Aldeyra Therapeutics Reaches Agreement with the US Food and Drug Administration for the Use of RASP as an Objective Sign for the Treatment of Dry Eye Disease

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced that, based on preliminary written comments and meeting discussion, agreement has been reached with the US Food and Drug Administration (FDA) for the use of RASP (reactive aldehyde species) as an objective sign for the treatment of dry eye disease.

RASP are pre-cytokine pro-inflammatory mediators that are elevated in the tears of patients with dry eye disease,¹ and correlate with dry eye disease symptoms and signs.² In a Phase 2a dry eye disease clinical trial, Aldeyra’s investigational first-in-class RASP inhibitor reproxalap demonstrated reduction in tear RASP levels following 28 days of treatment. In in vitro studies, RASP were eliminated within 60 to 90 minutes when exposed to reproxalap at equimolar concentrations. Reproxalap, when administered topically to the eye, is thought to be more than 500-fold in excess of tear RASP levels, and has demonstrated consistent statistically significant and clinically relevant activity in dry eye disease, allergic conjunctivitis, and other forms of ocular inflammation across numerous Phase 2 and Phase 3 clinical trials.

“Representing the first novel objective sign for the treatment in dry eye disease in over a decade, RASP are critical mediators of inflammation,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “We look forward to continuing to advance reproxalap, our novel RASP inhibitor in Phase 3 clinical trials for dry eye disease and allergic conjunctivitis, toward NDA filing.”

Aldeyra expects to provide an update on clinical development plans and remaining NDA requirements for reproxalap in dry eye disease following receipt of FDA meeting minutes, which are anticipated in July 2020.

About Aldeyra Therapeutics

Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company’s lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease, leading to elevated levels of cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company’s clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in Phase 2 testing for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.