Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Top 3 of 5 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 3 | PHASE4 | Travoprost Intraocular, high elution |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE4 | Bimatoprost ophthalmic solution |
| AbbVie, Inc. | ABBV | 1 | PHASE4 | bimatoprost |