Aldeyra Therapeutics has concluded the subject enrolment in its Phase III clinical trial of topical ocular 0.25% reproxalap, a new treatment for dry eye disease.
It enrolled a total of 132 subjects to evaluate the primary endpoint of ocular discomfort.
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The commencement of enrolment for this trial was previously announced last month.
The dry eye chamber trial aims to support a potential resubmission of a new drug application (NDA) in the second half of this year.
Reproxalap has shown promise in previous studies.
When combined data from four completed dry eye chamber clinical trials were analysed, the treatment demonstrated a statistically significant reduction in ocular discomfort compared to a vehicle.
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By GlobalDataAldeyra plans to propose a draft label in the NDA resubmission for reproxalap that highlights both chronic and acute symptom improvement, as well as a reduction in ocular redness.
If approved, this label could become the first for dry eye disease to include clinical data from an acute setting in a dry eye chamber and may also be the first to feature ocular redness reduction for a chronically administered medication.
In November last year, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Aldeyra Therapeutics regarding its new drug application (NDA) of reproxalap, requesting additional clinical trial data to show the drug’s efficacy.
The regulator indicated that the review period for the potential NDA resubmission should last six months.
Aldeyra is also conducting a separate Phase III trial in a different dry eye chamber and a standard six-week field clinical trial.
These concurrent studies are part of a comprehensive approach to address the variability in disease presentation and potential disparities in clinical site environments.
Aldeyra Therapeutics president and CEO Todd Brady said: “We believe the rapid enrolment of the Phase III clinical trial is consistent with the unmet medical need that exists for patients suffering from dry eye disease.
“We anticipate receiving results from the clinical trial in the third quarter of 2024, and, contingent on positive results, we remain on track to resubmit the dry eye disease NDA for reproxalap in the second half of 2024.”
