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)
Copyright (c) 2024 Dow Jones & Company, Inc.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。