Aldeyra planning Phase III trial of ADX-102 despite Phase IIb miss in allergic conjunctivitis

Aldeyra Therapeutics Inc. (NASDAQ:ALDX) reported data from a Phase IIb trial in 154 patients with acute allergic conjunctivitis, including seasonal and perennial allergies, showing that 0.1% and 0.5% doses of ADX-102 ophthalmic drops both missed the primary endpoint of a ≥1-point improvement patient-reported ocular itching as measured by the Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale vs. vehicle-treated controls. At 1 hour post-challenge, 0.5% ADX-102 did significantly reduce ocular itching vs. vehicle (p<0.03). High-dose ADX-102 also significantly reduced ocular itching at 10, 20 and 30 minutes post-challenge vs. vehicle (p=0.02, p=0.04 and p=0.03, respectively).

In patients with seasonal allergies, ADX-102 led to significant reductions of up to 0.8 points in patient-reported ocular itching vs. vehicle (p=0.002). Additionally, 0.5% ADX-102 improved itch score post-challenge by 23% at 10 minutes, 37% at 20 minutes, 55% at 30 minutes and 65% at 60 minutes vs. vehicle. ADX-102 was generally well tolerated...