Reproxalap does not meet ocular redness primary endpoint in phase 3 dry eye trial
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Reproxalap did not meet the primary endpoint of ocular redness but achieved statistical significance in the secondary endpoint of Schirmer test in a phase 3 clinical trial, according to a press release from Aldeyra Therapeutics.
The TRANQUILITY trial, which evaluated reproxalap in patients with dry eye disease, failed to meet the primary endpoint of ocular redness. However, the trial did achieve statistical significance in the dry eye disease sign of Schirmer test (P = .0001), a secondary endpoint, as well as for post hoc assessment of Schirmer test responders of 10 mm or greater (P < .0001). There were no reported safety signals in the trial.
Because Schirmer test has been accepted by the FDA as part of the approval for other dry eye disease products, Aldeyra is altering the primary endpoint of the upcoming phase 3 TRANQUILITY-2 trial to be satisfied if either Schirmer score or ocular redness reaches statistical significance, according to the release.
“Following the achievement of statistical significance in ocular redness in our recent phase 2 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,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra, said in the release.
Topline results of TRANQUILITY-2 and a new drug application submission for reproxalap are anticipated in mid-2022.
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