Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AGN-210961 Formulation 1, AGN-210961 Formulation 2, AGN-210961 Formulation 3, AGN-210961 Formulation 4, AGN-210961 Formulation 5, AGN-210961 Formulation 6, AGN-210961 Formulation 7
AGN-210961 · 1 trial · 2 indications
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 |
|---|---|---|---|---|
| SpyGlass Pharma, Inc. | SGP | 5 | PHASE3 | Bimatoprost System, BIM-DRS |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE3 | Bimatoprost ophthalmic solution |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | AGN-193408 |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE1 | REGN22530 |
| Glaukos Corp | GKOS | 2 | - | Travoprost |
AGN-210961 is an investigational ophthalmic small molecule being studied for ocular hypertension, with a Phase 2 trial also enrolling patients with primary open-angle glaucoma. It is being developed by AbbVie Inc. as a topical eye drop formulation intended to lower intraocular pressure in these conditions.
AGN-210961 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating this ophthalmic small molecule for ocular hypertension and primary open-angle glaucoma.
AGN-210961 is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA for any indication.
AGN-210961 has been evaluated in one completed Phase 2 trial, NCT01110499, titled a study of AGN-210961 ophthalmic solution compared with bimatoprost ophthalmic solution in patients with glaucoma or ocular hypertension. The randomized, double-blind, active-controlled trial enrolled 163 patients across sites in the United States.
Yes. AGN-210961 Formulation 1, Formulation 2, Formulation 3, Formulation 4, Formulation 5, Formulation 6, and Formulation 7 are all alternative names for AGN-210961, the ophthalmic small molecule developed by AbbVie for ocular hypertension. These formulation labels refer to the same investigational drug asset.
The Phase 2 trial of AGN-210961, NCT01110499, enrolled 163 patients. It was a randomized, double-blind, active-controlled study comparing AGN-210961 ophthalmic solution with bimatoprost ophthalmic solution in adults with ocular hypertension or primary open-angle glaucoma.