The investigational new drug, 0.25% reproxalap ophthalmic solution (reproxalap; Aldeyra Therapeutics, Inc), achieved statistical significance for the primary endpoint and all secondary endpoints in the Phase 3 INVIGORATE Clinical Trial, according to a press release.
Patients with allergic conjunctivitis treated with reproxalap reported a statistically significant reduction in ocular itching score over prespecified primary endpoint comparisons from 110 to 210 minutes in the allergen chamber compared to those treated with vehicle. For the key secondary endpoint of change from baseline in ocular redness on a 0‑4 point scale over the duration of the allergen chamber, patients treated with reproxalap had a statistically significant reduction from baseline compared to vehicle.
Change from baseline in patient-reported ocular tearing score on a 0‑3 point scale over the duration of the allergen chamber and change from baseline in total ocular severity score (over the duration of the allergen chamber also achieved statistical significance.
“The statistically significant superiority of reproxalap over vehicle across all allergic conjunctivitis symptoms and signs assessed in INVIGORATE is remarkable, and suggests utility in one of the world’s most common ocular surface diseases,” Todd C. Brady, MD, PhD, President and CEO of Aldeyra, said in a company news release. “We believe the consistent activity observed across chamber models in allergic conjunctivitis and dry eye disease bodes well for the commercial positioning of reproxalap as potentially the only broadly applicable topical anterior segment immune-modulating drug that may be used for chronic treatment if approved for marketing.”
Read the full press release here.