Aldeyra Therapeutics has enrolled the first patient in a Phase III INVIGORATE clinical trial being conducted to assess reproxalap for the treatment of allergic conjunctivitis.
Reproxalap is a small molecule covalent inhibitor of reactive aldehyde species (RASP), which are known to be higher in ocular and systemic inflammatory diseases. RASP cause the activation of intracellular inflammatory factors, including NF-kB, inflammasomes and Scavenger Receptor A.
Reproxalap demonstrated statistically significant and clinically relevant activity in late-phase clinical conditions, according to the company.
A 0.25% dose of the immune-modulating drug led to a statistically significant decrease in ocular itching and redness in a Phase II allergen chamber clinical methods study, compared to the vehicle.
The randomised, double-masked, crossover vehicle-controlled INVIGORATE trial is designed to compare the safety and efficacy of the 0.25% reproxalap ophthalmic solution to a vehicle using an allergen chamber.
The study, which is set to enrol a total of 120 participants, will track subject-reported ocular itching score as the primary endpoint. Secondary outcomes include conjunctival redness assessed by the subject.
It is expected to be completed in September.
Aldeyra Therapeutics president and CEO Todd Brady said: “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.”
Last month, Aldeyra commenced enrolment in the Phase III GUARD clinical trial of ADX-2191 being developed to prevent a rare retinal disease called proliferative vitreoretinopathy.