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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04188015 | Study of ANX007 in Participants With Primary Open-angle Glaucoma | PHASE1 | COMPLETED | 17 | — | — | Jul 25, 2018 | Jun 3, 2019 | Aug 20, 2020 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| 2.5mg ANX007 | EXPERIMENTAL | 1 in every 3 subjects will be randomized to 2.5mg dose of ANX007. |
| 5.0mg ANX007 | EXPERIMENTAL | 1 in every 3 subjects will be randomized to 5.0mg dose of ANX007. |
| Sham Procedure | SHAM_COMPARATOR | 1 in every 3 subjects will have a sham procedure performed instead of receiving ANX007. |
| Name | Type | Description |
|---|---|---|
| 2.5mg ANX007 | BIOLOGICAL | A single dose of 2.5mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29. |
| 5.0mg ANX007 | BIOLOGICAL | A single dose of 5.0mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29. |
| Sham Procedure | OTHER | The sham injection is preformed by applying pressure to the eye at the location of a typical IVT injection using the blunt end of a syringe without a needle. |
Inclusion Criteria: 1. Male or female age 18 years, and above. 2. Diagnosis of primary open-angle glaucoma. 3. Ability to perform a reliable visual field test in the study eye with a cutoff of 33% for fixation losses and 33% for false-positive response rates. 4. Intraocular pressure (IOP) \<21 mm H...
| 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 |