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

Dow Jones10-03

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 08:27 ET (12:27 GMT)

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