Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AGN-210669 · 2 trials · 2 indications
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).
| Arm | Type | Description |
|---|---|---|
| AGN-210669 | EXPERIMENTAL | AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1. |
| AGN-210669 + bimatoprost | EXPERIMENTAL | AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| AGN-210669 + bimatoprost vehicle | EXPERIMENTAL | AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| bimatoprost | ACTIVE_COMPARATOR | bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1. |
| bimatoprost + AGN-210669 | EXPERIMENTAL | bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| bimatoprost + bimatoprost vehicle | OTHER | bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| AGN-210669 ophthalmic solution, 0.1% | EXPERIMENTAL | One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| AGN-210669 ophthalmic solution, 0.075% | EXPERIMENTAL | One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| AGN-210669 ophthalmic solution, 0.05% | EXPERIMENTAL | One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| bimatoprost ophthalmic solution 0.03% | ACTIVE_COMPARATOR | One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| Name | Type | Description |
|---|---|---|
| AGN-210669 | DRUG | AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2. |
| bimatoprost | DRUG | bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2. |
| bimatoprost vehicle | DRUG | bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2. |
| AGN-210669 ophthalmic solution, 0.1% | DRUG | One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| AGN-210669 ophthalmic solution, 0.075% | DRUG | One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| AGN-210669 ophthalmic solution, 0.05% | DRUG | One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| bimatoprost ophthalmic solution 0.03% | DRUG | One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
Inclusion Criteria: * Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye * Requires bilateral treatment with an IOP-lowering medication * Best corrected visual acuity of 20/100 or better in each eye Exclusion Criteria: * Use of oral, intramuscular, intravenous or topical ...
AGN-210669 is an investigational small molecule being developed by AbbVie Inc. for the treatment of ocular hypertension, glaucoma, and open-angle glaucoma. It is formulated as an ophthalmic solution for topical administration to the eye. The drug has been evaluated in clinical trials in the United States.
AGN-210669 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The drug is an investigational small molecule ophthalmic solution intended for the treatment of ocular hypertension and glaucoma.
AGN-210669 is in Phase 2 clinical development. The drug has completed two Phase 2 trials and one Phase 1 trial, all of which are finished. AGN-210669 remains investigational and has not been approved by regulatory authorities for commercial use.
AGN-210669 has been studied in three completed clinical trials in the United States. NCT00809848 was a Phase 1 trial with 172 participants. NCT01001195 and NCT01291108 were Phase 2 trials with 165 and 125 participants, respectively. All trials enrolled adults aged 18 years and older.
Two Phase 2 trials of AGN-210669 were active-controlled studies comparing the drug to bimatoprost ophthalmic solution. NCT01001195 evaluated three formulations of AGN-210669 against bimatoprost, and NCT01291108 compared AGN-210669 with bimatoprost in patients with open-angle glaucoma or ocular hypertension.