Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 TRANQUILITY‑2 Trial in Dry Eye Disease
Aldeyra Therapeutics announced the achievement of the primary endpoint in the phase 3 TRANQUILITY-2 clinical trial (TRANQUILITY-2) of reproxalap, an investigational new drug candidate, for the treatment of dry eye disease. Reproxalap was statistically superior to vehicle for each of the two prespecified primary endpoints, Schirmer test (P=0.0001) and ≥10 mm Schirmer test responder proportions (P<0.0001) after a single day of dosing. The Schirmer test, a measure of ocular tear production, is the dry eye disease objective sign most commonly utilized for drug approval.
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“Schirmer test is an accepted method for measuring tear production and has been used in clinical studies for over 20 years,” Cathleen McCabe, MD, a dry eye disease specialist for The Eye Associates in Sarasota, Florida and Chief Medical Officer at Eye Health America, said in a company news release. “I am extremely encouraged about the Schirmer test results and the other clinical sign endpoint data produced by reproxalap, highlighting the broad therapeutic benefit this therapy may bring to patients suffering from dry eye disease.”
Pending discussions with the FDA, Aldeyra intends to submit an NDA with ocular dryness symptom score, ocular redness, Schirmer test, and ≥10 mm Schirmer test responder analysis, encompassing results across five adequate and well-controlled completed clinical trials.
The submission could represent the most comprehensive NDA submission in dry eye disease to date and allows for the potential of reproxalap to be the first dry eye disease drug approved with symptoms and at least two labeled objective signs, according to Aldeyra. The clinical package is expected to include data across acute trials over 1 to 2 days of dosing and chronic trials over 12 weeks of dosing, as well as a combination of challenge and field-based assessments.
A Type B Pre-NDA meeting is expected to be held with the FDA in the third quarter of 2022, followed by a potential NDA submission, pending enrollment in the ongoing 12-month safety trial, and results from a dry eye chamber crossover trial. Enrollment of the crossover dry eye disease trial is substantially complete, and results are expected in the third quarter of 2022. Pending the results, the crossover trial is intended to be submitted to the NDA as a supportive trial.
“The positive results of TRANQUILITY-2 are expected to complete the most comprehensive dry eye disease NDA submission to date,” said Todd C. Brady, MD, PhD, President and CEO of Aldeyra. “I want to express my sincere gratitude to the principal investigators and more than 1,700 patients who have participated in clinical trials of reproxalap over the past 5 years, as well as our stockholders and other stakeholders for their continued confidence in Aldeyra. For many of the more than 39 million U.S. adults who suffer from dry eye disease, we believe the need for a rapidly acting therapy with a novel mechanism of action is significant. We are confident in the potential of reproxalap to meet that need.”