Aldeyra enrolls first patient in phase 3 trial of reproxalap for dry eye disease
Click Here to Manage Email Alerts
Aldeyra Therapeutics has enrolled the first patient in a phase 3 clinical trial designed to allow possible resubmission of the new drug application of topical 0.25% reproxalap for dry eye disease, according to a company press release.
The company plans to resubmit the NDA of reproxalap, an investigational RASP modulator, to the FDA in the second half of 2024 and aims to include a draft label describing chronic and acute improvement in symptoms and ocular redness, contingent on positive results from this dry eye chamber clinical trial.
“The future of dry eye disease therapeutics is rapid onset of activity, which remains the most significant unmet medical need,” Todd Brady, MD, PhD, Aldeyra’s CEO, president and director, told Healio. “In contrast to traditional environmental exposure trials, dry eye chamber trials allow for acute assessment of activity in minutes. With reproxalap, reduction of ocular redness — the dry eye disease sign that matters most to patients — has been demonstrated in the chamber, and the recently initiated trial will assess symptoms in the chamber.”
According to the release, participants in the trial will receive vehicle before and during exposure to a dry eye chamber, with qualifying patients then randomly assigned to reproxalap or vehicle before and during exposure to an additional dry eye chamber. The company expects to enroll about 110 individuals.
In four completed dry eye chamber trials, ocular discomfort in the chamber after treatment with reproxalap was statistically lower than that of vehicle, the release stated.
Read more about
Click Here to Manage Email Alerts