Aldeyra Therapeutics Reports the US FDA Acceptance of NDA for Priority Review of ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma
- The US FDA has accepted the NDA for Priority Review of ADX-2191 (methotrexate injection) for PVRL. The US FDA’s decision is expected on June 2023 with the planning to launch ADX-2191 in the US in H2’23
- The NDA submission was based on the combination of more than three decades of published literature on the safety & efficacy of ADX‑2191 along with the safety data from the P-III trial (GUARD). The P-III trial (GUARD) results showed no safety signals & were found to be well tolerated with no observed treatment-emergent serious AEs
- ADX-2191 is a sterile, non-compounded IVT formulation of methotrexate for specific rare retinal diseases. The therapy received ODD from the US FDA for PVR, PVRL, and retinitis pigmentosa
Ref: Aldeyra | Image: Aldeyra
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