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...
APX3330 is an investigational small molecule being developed for diabetic retinopathy, including diabetic macular edema, non-proliferative diabetic retinopathy (NPDR), and proliferative diabetic retinopathy (PDR). It is currently in Phase 2 clinical development and is not yet approved by the FDA.
APX3330 is being developed by Opus Genetics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol IRD. The company is conducting clinical trials to evaluate the safety and efficacy of APX3330 in patients with diabetic retinopathy.
APX3330 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed, and the drug is not yet approved by the FDA. It remains an investigational agent under evaluation for the treatment of diabetic retinopathy.
APX3330 has one completed Phase 2 clinical trial, identified as NCT04692688, titled 'Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy.' The trial enrolled 103 participants in the United States and included healthy volunteers.
No, APX3330 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The completed Phase 2 trial was designed to evaluate its safety and efficacy, but the drug has not yet received regulatory approval for any indication.