Aldeyra plans advancement of reproxalap for dry eye
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Following preliminary discussion with the FDA, Aldeyra Therapeutics plans to continue advancing reproxalap for dry eye disease, according to a company press release.
In the discussions, the use of reactive aldehyde species (RASP) was decided to be an objective sign for the treatment of dry eye disease, the release said.
RASP, pre-cytokine pro-inflammatory mediators, present in elevated capacities in patients with dry eye disease. In a phase 2a clinical trial, the investigational RASP inhibitor reproxalap demonstrated a reduction in tear RASP levels after 28 days of treatment.
“Representing the first novel objective sign for the treatment in dry eye disease in over a decade, RASP are critical mediators of inflammation,” Aldeyra president and CEO Todd C. Brady, MD, PhD, said in the release.
When administered topically, reproxalap is thought to be more than 500-fold in excess of tear RASP levels and has demonstrated consistent significant activity in dry eye disease, allergic conjunctivitis and ocular inflammation in phase 2 and 3 trials, the release said.
Aldeyra plans to provide an update on clinical development plans and new drug application requirements for reproxalap.
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