To sNDA or NDA? Aldeyra clears a second PhIII for seasonal allergy eye drop
Aldeyra said its eye drop was better than the comparator at reducing ocular itching, redness and tearing, which means it has now cleared two Phase III trials for allergic conjunctivitis.
The drug is set to get an FDA decision by Nov. 23 in dry eye disease, with Aldeyra looking to go up against Novartis’ Xiidra and AbbVie’s Restasis. With new data on Thursday, Aldeyra CEO Todd Brady told analysts that the company thinks it has what’s needed for approval in allergic conjunctivitis. Now the biotech just has to decide whether to submit it as a supplemental NDA or carve out its own NDA.
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