Approval Probability
TA Base Rate
Adjusted LOA
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Also known as AGN-210669 ophthalmic solution, 0.075%, AGN-210669, AGN-210669 ophthalmic solution, 0.1%, AGN-210669, 0.1%
AGN-210669, 0.075% · 3 trials · 3 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. |
| AGN-210669 ophthalmic solution, 0.025% | EXPERIMENTAL | AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. |
| AGN-210669 vehicle ophthalmic solution | PLACEBO_COMPARATOR | AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks. |
| 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. |
| AGN-210669 ophthalmic solution, 0.025% | DRUG | AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks. |
| AGN-210669 vehicle ophthalmic solution | DRUG | AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks. |
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, 0.075% is an investigational ophthalmic solution being studied for open-angle glaucoma and ocular hypertension. It is a small molecule eye drop developed by AbbVie Inc. (ABBV). The 0.075% strength is one of several concentrations evaluated in clinical trials comparing it with bimatoprost ophthalmic solution.
AGN-210669, 0.075% is being 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 solution in patients with open-angle glaucoma or ocular hypertension.
AGN-210669, 0.075% is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Two Phase 2 trials and one Phase 1 trial have been completed, and no trials are currently active. The program enrolled 290 patients in total across randomized, double-blind, active-controlled studies.
AGN-210669, 0.075% has been studied in completed trials including NCT01291108, a Phase 2 trial in 125 patients with open-angle glaucoma or ocular hypertension, and NCT01001195, a Phase 2 trial in 165 patients comparing three formulations against bimatoprost ophthalmic solution. Both were conducted in the United States.
AGN-210669, 0.075% and AGN-210669 ophthalmic solution, 0.1% are different concentration strengths of the same investigational compound, AGN-210669. Both are ophthalmic solutions developed by AbbVie for open-angle glaucoma and ocular hypertension, and both strengths were evaluated in the Phase 2 clinical program.