First patient enrolled in Phase 3 trial of reproxalap for dry eye disease
The first patient has been enrolled in the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution (Aldeyra Therapeutics, Inc) for the treatment of dry eye disease, according to a company press release.
The trial will evaluate the safety and efficacy of reproxalap compared to vehicle in objective sign endpoints of dry eye disease, including tear RASP (reactive aldehyde species) levels after single and multiple doses, and after exposure to a dry eye chamber; Schirmer test (tear volume) following a single dose; and conjunctival redness in the dry eye chamber over 90 minutes.
“Initiation of the Phase 3 TRANQUILITY Trial, the first trial designed to characterize the acute effects of reproxalap on RASP and other objective signs of dry eye disease, marks another important step toward a planned NDA submission in dry eye disease by the end of 2021,” said Todd C. Brady, MD, PhD, in the press release. “For the more than 30 million U.S. patients with dry eye disease, we believe that reproxalap has the potential to fulfill significant unmet need as a treatment with rapid onset of action and durable symptom control.”
Read the full press release here.