A sequence-randomised, double-masked, vehicle-controlled crossover clinical trial of Aldeyra’s 0.25% reproxalap ophthalmic solution have shown it was statistically superior to placebo for both primary endpoints of ocular redness in a dry eye chamber and Schirmer test after a single day of dosing.
Reproxalap is an investigational first-in-class small-molecule modulator of reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease. It has also been trialled as a topical ophthalmic solution in patients with allergic conjunctivitis*.
Although three patients discontinued treatment due to adverse events during the trial, researchers reported reproxalap was well tolerated and there were no treatment-emergent moderate or serious adverse events. Following studies in more than 1,800 patients, reproxalap’s most commonly reported adverse event is mild and transient instillation site discomfort.
Dr Todd Brady, Aldeyra president and CEO said the company intends to submit a New Drug Application for reproxalap, adding that, if approved for sale, it’s a potentially differentiated therapeutic option for the treatment of dry eye disease.
Aldeyra also announced its phase 3 Tranquility-2 trial has enrolled 361 patients randomly assigned to receive either reproxalap or placebo over two days. A company statement said the results of previous phase 2 and Tranquillity clinical trials provide Tranquility-2 with at least 90% power to detect a statistically significant difference in Schirmer test or ocular redness endpoints.
