Aldeyra Therapeutics has concluded the subject enrolment in the Phase III TRANQUILITY clinical trial of its experimental therapy, a 0.25% reproxalap ophthalmic solution (reproxalap), to treat people with dry eye disease.
Reproxalap is a new small-molecule immune-modulating covalent inhibitor of reactive aldehyde species.
The double-masked, multicentre parallel-group Phase III trial enrolled 300 subjects, who were categorised to give either reproxalap or a vehicle.
Subjects were given four doses one day before and two doses on the day of their exposure to a 90-minute dry eye chamber with low humidity, increased airflow, and compelled visual tasking.
Ocular redness is the primary goal of the trial with top-line data anticipated in this quarter of the year.
A Phase II trial with 158 subjects achieved statistical significance in the primary goal of ocular redness.
Aldeyra is also carrying out another identical Phase III trial, TRANQUILITY-2, in dry eye disease patients. Enrolment is underway for this trial.
Aldeyra president and CEO Todd Brady said: “Following the recent announcement of top-line results from our Phase II clinical trial, which achieved the primary endpoint of ocular redness, and which we intend to submit as a pivotal trial, completion of enrolment in TRANQUILITY is a significant milestone as we advance reproxalap toward an anticipated NDA submission early next year for the treatment of dry eye disease.
“If the primary endpoint of ocular redness in TRANQUILITY is achieved, and in conjunction with two previously announced clinical trials demonstrating improvement in ocular dryness symptoms, we believe that the efficacy requirements for NDA submission will have been met.”
The company intends to submit the Phase II data, as well as positive Ocular Redness results from the TRANQUILITY trial, to seek New Drug Application (NDA) from the US Food and Drug Administration (FDA) early next year.