Reproxalap meets endpoints in phase 3 allergic conjunctivitis trial
Aldeyra Therapeutics has released positive topline results from a phase 3 clinical trial investigating reproxalap in patients with allergic conjunctivitis, according to a press release.
The INVIGORATE trial achieved statistical significance for the primary and secondary endpoints for 0.25% reproxalap ophthalmic solution. The results align with previous phase 2 and phase 3 trials for indications such as dry eye disease. Ninety-five patients with allergic conjunctivitis were enrolled in the randomized, double-masked, vehicle-controlled, two-way crossover design allergen chamber trial.
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For the primary endpoint of change from baseline in subject-reported ocular itching score, patients treated with reproxalap had a statistically significant score reduction over 11 time points compared with vehicle (P < .0001). They also had statistically significant improvement in secondary endpoints including ocular redness score, patient-reported ocular tearing score and total ocular severity score (all P < .0001).
“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 the release.
There were no observed safety or tolerability issues in the trial, and the only adverse event was “mild and transient instillation site discomfort.”
Aldeyra plans to discuss the trial results and the potential submission of a new drug application with the FDA later this year.
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