The clinical trial successfully achieved statistical significance for the primary endpoint and all secondary endpoints.
Aldeyra Therapeutics announced positive top-line results from the phase 3 INVIGORATE-2 clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug, in patients with allergic conjunctivitis.
According to a press release from the company,1 “the clinical trial successfully achieved statistical significance for the primary endpoint and all secondary endpoints.”
Todd C. Brady, MD, PhD, President and CEO of Aldeyra, discussed the results in the press release.
“Consistent with the results of the Phase 3 INVIGORATE Trial and in conjunction with a number of successful Phase 2 and Phase 3 clinical trials in dry eye disease, achievement of the primary endpoint and all secondary endpoints in INVIGORATE-2 supports the potential of reproxalap as a treatment for inflammatory diseases of the ocular surface,” said Brady. “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.”
The phase 3 INVIGORATE‑2 Trial enrolled 131 allergic conjunctivitis patients. The primary efficacy endpoint was “change from baseline in patient-reported ocular itching score on a 0‑4 point scale over a majority of 11 timepoints from 110 to 210 minutes after allergen chamber entry,” according to the company. While the secondary endpoint was “change from baseline in ocular redness on a 0‑4 point scale over the duration of the allergen chamber (approximately 3.5 hours).”1
According to the results of the trial, “patients treated with reproxalap reported statistically significant ocular itching score reduction across all 11 prespecified primary endpoint comparisons (P<0.0001 for each comparison) from 110 to 210 minutes in the allergen chamber. The reproxalap-treated patients demonstrated statistically significant reduction from baseline compared to vehicle (P=0.004) for the key secondary endpoint of investigator-assessed ocular redness over the duration of the allergen chamber. Statistical significance was also achieved for the two secondary endpoints of change from baseline in patient-reported ocular tearing score on a 0‑3 point scale over the duration of the allergen chamber (P<0.0001) and change from baseline in total ocular severity score (11‑point composite of the itching, redness, and tearing scores) over the duration of the allergen chamber (P<0.0001).”1
William B. Trattler, MD, Vice Chair of Research and Associate Professor of Ophthalmology at Herbert Wertheim College of Medicine discussed the significance of the trial results in the press release.
“The co-morbidity of allergic conjunctivitis and dry eye disease poses diagnostic and treatment challenges to patients and healthcare providers.” said Trattler. “For patients who have had a poor response to over-the-counter ocular allergy medications, the data announced today may suggest that reproxalap could satisfy a substantial unmet need in patients who suffer from allergic conjunctivitis and dry eye disease.”
According to the company, reproxalap ophthalmic solution has now been administered to more than 2,400 patients across 21 clinical trials and a New Drug Application (NDA) of reproxalap for the treatment of dry eye disease is under review at the U.S. Food and Drug Administration. While the NDA Prescription Drug User Fee Act (PDUFA) date for reproxalap for the treatment of dry eye disease is set for November 23, 2023.