Aldeyra’s Phase III Data Show Positive Results for Eye Treatment

Pictured: A dry eye/Adobe Stock, Kryuchka Yaroslav

Pictured: A dry eye/Adobe Stock, Kryuchka Yaroslav

Thursday, biotech company Aldeyra Therapeutics announced statistically significant results from its Phase III trial of Reproxalap, a drug for treating allergic conjunctivitis and dry-eye disease.

Reproxalap is a liquid eye drop formulation of the small-molecule modulator of reactive aldehyde species (RASP). Aldehydes are present in elevated levels in ocular and systemic inflammatory disease and Reproxalap is designed to reduce their levels.

The top-line results from the Phase III INVIGORATE-2 Trial of 131 patients demonstrated statistically significant reductions in eye itchiness across the 11 primary endpoint comparisons for patients treated with either Reproxalap or a 0.25% Reproxalap ophthalmic solution. Patients were measured for between 110 and 210 minutes of exposure within an allergen chamber and treated or given a placebo before entering the chamber.

Patients demonstrated a reduction in eye redness and two secondary endpoints: a lower number of cases of ocular tearing and changes in total ocular score, encompassing redness, itching, and tearing.

Aldeyra said no patients ended their treatment due to any adverse reactions. No safety or tolerability concerns were noted, with the most common adverse reaction being mild and brief irritation at the installation site. Results from earlier this year also did not observe any of the primary endpoints of serious, treatment-related adverse events.

The results could pave the way for Aldeyra’s treatment to become an alternative to over-the-counter eye drops. Laidlaw & Company analyst Yale Jen said that if approved by the FDA, the drug will likely become the preferred prescription treatment for allergic conjunctivitis in patients who have already tried other over-the-counter medications without lasting results.

The results also suggest the drug has the potential for relevance in treating dry-eye disease. Oppenheimer analyst Justin Kim noted the market potential for Reproxalap in treating dry-eye disease would be significantly larger than for allergic conjunctivitis. The FDA is currently reviewing the drug as a treatment for dry-eye disease, and the agency is expected to decide by Nov. 23.

While these latest results add further evidence that Reproxalap may be an effective treatment for allergic conjunctivitis, the drug has had a somewhat less consistent track record in treating dry-eye disease. Phase III study results released in December 2021 showed the drug missing a primary endpoint, ocular redness. However, the drug hit a secondary endpoint, tear production, and Aldeyra modified its other Phase III trial, so a hit on either endpoint would constitute meeting the primary endpoint, which it did.

Shares of Aldeyra Therapeutics stock hit a high of at least $11.97 on Thursday, up from Wednesday’s closing price on the NASDAQ of $10.45.

Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.

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