Aldeyra preps rebound bid for dry-eye hopeful reproxalap

2024-03-28

临床研究上市批准

Aldeyra Therapeutics is gearing up for a second chance at securing approval for its dry-eye disease drug reproxalap, bumping up shares by 12% on Thursday. The company announced plans to submit a new application for the topical RASP modulator in the second half, following a setback last year when the FDA found "substantive" issues with the filing and issued a complete response letter (CRL) citing lack of efficacy data.

The CRL requested at least one other "adequate and well-controlled study" to demonstrate the therapy's effectiveness on ocular symptoms linked to dry-eye disease. The rejection was all the more acute as Aldeyra had warned that its financial prospects hinged on US approval and successful commercial uptake of reproxalap.

The company says it now plans to initiate a pivotal dry-eye chamber clinical trial by June and refile its application in the second half. Based on FDA guidance, the review period for the resubmission is expected to take six months, putting a potential approval about a year behind the original PDUFA date.

The new trial, which will assess ocular discomfort as the primary endpoint, is expected to enroll about 100 patients. Aldeyra said its design and statistical powering are derived from four previously completed dry-eye chamber studies with reproxalap. "The planned clinical trial is expected to be more than 90% powered to detect a difference between treatment groups," according to the company.

Meanwhile, Aldeyra also plans to run a separate study at a different dry-eye chamber, as well as a traditional six-week field clinical trial, in parallel. This approach will help "account for disease heterogeneity and potential differences in clinical sites and environment," it said.

Aldeyra reiterated that its $142.8 million in cash and cash equivalents is "sufficient to fund operations beyond 2026."

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