Aldeyra Therapeutics announced an agreement with the FDA for the use of RASP (reactive aldehyde species) as an objective sign for the treatment of dry eye disease.
RASP is a pre-cytokine pro-inflammatory mediator that is elevated in the tears of patients with dry eye disease, and correlates with dry eye disease symptoms and signs. In a phase 2A dry eye disease clinical trial, Aldeyra’s investigational RASP inhibitor reproxalap demonstrated reduction in tear RASP levels following 28 days of treatment. In in vitro studies, RASP was 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.
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.