Aldeyra's ADX-2191 Aces Late-Stage Study In Rare Vision Disorder

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.