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Also known as ADX-2191 (intravitreal methotrexate 0.8%), ICM ADX-2191 injection, ICM ADX-2191, Monthly ADX-2191 injection, Monthly ADX-2191
ADX-2191 · 3 trials · 3 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 |
|---|---|---|
| Induction/Consolidation/Maintenance (ICM) ADX-2191 injection | EXPERIMENTAL | - |
| Monthly ADX-2191 injection | ACTIVE_COMPARATOR | - |
| 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 |
|---|---|---|
| ICM ADX-2191 injection | DRUG | Following the development of lymphomatous vitreous cells in at least one eye, subjects will follow ICM dosing with ADX-2191 intravitreal injections twice weekly for four weeks, followed by weekly for eight weeks, for a total of sixteen injections. |
| Monthly ADX-2191 injection | DRUG | Following the development of lymphomatous vitreous cells in at least one eye, subjects will dose monthly with ADX-2191 intravitreal injections for a total of three injections. Sham injections will be performed for those visits during which ADX-2191 is not injected, for a total of thirteen sham injections. |
| 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. 21 years old or older; of any gender 2. Biopsy proven primary vitreoretinal lymphoma 3. Presence of lymphomatous vitreous cells at the Screening Visit and/or any eye that has been vitrectomized to confirm the diagnosis of primary vitreoretinal lymphoma 4. Willingness to parti...
ADX-2191 is an investigational small molecule drug developed by Aldeyra Therapeutics for retinal diseases. It is being studied in primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and retinitis pigmentosa. It is a proprietary formulation of intravitreal methotrexate 0.8% designed for intravitreal injection. It has received FDA priority review and orphan drug designations.
ADX-2191 is being developed for three retinal conditions: primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and retinitis pigmentosa. The most advanced program is in proliferative vitreoretinopathy, where the Phase 3 GUARD Trial has been completed. A Phase 3 trial in primary vitreoretinal lymphoma is currently recruiting, and a Phase 2 study in retinitis pigmentosa has been completed.
ADX-2191 is developed by Aldeyra Therapeutics, Inc., a biotechnology company traded on the Nasdaq under the ticker ALDX. Aldeyra is advancing the drug across retinal indications including primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and retinitis pigmentosa.
ADX-2191 is in Phase 3 clinical development. The Phase 3 GUARD Trial in proliferative vitreoretinopathy has been completed, and a Phase 3 trial in primary vitreoretinal lymphoma is currently recruiting. A Phase 2 trial in retinitis pigmentosa has also been completed. The drug is investigational and has not been approved by the FDA.
ADX-2191 has been studied in three registered trials. NCT04136366, the Phase 3 GUARD Trial, evaluated prevention of proliferative vitreoretinopathy and completed with 106 patients. NCT07402876 is a recruiting Phase 3 trial in primary vitreoretinal lymphoma. NCT05392179 was a completed Phase 2 study in retinitis pigmentosa.
ADX-2191 is also known as intravitreal methotrexate 0.8%, ICM ADX-2191 injection, ICM ADX-2191, monthly ADX-2191 injection, and monthly ADX-2191. These names refer to the same Aldeyra Therapeutics product, a proprietary small molecule formulation of methotrexate administered by intravitreal injection for retinal diseases.