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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04499248 | AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension | PHASE1 | ACTIVE NOT_RECRUITING | 100 | — | — | Nov 16, 2020 | Apr 1, 2029 | May 22, 2026 | 49 | United States, Japan |
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 -Dose A | EXPERIMENTAL | Single dose of AGN-193408 SR Dose A administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1. |
| Cohort 1 - Dose B | EXPERIMENTAL | Single dose of AGN-193408 SR Dose B administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1. |
| Cohort 2 - Dose A | EXPERIMENTAL | AGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye. |
| Cohort 2 - Dose B | EXPERIMENTAL | AGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye. |
| Cohort 3 - Dose A | EXPERIMENTAL | AGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye. |
| Cohort 3 - Dose B | EXPERIMENTAL | AGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye. |
| Name | Type | Description |
|---|---|---|
| AGN-193408 SR | DRUG | An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant into the anterior chamber of the study eye. |
| Lumigan | OTHER | Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost |
| Sham Administration | OTHER | Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR. |
| Lumigan Vehicle | OTHER | Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 2. |
Inclusion Criteria: * Participant is willing to withhold his/her IOP (Intraocular Pressure) treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk. * Diagnosis of either OAG \[open-angle glaucoma\] (ie, \[POAG\], pseudoexfoliation ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 3 | PHASE4 | Travoprost Intraocular |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE4 | Test - Bimatoprost 0.01%, Reference - LUMIGAN |
| AbbVie, Inc. | ABBV | 1 | PHASE4 | Bimatoprost |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Nicotinomide |
| Alcon AG | ALC | 3 | PHASE4 | Undisclosed |