Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
100 μg KIO-301 · 1 trial · 1 indication
Change in ophthalmic and non-ophthalmic adverse events
| Arm | Type | Description |
|---|---|---|
| 50 μg KIO-301 | EXPERIMENTAL | 50 μg KIO-301 or placebo administered by IVT injection bilaterally (OU) once every 6 weeks for 3 administrations per participant. |
| 100 μg KIO-301 | EXPERIMENTAL | 100 μg KIO-301 or placebo administered by IVT injection OU once every 6 weeks for 3 administrations per participant. |
| Name | Type | Description |
|---|---|---|
| Placebo (Sterile Saline or Balanced Salt Solution) | OTHER | A control 50 μl injection of clear sterile saline or balanced salt solution (BSS) liquid. |
| 100 μg KIO-301 | DRUG | KIO-301 drug product is an ophthalmic formulation of the drug substance KIO-300-Cl in sulfobutylether-β-cyclodextrin, sucrose, phosphate buffer salts and water suitable for IVT injection. The drug substance KIO-300-Cl is a quaternary ammonium chloride salt of the active compound KIO-300. |
| 50 μg KIO-301 | DRUG | KIO-301 drug product is an ophthalmic formulation of the drug substance KIO-300-Cl in sulfobutylether-β-cyclodextrin, sucrose, phosphate buffer salts and water suitable for IVT injection. The drug substance KIO-300-Cl is a quaternary ammonium chloride salt of the active compound KIO-300. |
Inclusion Criteria: 1. Be aged 18 years or older at the time of consent. 2. Provide informed consent prior to any study procedures, as stipulated by local laws, Ethics Committee (EC) and Regulatory Authority (RA) guidelines. 3. Be willing and able to follow all study instructions, attend all study ...