Aldeyra Therapeutics Announces First Patient Enrolled in the Phase 3 INVIGORATE Trial in Allergic Conjunctivitis

Aldeyra Therapeutics announced enrollment of the first patient into the phase 3 INVIGORATE trial of topical ocular reproxalap in patients with allergic conjunctivitis.

“Initiating enrollment in the INVIGORATE trial moves us closer to our goal of providing allergic conjunctivitis patients with a new treatment option for one of the world’s most common ocular conditions,” Todd C. Brady, MD, PhD, President and CEO of Aldeyra, said in a company news release. “Standard of care antihistamines are ineffective in nearly a quarter of all allergic conjunctivitis patients, many of whom require adjunct therapy, including corticosteroids, which cannot be used chronically due to toxicity. We believe that reproxalap may offer a durable and highly differentiated approach for the treatment of ocular allergy, a condition that is increasing in prevalence but has not benefited from the introduction of a novel therapeutic approach in decades.”

The INVIGORATE trial, which will enroll approximately 120 patients, is a randomized, double-masked, crossover vehicle-controlled phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared with vehicle using an allergen chamber. Consistent with prior allergic conjunctivitis trials, the primary endpoint will be subject-reported ocular itching score.

In Aldeyra’s phase 2 allergen chamber clinical methods trial, completed in March 2019, 0.25% reproxalap demonstrated highly statistically significant reductions from vehicle in ocular itching and redness.

More information about the INVIGORATE Trial is available on www.clinicaltrials.gov (NCT04207736).