Aldeyra Looking At Paths To Approval In Dry Eye After Phase III Miss

22 Dec 2021

Firm revises second Phase III trial for co-primary endpoints, possibly improving its chances of success for demonstrating efficacy on a sign of dry eye disease. Initial Phase III study missed ocular redness measure.

Blue eye detail — Aldeyra puts dry eye hopes on revised Phase III protocol

Dry eye disease is an indication that often yields surprising trial results and Aldeyra Therapeutics, Inc. is trying to encourage shareholders that it still has a viable path to approval with novel anti-inflammatory agent reproxalap after a Phase III miss on a sign of the disease. In top-line data reported on 20 December, Aldeyra said reproxalap failed to meet statistical significance for ocular redness, despite hitting that same endpoint in a smaller Phase II trial.

The company explained after the stock market closed on 20 December that it still may be able to obtain approval...