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Aldeyra Claims Success In Final Phase III For First-In-Class Dry Eye Drug

Both Co-Primary Endpoints Hit In TRANQUILITY-2

 
• By Jessica Merrill

The company plans to submit an NDA for reproxalap for dry eye disease based on the results and hailed the crossover trial design as unique in the therapeutic area.

eye dropper
Aldeyra is developing a new eye drug • Source: Shutterstock

Aldeyra Therapeutics, Inc. believes it has the data it needs to file for US Food and Drug Administration approval of reproxalap for dry eye disease following successful completion of a Phase III study that met co-primary endpoints for ocular redness and tear production, and that the data position reproxalap well to compete in the dry eye market.

The company announced the clinical trial results on 12 July, about six months after its initial Phase III trial, TRANQUILITY, failed to meet the primary endpoint of ocular redness. Aldeyra pivoted at the time and revised the primary endpoint of the ongoing second Phase III study, TRANQUILITY-2, to make Schirmer test (a measure of tear production) a co-primary endpoint along with ocular redness

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