Aldeyra Therapeutics has concluded enrolment in the Phase III INVIGORATE-2 trial of its topical ocular reproxalap for the treatment of patients with allergic conjunctivitis.
Said to be the most common inflammatory disease, allergic conjunctivitis affects the front of the eye.
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A total of 131 patients with seasonal allergic conjunctivitis were enroled in the double-masked, crossover, randomised, vehicle-controlled trial.
Subjects were exposed with real-world pollen in an allergen chamber and evaluated for 3.5 hours.
Patient-reported ocular itching is measured as the primary endpoint of the trial.
Aldeyra president and CEO Todd Brady said: “Today, millions of allergic conjunctivitis patients rely on therapies that may not provide sufficient relief or cannot be used chronically due to serious side effects.
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By GlobalData“Reproxalap, which has demonstrated rapid and durable improvement in the symptoms and signs of allergic conjunctivitis across a number of clinical trials, could signify the first new therapeutic mechanism of action in decades for patients suffering from this persistently disturbing condition.”
Top-line results from INVIGORATE-2 are expected to be announced in the first half of this year.
Reproxalap, a small-molecule reactive aldehyde species (RASP) modulator, has been investigated in over 2,300 subjects and no clinically significant safety concerns were observed.
INVIGORATE-2’s protocol is substantially identical to that of the Phase III INVIGORATE and Phase II clinical trials. Both the trials achieved the ocular itching endpoint (P<0.001).
