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Also known as Bimatoprost Ophthalmic Solution, 0.01%
Bimatoprost, 0.01% · 1 trial · 2 indications
Mean difference in the IOP of both eyes between the two treatment groups at 3 time points
| Arm | Type | Description |
|---|---|---|
| Bimatoprost Ophthalmic Solution, 0.01% | EXPERIMENTAL | Test Product: Bimatoprost Ophthalmic Solution, 0.01% |
| LUMIGAN® (bimatoprost ophthalmic solution) 0.01% | ACTIVE_COMPARATOR | Reference Product: LUMIGAN® (bimatoprost ophthalmic solution) 0.01% |
| Name | Type | Description |
|---|---|---|
| Bimatoprost Ophthalmic Solution, 0.01% | DRUG | 1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule. |
| LUMIGAN® (bimatoprost ophthalmic solution) 0.01% | DRUG | 1 drop of ophthalmic solution instill in both eyes every night at 10:00 pm (±1 hours) for 42 days (6 weeks) (± 4 days) as per the randomization schedule. |
Inclusion Criteria: 1. Subjects willing and able to provide voluntary informed consent and to follow protocol requirements. 2. Male or females aged ≥18 years. 3. Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes 4. Subjects requiring treatment of both eyes and able to di...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 3 | PHASE4 | Travoprost Intraocular |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE4 | Test - Bimatoprost 0.01%, Reference - LUMIGAN |
| AbbVie, Inc. | ABBV | 1 | PHASE4 | Bimatoprost |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Nicotinomide |
| Alcon AG | ALC | 3 | PHASE4 | Undisclosed |
Bimatoprost, 0.01% is an ophthalmic solution used for the treatment of open-angle glaucoma. It is being studied in patients with chronic open-angle glaucoma or ocular hypertension in both eyes. The drug is administered as eye drops and is currently in clinical development for this indication.
Bimatoprost, 0.01% is being developed by Amneal Pharmaceuticals, Inc., a company traded on the New York Stock Exchange under the ticker symbol AMRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating open-angle glaucoma.
Bimatoprost, 0.01% is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing trial is a randomized, double-blind, parallel-group study with an active control, designed to assess bioequivalence in patients with open-angle glaucoma.
Bimatoprost, 0.01% is being evaluated in a single clinical trial registered as NCT06267274. This Phase 1 study is a randomized, double-blind, parallel-group, two-arm, multiple-dose, multicenter bioequivalence study with a clinical endpoint. The trial enrolls 240 participants in the United States and includes patients aged 18 years and older.
Yes, Bimatoprost, 0.01% is the same as Bimatoprost Ophthalmic Solution, 0.01%. These names refer to the identical drug product being developed by Amneal Pharmaceuticals. The drug is a small molecule administered as an ophthalmic solution for the treatment of open-angle glaucoma.