Latest news with #ALDX
Business Insider
06-05-2025
- Health
- Business Insider
Aldeyra's reproxalap achieves primary endpoint in Phase 3 dry eye disease trial
Aldeyra (ALDX) announced the achievement of the primary endpoint in a Phase 3 dry eye chamber trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease. For the prespecified primary endpoint of ocular discomfort, a symptom of dry eye disease, reproxalap was statistically significantly superior to vehicle on ocular discomfort symptom score from 80 to 100 minutes after chamber entry. Aldeyra believes that the dry eye chamber trial results, which included no notable differences in baseline scores across treatment arms, potentially address the FDA feedback received in April in response to the prior NDA. The letter identified concerns with a previously completed dry eye chamber trial that may have affected the interpretation of the results. Pending a Type A meeting with the FDA, NDA resubmission is anticipated mid-2025, and the review period is expected to be six months. There were no safety signals or treatment-related discontinuations observed in either of the recently completed clinical trials, and reproxalap was observed to be well tolerated. Reproxalap has now been studied in over 2,900 patients.
Yahoo
03-04-2025
- Business
- Yahoo
Aldeyra Therapeutics Stock Craters to All-Time Low on FDA Letter
Shares of Aldeyra Therapeutics slumped nearly 75% to a record low on Thursday. The FDA told the drugmaker in a letter that its drug submitted to treat dry eye disease has not proven its effectiveness in enough trials. The company said it expects to release data from an ongoing trial in the second quarter, and resubmit the drug for approval later this of Aldeyra Therapeutics (ALDX) plummeted nearly 75% to an all-time low Thursday morning after the Food and Drug Administration (FDA) said the company's dry eye disease drug has not proven to be effective in enough studies. The developmental drug company said that it received a letter from the FDA responding to its new drug application (NDA) for reproxalap, a treatment for dry eye disease. The drug has "failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes," the FDA wrote, Aldeyra said. The agency told the firm that it needs to prove the drug's effectiveness in at least one more clinical trial. The drugmaker said it expects to announce results from an ongoing trial in the second quarter, with plans to resubmit its NDA by mid-2025 if the trial has positive results. "The review period for the potential NDA resubmission is expected to be six months," Aldeyra said. Shares of Aldeyra were down 74% in recent trading to $1.39 after earlier touching a record-low $1.18. The stock had been up nearly 30% over the past 12 months entering Thursday. Read the original article on Investopedia Sign in to access your portfolio
