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.

To read Endpoints News become a free subscriber

Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters

SIGN UP LOG IN