Aldeyra Therapeutics Phase 3 SOLACE Trial Fails to Meet Primary Endpoint in Noninfectious Anterior Uveitis

Aldeyra Therapeutics announced results from the noninfectious anterior uveitis SOLACE trial. Statistical significance was not achieved for the primary or secondary endpoints, due to high rates of disease resolution in vehicle-treated patients, but activity of reproxalap was consistently greater than that of vehicle.

“The results of the SOLACE Trial confirm the potential of reproxalap to treat ocular inflammation, and further validate the novel mechanism of action of reproxalap, which demonstrated highly statistically significant immune-modulating activity in the Phase 3 ALLEVIATE Trial and Phase 2b Dry Eye Disease trial,” Todd C. Brady, MD, PhD, President and Chief Executive Officer of Aldeyra, said in a company news release. “We look forward to aggressively prioritizing advancement of high-value ocular programs in dry eye disease, allergic conjunctivitis, and proliferative vitreoretinopathy.”

Topical ocular reproxalap was observed to be safe and well-tolerated. Reproxalap ophthalmic solution, in various concentrations, has now been administered to over 800 patients in nine clinical trials for ocular inflammation.