Aldeyra Therapeutics has just shared results for its phase 3 trial, the INVIGORATE-2, under which the biotech compared its drug reproxalap to a placebo to determine its effectiveness in reaching 11 predefined primary endpoints.
The trial for the allergic conjunctivitis treatment enrolled over 130 participants who were exposed to allergens in a chamber for between 110 and 210 minutes after either receiving reproxalap, a 0.25% reproxalap ophthalmic solution, or a placebo.
The results from the trial revealed that patients treated with reproxalap showed statistically significant reductions in the score of eye itchiness across all 11 primary endpoint comparisons.
Reproxalap is essentially a small-molecule drug used to hinder the activity of aldehyde species. Elevated levels of these species are present in patients with ocular and systemic inflammatory diseases.
In terms of achieving meaningful secondary endpoints, reproxalap-treated patients also showed significantly less eye redness compared to the placebo cohort. Additionally, the drug was able to achieve two other secondary endpoints, including a change in the total ocular score taking into account redness, tearing, itching, and a lower number of cases of ocular tearing.
No major safety or tolerability concerns were raised in the trial, and at most, mild and transient instillation site irritation constituted the worst of the adverse effects. No patients were forced to leave the treatment due to safety concerns.
This trial corroborated data collected from other trials such as the phase 3 ALLEVIATE and INVIGORATE trials, which also found the treatment to be effective in treating allergic conjunctivitis.
According to CEO Todd Brady, M.D., Ph.D., “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, the 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.”
It hasn’t always been smooth sailing for reproxalap. In a late-phase trial in 2021, the drug failed to meet the primary endpoint of ocular redness, but Aldeyra was fortunately able to make a swift recovery after it changed the trial endpoint to tear production, a goal it quickly met.
It was towards the end of last year that Aldeyra Therapeutics filed for FDA approval for reproxalap as a treatment for dry eye disease, and the agency is now set to announce the verdict for the drug in November of this year.
If approved, the treatment will benefit allergic conjunctivitis patients who are not adequately catered to by current medication. Approximately 50% of dry eye disease patients also suffer from ocular allergy, and reproxalap can benefit these patients, Brody explained.
Once approved, the drug will have to compete with already existing treatment models in the industry, including Novartis’ Xiidra, AbbVie’s Restasis, and other newer medications like Bausch + Lomb’s Miebo and Oyster Point Pharma’s Tyrvaya.
But before Aldeyra can start worrying about the agency’s decision on reproxalap, it is set to make a decision on Aldeyra’s primary vitreoretinal lymphoma treatment, ADX-2191. The verdict for this rare eye cancer treatment is said to come out next week.