Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AKB-9778 4% · 1 trial · 2 indications
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 |
|---|---|---|---|---|
| SpyGlass Pharma, Inc. | SGP | 5 | PHASE3 | Bimatoprost System, BIM-DRS |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE3 | Bimatoprost ophthalmic solution |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | AGN-193408 |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE1 | REGN22530 |
| Glaukos Corp | GKOS | 2 | - | Travoprost |
AKB-9778 4% is an investigational small molecule ophthalmic solution developed by EyePoint, Inc. for ocular hypertension. It is a topical eye drop formulation being studied as an adjunct to latanoprost, a commonly used prostaglandin analog for lowering intraocular pressure. It is not approved and remains in clinical development.
AKB-9778 4% is being studied for ocular hypertension, where intraocular pressure is elevated, and for primary open angle glaucoma. In the Phase 2 trial, it was evaluated as an adjunct to latanoprost in patients with these conditions. It is investigational and has not been approved for any use.
AKB-9778 4% is developed by EyePoint, Inc., which trades on the Nasdaq under the ticker EYPT. EyePoint is an ophthalmology-focused biopharmaceutical company. The company sponsored the Phase 2 study of the ophthalmic solution as an adjunct to latanoprost in patients with ocular hypertension or open angle glaucoma.
AKB-9778 4% is in Phase 2 development. The single completed trial, NCT04405245, was a Phase 2 study that enrolled 194 patients with ocular hypertension or primary open angle glaucoma. The drug is investigational and has not been approved by the FDA for any indication.
AKB-9778 4% has been studied in one Phase 2 trial, NCT04405245, titled a study to assess the efficacy, safety and tolerability of AKB-9778 ophthalmic solution as an adjunct to latanoprost in patients with ocular hypertension or open angle glaucoma. The trial was completed, enrolled 194 patients in the United States, and was randomized, double-blind, and placebo-controlled.