Aldeyra plans new drug application resubmission for reproxalap
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Key takeaways:
- A dry eye chamber trial will begin in the first half of 2024.
- Aldeyra plans to resubmit the new drug application later this year, pending positive results.
Nearly 5 months after the FDA did not approve reproxalap for dry eye, Aldeyra Therapeutics has announced a plan to resubmit a new drug application for the reactive aldehyde species modulator, according to a press release.
The company plans to initiate a dry eye chamber clinical trial in the first half of 2024 and expects to resubmit the NDA in the second half of the year, contingent on positive results from the trial, according to the release.
“The planned dry eye chamber clinical trial, if successful, could represent the first pivotal demonstration of rapid improvement in the symptoms of dry eye disease, a potentially debilitating and increasingly pervasive condition that affects millions of patients worldwide,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, said in the release.
In the study, researchers plan to administer vehicle to patients before and during exposure to a dry eye chamber. Qualifying patients will later be assigned to receive either reproxalap or vehicle before and during exposure to an additional dry eye chamber. The primary endpoint of the study is ocular discomfort, according to the release.
The NDA rejection of the therapy by the FDA in November 2023 was due to a lack of demonstrated efficacy for treating ocular symptoms of dry eye disease, and the agency suggested that at least one more study was needed to demonstrate a positive effect on symptoms, according to a previous press release.
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