect the eye and can lead to vision loss if untreated.
Test- Bimatoprost 0.01% is a small molecule ophthalmic solution. Its specific molecular target is not disclosed in the available information, so its mechanism of action is not detailed here.
Test- Bimatoprost 0.01% is being developed by Amneal Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker symbol AMRX. The company is conducting clinical trials for this ophthalmic solution.
Test- Bimatoprost 0.01% is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants.
Test- Bimatoprost 0.01% is being studied in a Phase 3 clinical trial with the identifier NCT05401357. This trial is a bioequivalence study comparing Bimatoprost Ophthalmic Solution 0.01% to LUMIGAN in patients with chronic open-angle glaucoma or ocular hypertension.
Yes, Test- Bimatoprost 0.01% is also known as Test - Bimatoprost 0.01% Ophthalmic Solution. These names refer to the same investigational drug product being developed by Amneal Pharmaceuticals.