Aldeyra Therapeutics has reported that its new experimental drug, 0.25% reproxalap ophthalmic solution (reproxalap) failed to meet the primary goal in Phase III TRANQUILITY clinical trial to treat dry eye disease.
However, for secondary endpoint of the Schirmer test, the trial attained statistical significance.
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The Schirmer test is recognised by the US Food and Drug Administration (FDA) as one of the criteria for approving various dry eye disease therapies.
Reproxalap is a small-molecule immune-modulating covalent inhibitor of reactive aldehyde species (RASP), which are raised in ocular as well as systemic inflammatory disease.
Last month, the company concluded the participant enrolment in the Phase III TRANQUILITY trial of reproxalap for dry eye disease treatment.
Findings also showed that the drug attained statistical significance for the post-hoc analysis of Schirmer test responders of ≥10mm.
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By GlobalDataIn the trial, no safety signals were detected and reproxalap demonstrated to be well-tolerated.
In addition, no drug-associated adverse events or discontinuations were reported in the trial with mild and transient instillation site discomfort found to be the most common side effect.
With the latest development, the primary goal of the impending Phase III TRANQUILITY-2 trial was altered to achieve statistical significance on the Schirmer test or ocular redness.
Furthermore, the target subject enrolment in this trial was raised to up to 400 from 300.
Top-line data from the TRANQUILITY-2 trial is anticipated in the middle of next year.
The company plans to file New Drug Application for reproxalap to treat dry eye disease during the same time, with the conclusion of subject enrolment in the 12-month safety trial underway and obtaining TRANQUILITY-2 trial data.
Aldeyra Therapeutics president and CEO Todd Brady said: “Following the achievement of statistical significance in ocular redness in our recent Phase II clinical trial, the achievement of statistical significance of Schirmer test in TRANQUILITY may provide an additional option to satisfy the remaining objective sign requirement for dry eye disease NDA submission.
“Subject to agreement with the FDA, we believe that the TRANQUILITY results allow for the possibility that, pending the outcome of TRANQUILITY-2, the NDA submission for reproxalap could represent the first time a dry eye disease drug will have qualified for the demonstration of activity for two objective signs.”
Characterised by insufficient moisture and lubrication in the anterior eye surface, dry eye disease is an inflammatory ailment.
