- Aldeyra Therapeutics Inc ALDX achieved the primary endpoint in Part 1 of the Phase 3 GUARD Trial of ADX-2191 (methotrexate injection, USP) for intravitreal administration to prevent proliferative vitreoretinopathy (PVR).
- ADX-2191 was statistically superior to historical control for preventing retinal detachment due to PVR over six months.
- The results of the GUARD trial also demonstrated the numerical superiority of ADX-2191 over routine surgical care in reducing the dichotomous endpoints of low intraocular pressure, complete retinal attachment by six months, macular attachment by six months, and epiretinal membrane formation.
- Also see: Aldeyra's Reproxalap Hits Primary Goals In Dry Eye Disease Chamber Crossover Trial.
- Visual acuity was similar between ADX-2191 treatment and routine surgical care groups. Central macular thickness was numerically lower in ADX-2191-treated patients.
- No safety signals were observed in the trial, and ADX-2191 was well tolerated; there were no treatment-emergent serious adverse events.
- Aldeyra will discuss the ADX-2191 data with the FDA in 1H of 2023.
- Price Action: ALDX shares are down 4.30% at $5.34 on the last check Thursday.
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