Aldeyra Therapeutics Files Again for FDA OK of Dry-Eye Disease Treatment

By Colin Kellaher

Aldeyra Therapeutics has once again filed for Food and Drug Administration of its proposed reproxalap drug candidate for the treatment of signs and symptoms of dry-eye disease.

Aldeyra on Thursday said the resubmission includes results from a recently completed symptom trial the FDA requested late last year when the agency's turned away the Lexington, Mass., company's initial application.

The resubmission also includes a draft label reflecting acute activity in reducing dry-eye symptoms in a dry-eye chamber trial, chronic activity in reducing dry-eye symptoms in a field trial and acute activity in reducing ocular redness in two dry-eye chamber trials.

FDA guidelines call for an acknowledgment of acceptance for review within 30 days of a resubmission and completion of a review within six months.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

October 03, 2024 08:42 ET (12:42 GMT)

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