Aldeyra Therapeutics (NASDAQ:ALDX) announced on Thursday that its investigational new drug reproxalap ophthalmic solution for patients with allergic conjunctivitis has achieved statistical significance for the primary endpoint of ocular itching and all secondary endpoints in a Phase 3 clinical trial, sending the company’s stock soaring.
“Consistent with the results of the Phase 3 INVIGORATE Trial and in conjunction with a number of successful Phase 2 and Phase 3 clinical trials in dry eye disease, achievement of the primary endpoint and all secondary endpoints in INVIGORATE-2 supports the potential of reproxalap as a treatment for inflammatory diseases of the ocular surface,” said Aldeyra CEO Dr. Todd Brady.
“We believe that the rapid-onset activity of reproxalap evidenced in the INVIGORATE clinical trials may offer hope to allergic conjunctivitis patients who are today not adequately treated, and also to dry eye disease patients, up to 50% of whom suffer from ocular allergy.”
A New Drug Application of reproxalap for the treatment of dry eye disease is under review at the US Food and Drug Administration, Aldeyra noted.
The NDA Prescription Drug User Fee Act date for reproxalap for the treatment of dry eye disease is November 23, 2023.
Aldeyra stock was up 12.3% at US$11.74 on Thursday morning.
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