Aldeyra Plans Quick Response To FDA’s CRL For Reproxalap
Aldeyra already has a special protocol assessment under review at the FDA for a trial to provide the symptom data the agency said is needed for approval of the RASP modulator in dry eye disease.
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The US agency is reviewing two of the US biotech’s drug with decisions expected on its methotrexate product for ocular lymphoma by June and on the dry eye drug reproxalap in November, as Aldeyra mulls its marketing strategy for both.