Clinical-stage biotechnology company Aldeyra Therapeutics Inc. (ALDX:NASDAQ), which is engaged in developing novel therapies for patients with immune-mediated diseases, today announced "positive top-line results from the Phase 3 INVIGORATE Clinical Trial of 0.25% reproxalap ophthalmic solution (reproxalap), an investigational new drug, in patients with allergic conjunctivitis."
Aldeyra Therapeutics reported that reproxalap achieved statistical significance in the Phase 3 Trial meeting the primary and all secondary endpoints.
The company's President and CEO Todd C. Brady, M.D., commented, "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...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."
The firm indicated that the Phase 3 randomized study enrolled 95 participants diagnosed with allergic conjunctivitis. The predefined primary endpoint in the trial was change in subject-reported ocular itching and the key secondary endpoint was change in ocular redness over about 3.5 hours.
The company noted that "relative to patients treated with vehicle, patients treated with reproxalap reported statistically significant ocular itching score reduction over all 11 pre-specified primary endpoint comparisons," and in addition, "the reproxalap-treated patients demonstrated statistically significant reduction from baseline compared to vehicle (p<0.0001) for the key secondary endpoint of investigator-assessed ocular redness over the duration of the allergen chamber."
Milton Hom, O.D., of Canyon City Eyecare in Azusa, Calif., remarked, "Ocular allergy is a market that is ripe for innovation, and allergic conjunctivitis sufferers know it...Exacerbated by the rise in global temperatures, seasonal pollen counts are exploding, leading to escalations in the prevalence of allergic conjunctivitis and dry eye disease that are growing unchecked. Even with the availability of treatments over the counter, many patients are using more than one prescription to manage ocular symptoms and redness. Based on my review of the INVIGORATE data, reproxalap, as one of the first new therapeutic mechanisms of action in years, would be a meaningful complement to the current treatment paradigm for moderate-to-severe allergic conjunctivitis patients."
The company highlighted the results from several other reproxalap studies and explained that "in the Phase 3 ALLEVIATE Trial, 0.25% reproxalap demonstrated statistically significant reductions from vehicle in patient-reported ocular itching over one hour following direct topical conjunctival allergen challenge." The firm advised that reproxalap ophthalmic solution has now been studied in over 1,200 patients in 14 different clinical trials.
Aldeyra advised that it intends to meet with the U.S. Food and Drug Administration (FDA) in H2/21 to present and discuss the results from the INVIGORATE study and the grounds for submission of a New Drug Application (NDA).
The company explained that allergic conjunctivitis affects over 66 million people in the U.S. and greater than 1 billion people globally. The firm stated that allergic conjunctivitis symptoms of ocular itching and tearing are chronic and often painful and unrelenting.
Aldeyra Therapeutics is a clinical-stage biotechnology company based in Lexington, Mass., that focuses on developing new therapies for patients with immune-mediated diseases. The firm's drug pipeline candidates are geared toward inhibiting inflammatory cells that are linked to ocular and systemic conditions which are not presently being adequately addressed via existing treatments. Two of Aldeyra's lead investigational compounds are being developed to target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease. The company is presently studying reproxalap in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis and is also evaluating ADX-2191, which is a dihydrofolate reductase inhibitor, in Phase 3 testing for proliferative vitreoretinopathy.
Aldeyra Therapeutics began the day with a market capitalization of around $528 million with approximately 47.5 million shares outstanding and a short interest of about 9.8%. ALDX shares opened 16% higher today at $12.89 (+1.78, +16.02%) over yesterday's $11.11 closing price and reached a new 52-high price this morning of $15.17. The stock has traded today between $12.79 and $15.17 per share and is currently trading at $14.82 (+$3.71 +33.39%).
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