Aldeyra initiates phase 3 reproxalap trial

The first patient has been enrolled in a phase 3 trial of Aldeyra Therapeutics’ allergic conjunctivitis treatment candidate reproxalap, according to a press release.

The randomized, double-masked, crossover vehicle-controlled phase 3 INVIGORATE trial will enroll approximately 120 patients and assess the efficacy and safety of reproxalap ophthalmic solution 0.25% compared with vehicle.

“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 the 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.”

A phase 2 trial found statistically significant reductions in ocular itching and redness in patients treated with reproxalap compared with those treated with vehicle.

The first patient has been enrolled in a phase 3 trial of Aldeyra Therapeutics’ allergic conjunctivitis treatment candidate reproxalap, according to a press release.

The randomized, double-masked, crossover vehicle-controlled phase 3 INVIGORATE trial will enroll approximately 120 patients and assess the efficacy and safety of reproxalap ophthalmic solution 0.25% compared with vehicle.

“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 the 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.”

A phase 2 trial found statistically significant reductions in ocular itching and redness in patients treated with reproxalap compared with those treated with vehicle.