Awaiting FDA's decision, Aldeyra's dry eye disease drug scores phase 3 win for conjunctivitis

Aldeyra Therapeutics has notched up another phase 3 win for its allergic conjunctivitis treatment as the biotech awaits an FDA approval decision for dry eye disease.

The INVIGORATE-2 trial enrolled 131 patients who received either reproxalap, a 0.25% reproxalap ophthalmic solution or placebo and then entered a chamber where they were exposed to allergens. When compared to the placebo cohort, patients treated with reproxalap reported statistically significant reductions in a score of eye itchiness across all 11 primary endpoint comparisons when measured from between 110 and 210 minutes from exposure in the allergen chamber.

The reproxalap-treated patients also demonstrated a statistically significant reduction in eye redness while in the chamber when compared to the placebo group, hitting a key secondary endpoint. The drug also achieved two other secondary endpoints—a lower number of cases of ocular tearing and a change in total ocular score that spanned itching, redness and tearing.

There were no observed safety or tolerability concerns in the trial, the company added, with the most common adverse event being mild and transient instillation site irritation. No patients discontinued their treatment due to adverse events.

The latest results add to a growing body of evidence to back reproxalap’s effectiveness in allergic conjunctivitis, including the phase 3 ALLEVIATE and INVIGORATE trials.

It hasn’t all been smooth sailing for the candidate for treating dry eye disease, where reproxalap missed a primary endpoint of ocular redness in a late-phase trial in 2021. Undaunted, the biotech returned with a different trial endpoint on tear production, which it promptly hit.

“Consistent with the results of the phase 3 INVIGORATE Trial and in conjunction with a number of successful phase 2 and phase 3 clinical trials in dry eye disease, achievement of the primary endpoint and all secondary endpoints in INVIGORATE-2 supports the potential of reproxalap as a treatment for inflammatory diseases of the ocular surface,” CEO Todd Brady, M.D., Ph.D., said in the release.

“We believe that the rapid-onset activity of reproxalap evidenced in the INVIGORATE clinical trials may offer hope to allergic conjunctivitis patients who are today not adequately treated, and also to dry eye disease patients, up to 50% of whom suffer from ocular allergy,” Brady added.

Reproxalap is a small-molecule drug formulated as a solution that inhibits reactive aldehyde species, a substance that is associated with inflammation and is elevated in patients with ocular and systemic inflammatory disease. Aldeyra submitted an approval application to the FDA for reproxalap to treat dry eye disease toward the end of last year, with a decision date from the regulator penciled in for November.

Before that comes, the FDA is set to make a decision next week on ADX-2191, a treatment for a rare eye cancer called primary vitreoretinal lymphoma. 

The biotech ended March with $165 million in cash and equivalents, which the company estimates will be enough to launch both reproxalap and ADX-2191. If reproxalap wins approval, Aldeyra will then need to carve out a space among established incumbents such as AbbVie’s Restasis and Novartis’ Xiidra, as well as newer entrants like Oyster Point Pharma’s Tyrvaya and Bausch + Lomb’s Miebo.

Aldeyra’s stock opened up 6% at $11.10 this morning from a Wednesday closing price of $10.45 per share.