Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ADX-2191 · 2 trials · 2 indications
Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates
The proportion of subjects that experience at least one serious adverse event
| Arm | Type | Description |
|---|---|---|
| ADX-2191 (intravitreal methotrexate 0.8%) | EXPERIMENTAL | ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks. |
| Standard surgical care procedure | ACTIVE_COMPARATOR | Standard procedure performed. |
| ADX-2191 Three Injections | EXPERIMENTAL | - |
| ADX-2191 Six Injections | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ADX-2191 (intravitreal methotrexate 0.8%) | DRUG | ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy |
| Standard surgical care procedure | OTHER | Standard surgical care performed upon completion of pars plana vitrectomy |
| ADX-2191 | DRUG | Monthly intravitreal injections of ADX-2191 (400 µg in 0.05 mL) for a total of three injections. Evaluation through week 16. |
Inclusion Criteria: 1. Subject is 18 years or older of any gender or race 2. Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretinopathy or open globe injury 3. Subject is willing and able to provide written informed consent, comply with cl...
ADX-2191 is an investigational small molecule being developed for proliferative vitreoretinopathy and retinitis pigmentosa, both ophthalmology conditions. It is not approved and remains in clinical development.
ADX-2191 is being developed by Aldeyra Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker ALDX.
ADX-2191 is in Phase 3 clinical development for proliferative vitreoretinopathy. It has received FDA priority review and orphan drug designations, but it is not yet approved.
ADX-2191 has been studied in two completed trials. NCT04136366 was a Phase 3 trial for proliferative vitreoretinopathy with 106 participants, and NCT05392179 was a Phase 2 trial for retinitis pigmentosa with 8 participants.
ADX-2191 is not FDA approved. It is an investigational drug that has completed clinical trials, including a Phase 3 study, and has received priority review and orphan drug designations from the FDA.