A phase 3 trial of Aldeyra Therapeutics’ dry eye disease prospect has hit its primary endpoint, preparing the biotech to seek approval for a candidate the FDA has rejected twice in recent years. Another phase 3 trial missed its primary endpoint, but Aldeyra said the data can still support its latest resubmission.

The FDA has set back Aldeyra Therapeutics’ ambitions to win approval for its dry eye disease, rejecting its second application for approval and calling for data from at least one more study. But with a trial set to read out this quarter, the biotech is aiming to bounce back and resubmit its application in mid-2025.

After an FDA rejection last year, Aldeyra Therapeutics has scored a clinical win for dry eye drug reproxalap, which significantly reduced ocular discomfort in a new phase 3 study.

Palatin Technologies has some changes to make for the upcoming trials of the dry eye disease drug PL9643 after the phase 3 MELODY-1 study failed on the main goal of improving a clinical sign of the disorder.

Alcon plans to file for regulatory approval for its dry eye drug with the FDA in mid-2024 after pivotal efficacy and safety studies met the primary endpoints.

The FDA on Monday rejected Aldeyra Therapeutics’ investigational reactive aldehyde species modulator reproxalap, which the company is proposing as a treatment for dry eye disease.

Aldeyra Therapeutics on Monday announced in an SEC filing that the FDA is likely to reject its New Drug Application for reproxalap for the treatment of dry eye disease.

This follows a late-cycle review meeting in which the regulator flagged “substantive review issues” with the New Drug Application (NDA).

To boost its over-the-counter eye care efforts, Bausch + Lomb has acquired eye and contact lens drops under Johnson & Johnson Vision’s Blink product line, the Canadian company announced Thursday.