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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04405245 | Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma | PHASE2 | COMPLETED | 194 | — | — | Jun 6, 2020 | Nov 5, 2020 | May 25, 2023 | 21 | United States |
Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population
| Arm | Type | Description |
|---|---|---|
| AKB-9778 4% QD + Latanoprost | EXPERIMENTAL | • AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days |
| AKB-9778 4% BID + Latanoprost | EXPERIMENTAL | • AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days |
| Placebo Twice Daily + Latanoprost | PLACEBO_COMPARATOR | • Placebo for AKB-9778 4% ophthalmic solution twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days |
| Name | Type | Description |
|---|---|---|
| Latanoprost ophthalmic solution | DRUG | Latanoprost opthalmic solution to be dosed once daily |
| AKB-9778 4% | DRUG | Razuprotafib opthalmic solution |
| Placebo | DRUG | placebo for razuprotafib opthalmic solution |
Key Inclusion Criteria: * Diagnosis of OAG or OHT in each eye (OAG in one eye and OHT in the fellow eye is acceptable) * Must be receiving treatment with a stable regimen of topical prostaglandin eyedrop for a minimum of 2 weeks prior to the Screening Visit; may be taking one additional IOP lowerin...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Bimatoprost, AGN-193408 |
| SpyGlass Pharma, Inc. | SGP | 4 | PHASE3 | Bimatoprost System, Timolol , 0.5% |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 2 | PHASE3 | Test - Bimatoprost 0.01%, Reference - LUMIGAN, Bimatoprost , 0.01%, LUMIGAN 0.01% |
| Glaukos Corp | GKOS | 1 | — | Travoprost |