Aldeyra Therapeutics Inc. (NASDAQ:ALDX) has announced that it has reached an agreement with the FDA regarding the uses of reactive aldehyde species (RASP) as the objective sign in dry eye disease treatment.
Reproxalap demonstrated significant RASP tear level reduction
The agreement comes following an initial meeting discussion and written comments over the same. RASP refers to the pre-cytokine inflammatory mediators which are usually elevated in tears of dry eye disease patients. It correlates with signs and symptoms of dry eye disease. In the phase 2a clinical study for dry eye disease, the company’s investigation RASP inhibitor reproxalap showed a significant reduction in RASP tear levels after 28 days of treatment.
On the other hand, in vitro trials, exposure to reproxalap for patients at equimor levels resulted in the elimination of RASP after 60 minutes to 90 minutes. The topical administering of reproxaalap to the eye is more than 500 times in excess of RASP tear levels and has shown statistically significant as well as relevant clinical activity. This was consistent in allergic conjunctivitis, dry eye disease, and other ocular inflammation types in various second and third phase trials.
Aldeyra gearing for NDA submission for reproxalap
Aldeyra CEO and President Todd Brady indicated that RASP are important inflammation mediators, and they represent the first proprietary objective sign for treating dry eye disease in almost a decade. Brady stated that the company was looking forward to continuing to advance reproxalap as a proprietary RASP inhibitor in the third phase clinical trials for allergic conjunctivitis and dry eye disease in the path toward NDA submission.
The company is expected to release an update regarding its clinical development program as well as the remaining requirements for NDA filing for reporxalap in the treatment of dry eye diseases. This is after the FDA meeting minutes that are expected in July 2020. Besides reproxalap, the company’s other lead compound ADX-629, is also a reactive aldehyde species targeting systemic and ocular inflammatory disease resulting in elevated cytokine release levels through activation of inflammatory factors like inflammasomes, Scavenger Receptor, and NF-kB.