Shares of Aldeyra Therapeutics Inc (NASDAQ:ALDX) are popping in Wednesday’s pre-market session in response to its announcement of positive results from a Phase 2b trial evaluating its drug topical ocular reproxalap in patients with dry eye disease.
Patients who received a 0.25% concentration of reproxalap showed statistically significant reductions in the Four-Symptom Ocular Dryness score (p<0.05) and the Overall Ocular Discomfort Symptom score (p<0.05). Symptom improvement measured against a placebo was observed across all measures, according to the company.
Investors welcomed the results, sending Aldeyra shares up 32% in Wednesday’s pre-market session to $13.10.
On the back of the successful Phase 2b results, Aldeyra plans to introduce a Phase 3 program for dry eye disease next year, pending discussions with US regulators.
Read: Aldeyra Therapeutics reports positive results from a phase 2a trial of its treatment for dry eye disease
“The addition of dry eye disease to our late-stage clinical portfolio, which includes Phase 3 clinical trials in allergic conjunctivitis and noninfectious anterior uveitis, highlights the potential of reproxalap as a highly differentiated and novel ophthalmic therapy,” noted Aldeyra CEO Todd Brady.
Dry eye disease is characterized by insufficient moisture and lubrication in the anterior surface of the eye, which leads to dryness and inflammation, and in severe cases, permanent vision impairment.
The three-hundred patients taking part in the Phase 2b trial received either a 0.1% or 0.25% concentration of reproxalap or a placebo for twelve weeks. Patients receiving both 0.1% and 0.25% reproxalap concentrations saw improvement in their conditions.
Topical ocular reproxalap was well tolerated and reported adverse events were generally mild.
Based in Lexington, Massachusetts, Aldeyra is also developing drugs for autoimmune disease, retinal inflammation, metabolic disease and cancer.
