Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APX3330 · 1 trial · 4 indications
Percent of subjects with a ≥ 2-step improvement in DRSS in the study eye
| Arm | Type | Description |
|---|---|---|
| APX3330 | EXPERIMENTAL | Five 120 mg tablets will be taken by mouth as follows: 3 tablets every morning and 2 tablets every evening. |
| Placebo | PLACEBO_COMPARATOR | Five 120 mg tablets will be taken by mouth as follows: 3 tablets every morning and 2 tablets every evening. |
| Name | Type | Description |
|---|---|---|
| APX3330 | DRUG | APX3330, a small-molecule oral tablet, is a Ref-1 inhibitor that can potentially reduce proinflammatory and hypoxic signaling that contributes to several eye diseases. |
| Placebo | DRUG | Placebo tablets are identical to APX3330 tablets except for the absence of the active pharmaceutical ingredient. |
Inclusion Criteria: 1. Males or non-pregnant females ≥ 18 years of age 2. At least one eye with DR graded at least moderately severe to severe NPDR or mild PDR (corresponding to DRSS 47, 53, or 61) 3. BCVA assessed by ETDRS protocol letters score of ≥ 60 letters (Snellen equivalent ≥ 20/63) 4. Body...