Alcon touts PhIII win for dry eye drug, plans mid-2024 FDA filing

Al­con is look­ing to file its top clin­i­cal can­di­date for FDA ap­proval mid-year af­ter clinch­ing pos­i­tive Phase III re­sults.

Its eye drop can­di­date, AR-15512, helped more peo­ple with dry eye dis­ease boost their tear pro­duc­tion at day 14 than place­bo. Al­though the com­pa­ny didn’t spell out the pro­por­tions of par­tic­i­pants who saw at least a 10-mm in­crease in unanes­thetized Schirmer’s score — mea­sur­ing tear pro­duc­tion with a pa­per strip — Al­con said the dif­fer­ence was sta­tis­ti­cal­ly sig­nif­i­cant (p<0.0001).

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