Oculis says its eye drops passed an ear­ly PhI­II test. Re­searchers have to re­peat it to win ap­proval

A Swiss biotech fo­cused on de­vel­op­ing new eye treat­ments tout­ed pos­i­tive da­ta from the first part of a mul­ti-stage Phase III pro­gram Mon­day morn­ing.

Oculis said its eye drop for­mu­la­tion of the cor­ti­cos­teroid dex­am­etha­sone achieved both pri­ma­ry end­points in “Stage 1” of its Phase III tri­al in di­a­bet­ic mac­u­lar ede­ma, show­ing sta­tis­ti­cal­ly sig­nif­i­cant ef­fi­ca­cy at six and 12 weeks in two dif­fer­ent mea­sure­ments. “Stage 2” of the Phase III study will ex­am­ine the drug’s ef­fect out to 12 months, which Oculis said is re­quired for reg­u­la­to­ry ap­proval. That stage will be­gin in the sec­ond half of this year.

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