Aldeyra makes third run at FDA approval for dry eye drug

US biotech Aldeyra Therapeutics (Nasdaq: ALDX) is making another attempt to gain marketing approval for its eye drop treatment reproxalap, a novel small-molecule RASP modulator, after new data from a late-stage trial showed a statistically significant benefit over placebo in reducing eye discomfort.

In a Phase III dry eye chamber study involving 116 patients, reproxalap met its primary endpoint, outperforming the control group in easing symptoms from 80 to 100 minutes after exposure to a controlled dry environment. Aldeyra said there were no major differences between the two treatment arms at the start of the trial, a factor that had previously raised concerns with US regulators.

The company said it expects to resubmit its application for reproxalap in mid-2025 and has requested a type A meeting with the US regulator to discuss the new data. In the meantime, Aldeyra has taken the unusual step of submitting the results even before the formal resubmission to the Food and Drug Administration (FDA)..