Mixed Early Phase III Results With Aldeyra’s First-In-Class Dry Eye Candidate

Aldeyra To Initiate Part 2 Of The Adaptive Phase III Study In 2020

The first part of Aldeyra’s Phase III RENEW study of the aldehyde trap candidate, reproxalap, shows positive effects on one of two co-primary endpoints and indicates an induction-maintenance dosing regimen should be used in part 2 of the study, expected to start in the first half of next year.

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Aldeyra Therapeutics Inc. has presented mixed top-line results from part 1 of its adaptive Phase III RENEW study of the potential first-in-class dry eye disease therapy, reproxalap, and investors have reacted cautiously to the data.

The Lexington, MA-based biotech’s share price on NASDAQ declined by 32% on 3 December to $5.06, the day the data...

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Aldeyra Readies Reproxalap For Dry Eye Refiling After Chamber Study Success

 
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The company said earlier this year that it would resubmit reproxalap for US FDA approval before the end of 2024 once it completed another Phase III trial and is eyeing both acute and chronic use.

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