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Nebivolol 1 Percent · 1 trial · 2 indications
Measured utilizing a calibrated Goldmann tonometer; two consecutive IOP measurements of each eye will be performed. If the 2 measurements differ by more than 2 mm Hg, a third measurement will be taken. The primary efficacy analysis will be the between-group comparison of the mean IOP values in the study eye at 10AM, 2 hours postdose, and 4PM, at each of the Visit 4/Day 15, Visit 5/Day 42, and Visit 6/Day 84 visits (ie, a total of 9 between-group comparisons). A hierarchical analysis will be conducted to compare each of the investigational products against the comparator, timolol 0.5% ophthalmic solution, as follows: (1) nebivolol 1% ophthalmic suspension, (2) nebivolol 0.5% ophthalmic suspension, and (3) timolol ophthalmic suspension.
| Arm | Type | Description |
|---|---|---|
| Nebivolol Ophthalmic Suspension 1 Percent | EXPERIMENTAL | Administered twice daily to both eyes for 84 days (12 weeks) |
| Nebivolol Ophthalmic Suspension 0.5 Percent | EXPERIMENTAL | Administered twice daily to both eyes for 84 days (12 weeks) |
| Timolol Ophthalmic Suspension 0.5 Percent | EXPERIMENTAL | Administered twice daily to both eyes for 84 days (12 weeks) |
| Timolol Ophthalmic Solution 0.5 Percent | ACTIVE_COMPARATOR | Administered twice daily to both eyes for 84 days (12 weeks) |
| Name | Type | Description |
|---|---|---|
| Nebivolol Ophthalmic Suspension 1 Percent | DRUG | 1 drop instilled into each eye twice daily |
| Nebivolol Ophthalmic Suspension 0.5 Percent | DRUG | 1 drop instilled into each eye twice daily |
| Timolol Ophthalmic Suspension 0.5 Percent | DRUG | 1 drop instilled into each eye twice daily |
| Timolol Ophthalmic Solution 0.5 Percent | DRUG | 1 drop instilled into each eye twice daily |
Inclusion Criteria: 1. Willing and able to understand and sign an informed consent form prior to any study related procedures. 2. Able to administer or have a caregiver accurately administer an eye drop. 3. Have POAG or OHT in both eyes that requires therapy for IOP and is adequately controlled, in...
| 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 |
Nebivolol 1 Percent is an investigational small molecule being developed for the treatment of open-angle glaucoma and ocular hypertension. It is a topical ophthalmic formulation intended to lower intraocular pressure in patients with these conditions. The drug is currently in Phase 2 clinical development.
Nebivolol 1 Percent is a beta-blocker, a class of drugs that works by blocking beta-adrenergic receptors. In the eye, this reduces the production of aqueous humor, thereby lowering intraocular pressure. This mechanism is relevant for treating open-angle glaucoma and ocular hypertension.
Nebivolol 1 Percent is being developed by Summit Therapeutics Inc., a biopharmaceutical company. Summit Therapeutics is publicly traded under the ticker symbol SMMT on the stock market.
Nebivolol 1 Percent is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its safety and efficacy in patients with open-angle glaucoma and ocular hypertension.
Nebivolol 1 Percent has been studied in a completed Phase 2 clinical trial with the identifier NCT04910100. This trial compared Nebivolol 0.5% and 1.0% suspensions to Timolol 0.5% solution in 226 patients with open-angle glaucoma or ocular hypertension. The study was conducted in the United States.
No, Nebivolol 1 Percent is not the same as Timolol. Nebivolol is a distinct beta-blocker being developed by Summit Therapeutics, while Timolol is an established beta-blocker used as a comparator in clinical trials. In the Phase 2 trial, Nebivolol was compared directly against Timolol 0.5% solution.