Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01110499 | Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension | PHASE2 | COMPLETED | 163 | — | — | Jun 1, 2010 | Jun 1, 2011 | Aug 5, 2014 | 1 | United States |
IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.
IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.
| Arm | Type | Description |
|---|---|---|
| Part 1, AGN-210961 Formulation 1 | EXPERIMENTAL | AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| Part 1, AGN-210961 Formulation 2 | EXPERIMENTAL | AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| Part 1, AGN-210961 Formulation 3 | EXPERIMENTAL | AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| Part 1, AGN-210961 Formulation 4 | EXPERIMENTAL | AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| Part 1, AGN-210961 Formulation 5 | EXPERIMENTAL | AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| Part 1, AGN-210961 Formulation 6 | EXPERIMENTAL | AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days. |
| Part 2, AGN-210961 Formulation 7 | EXPERIMENTAL | AGN-210961 Formulation 7 in both eyes once daily for 4 weeks. |
| Part 2, bimatoprost ophthalmic solution 0.03% | ACTIVE_COMPARATOR | bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| AGN-210961 Formulation 1 | DRUG | AGN-210961 Formulation 1 in one eye once daily for 7 days. |
| AGN-210961 Formulation 2 | DRUG | AGN-210961 Formulation 2 in one eye once daily for 7 days. |
| AGN-210961 Formulation 3 | DRUG | AGN-210961 Formulation 3 in one eye once daily for 7 days. |
| AGN-210961 Formulation 4 | DRUG | AGN-210961 Formulation 4 in one eye once daily for 7 days. |
| AGN-210961 Formulation 5 | DRUG | AGN-210961 Formulation 5 in one eye once daily for 7 days. |
| AGN-210961 Formulation 6 | DRUG | AGN-210961 Formulation 6 in one eye once daily for 7 days. |
| AGN-210961 Formulation 7 | DRUG | AGN-210961 Formulation 7 in both eyes once daily for 4 weeks. |
| bimatoprost ophthalmic solution 0.03% | DRUG | bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks. |
Inclusion Criteria: \- Ocular hypertension or primary open-angle glaucoma in each eye Exclusion Criteria: * Any active ocular disease * Anticipated wearing of contact lenses during study * Anticipated use of artificial tears during study * Contraindication to pupil dilatation
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Bimatoprost, AGN-193408 |
| SpyGlass Pharma, Inc. | SGP | 4 | PHASE3 | Bimatoprost System, Timolol , 0.5% |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 2 | PHASE3 | Test - Bimatoprost 0.01%, Reference - LUMIGAN, Bimatoprost , 0.01%, LUMIGAN 0.01% |
| Glaukos Corp | GKOS | 1 | — | Travoprost |