- Organizations: Aldeyra Therapeutics
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Aldeyra resubmits reproxalap NDA for dry eye (again)
Company includes new phase 3 dry eye crossover data in updated submission package; an FDA acknowledgement response is expected within 30 days.
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Aldeyra to resubmit reproxalap NDA following positive phase 3 data
Company reports statistically significant findings supporting the potential DED treatment after last month’s FDA-issued CRL.
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FDA rejects Aldeyra's reproxalap NDA for a second time
Agency states the candidate failed to demonstrate efficacy in treating ocular symptoms associated with dry eyes; company plans for a third submission.Pipeline
FDA accepts Aldeyra's reproxalap DED NDA resubmission
With a new PDUFA data set for April 2024, the company also announced expansions to its option agreement with AbbVie.
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Aldeyra resubmits reproxalap NDA for DED
Submission includes recent data from phase 3 dry eye chamber trial supporting the candidate’s acute and chronic activity in reducing symptoms.
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Aldeyra reports positive phase 3 data on reproxalap for DED
Dry eye chamber trial meets primary endpoint in hopes of supporting an FDA NDA resubmission by the end of 2024.
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Enrollment concludes in phase 3 reproxalap trial for DED
Pending positive data outcomes, Aldeyra plans to resubmit a new drug application to the FDA for the RASP inhibitor eye drop.
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Aldeyra to resubmit NDA for reproxalap DED treatment
Company plans to initiate a dry eye chamber trial four months after the FDA voiced concerns over the candidate’s clinical efficacy.Pipeline
Aldeyra's NDA for reproxalap requires more studies, FDA says
Complete response letter follows the submission of a special protocol assessment for a crossover trial.
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Aldeyra and AbbVie agree to exclusive licensing option for reproxalap
Agreement follows FDA concerns regarding the DED investigational compound’s clinical data.
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Aldeyra's reproxalap faces FDA concerns
Agency identifies substantive review issues with the dry eye disease candidate
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Aldeyra reports positive topline data from RP trial on ADX-2191
The preservative-free intravitreal formulation has already received orphan drug designation from the FDA.
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FDA determines Aldeyra's ADX-2191 NDA submission lacks substantial evidence of effectiveness
Designed for PVRL, the investigational drug candidate was granted priority review in March 2023.
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Topline data reported for reproxalap in phase 3 trial on allergic conjunctivitis
INVIGORATE-2 trial shows statistical significance for all primary and secondary endpoints.
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Aldeyra’s ADX-2191 NDA receives FDA priority review
Investigational drug candidate is designed for the treatment of primary vitreoretinal lymphoma.
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Aldeyra reports positive data in 12-month reproxalap trial for DED
Clinical results follow the FDA’s recent NDA acceptance for the topical ocular therapy.
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FDA accepts Aldeyra’s NDA for reproxalap for DED
A PDUFA target action date has been set for later this fall.
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Aldeyra submits NDA for primary vitreoretinal lymphoma treatment
ADX-2191 has already received Orphan Drug and Fast Track designation from the FDA.
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