Aldeyra Therapeutics’ first foray into Phase III is a success, the eye drug developer said, setting it up for a potential NDA filing by the end of the year.
The top-line results in allergic conjunctivitis follow a similarly upbeat announcement last September that reproxalap made the cut in a Phase IIb for dry eye disease — a connection that Aldeyra made sure to highlight.
“Given that approximately half of allergic conjunctivitis patients also suffer from ocular dryness, we believe the ALLEVIATE results highlight the relevance of reproxalap to our current Phase 3 program in dry eye disease,” president and CEO Todd Brady said.
Investors seem to agree, rallying around its stock $ALDX, which is up 52%.
Two concentrations of the reproxalap solution — 0.25% and 0.5% — were tested in the 318-patient study alongside placebo, and both of them hit the primary endpoint: “ocular itch score (0 to 4 scale) area under the curve from 10 to 60 minutes after allergen challenge.” The statistically significant reductions came with p < 0.0001 and p = 00025, respectively.
The company also highlighted a statistically significant difference in two-point responder rates on the same itch score — a measure meant to confirm the clinical relevance of the drug.
While Aldeyra didn’t report on conjunctival redness — a secondary outcomes measure according to clinicaltrials.gov — it stated that mild and transient instillation site irritation was the only adverse events observed.
“There is a large allergic conjunctivitis patient population that is underserved by currently available medications,” CMO David Clark said. “The ALLEVIATE results suggest the potential of topical ocular reproxalap as a novel, safe, and effective therapeutic option that could be used to complement existing therapy before resorting to corticosteroids, which can lead to serious ocular toxicity.”
Reproxalap works by diminishing aldehyde levels, which can contribute to inflammation.
The goal now is to tie up all loose strings around a different clinical method that involves environmental exposure — rather than an allergen challenge chamber like this current study — and push ahead with new studies that might bolster its case in front of the FDA when Aldeyra meets with regulators in the second half of this year.
Aldeyra has secured a $60 million loan from Hercules Capital to fund all that — with a late-stage operation now going at full steam following a recent $10 million buyout of Helios Vision and its Phase III-ready drug.
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