A phase 3 trial of Aldeyra Therapeutics’ dry eye disease prospect has hit its primary endpoint, preparing the biotech to seek approval for a candidate the FDA has rejected twice in recent years. Another phase 3 trial missed its primary endpoint, but Aldeyra said the data can still support its latest resubmission.
Aldeyra first filed for FDA approval of reproxalap, which binds reactive aldehyde species, back in 2022. After the FDA demanded at least one additional symptom trial, the biotech started three studies and filed for approval again when the first readout was positive. The agency rejected the second submission in April and asked for positive data from at least one additional adequate and well-controlled study.
The biotech shared top-line data from two studies after the market closed Monday, May 5. The dry eye chamber trial found reproxalap was statistically superior to the control on the primary endpoint, which looked at ocular discomfort.
Aldeyra included data from another dry eye chamber trial in its second approval submission, but the FDA raised concerns about a baseline difference across treatment arms. The company said there were “no notable differences in baseline scores across treatment arms” in the second dry eye chamber trial and, as such, the study could potentially address the feedback the FDA shared in its complete response letter.
Aldeyra plans to resubmit its approval application in mid-2025 and expects a six-month FDA review. The biotech is preparing to include data from the second dry eye chamber trial and from a recently finished field trial. Aldeyra shared top-line data from the field trial Monday, saying the trial was “numerically supportive of reproxalap and consistent with prior field trials, [but] did not reach statistical significance.”
Draft FDA guidance states that chamber trials, which regulate temperature, air flow, humidity and other variables, and traditional environmental exposure studies can be acceptable in dry eye filings. Yet, there are no chamber data on the labels of the current crop of dry eye disease drugs. Aldeyra CEO Todd Brady, M.D., Ph.D., set out the pros and cons of relying on chamber data on a conference call with analysts in April.
“It might be easier for the FDA to approve a drug based on a field trial simply because that's been the standard in the past. But I think there are advantages to having dry eye chamber data on our label,” Brady said. “I think our label would be compelling with either an additional field trial or a dry eye symptom trial from a dry eye chamber on the label.”