Primary endpoint in phase III TRANQUILITY-2 trial in dry eye disease is achieved and plans are to submit a NDA for symptoms and three sign endpoints of dry eye disease.
Aldeyra Therapeutics, Inc. announced the achievement of the primary endpoint in the Phase III 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 greater than 10 mm Schirmer test responder proportions (p<0.0001) after a single day of dosing.
“Schirmer test is an accepted method for measuring tear production and has been used in clinical studies for over 20 years,” said Cathleen McCabe, M.D., a dry eye disease specialist for The Eye Associates in Sarasota, Florida and Chief Medical Officer at Eye Health America™. “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 greater than 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. The clinical package is expected to offer unparalleled breadth across acute trials over one to two 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.
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