Treatment with reproxalap 0.25% ophthalmic solution led to statistically significant improvements in patients with allergic conjunctivitis, according to topline data from the phase 3 INVIGORATE-2 trial.
Reproxalap is an investigational, first-in-class small molecule modulator of RASP (reactive aldehyde species). The phase 3 INVIGORATE‑2 trial (ClinicalTrials.gov Identifier: NCT05234554) included 131 adult patients who at least a 2-year history of moderate to severe ragweed-induced allergic conjunctivitis.
Study participants were randomly assigned to receive reproxalap 0.25% ophthalmic solution or vehicle. The primary endpoint was the change from baseline in patient-reported ocular itching score over a majority of 11 timepoints from 110 to 210 minutes after allergen chamber entry.
Findings showed that reproxalap significantly reduced ocular itching at all prespecified timepoints compared with vehicle (P <.0001 for each comparison). Reproxalap was also associated with a statistically significant reduction in ocular redness vs vehicle (key secondary endpoint; P =.004). Statistically significant improvements in patient-reported ocular tearing score (P <.0001) and total ocular severity score (P <.0001) were also reported.
“We believe that the rapid-onset activity of reproxalap evidenced in the INVIGORATE clinical trials may offer hope to allergic conjunctivitis patients who are today not adequately treated, and also to dry eye disease patients, up to 50% of whom suffer from ocular allergy,” said Todd C. Brady, MD, PhD, President and CEO of Aldeyra.
In February 2023, the Food and Drug Administration (FDA) accepted for review the New Drug Application for reproxalap for the treatment of the signs and symptoms of dry eye disease.
References:
Aldeyra Therapeutics announces achievement of statistical significance for primary endpoint and all secondary endpoints in phase 3 INVIGORATE 2 trial of reproxalap in allergic conjunctivitis. News release. Aldeyra Therapeutics. Accessed June 15, 2023. https://www.businesswire.com/news/home/20230615100812/en/Aldeyra-Therapeutics-Announces-Achievement-of-Statistical-Significance-for-Primary-Endpoint-and-All-Secondary-Endpoints-in-Phase-3-INVIGORATE%E2%80%912-Trial-of-Reproxalap-in-Allergic-Conjunctivitis
