Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, today announced that the first patient has been dosed in STRIDE 3 (Short Term Relief In Dry Eye), its Phase 3 trial of KPI-121 0.25% for the short-term treatment of dry eye disease.
“We are pleased to initiate the STRIDE 3 trial of KPI-121 0.25%. If approved, KPI-121 0.25% could be the first FDA-approved product for the short-term treatment of dry eye disease,” said Kim Brazzell, Chief Medical Officer. “The STRIDE 3 trial design reflects specific modifications to the inclusion/exclusion criteria of our previous trials to address key factors which we believe will improve the probability of success. We anticipate reporting topline results in the fourth quarter of 2019. We also continue to prepare for the potential approval and launch of INVELTYSTM (KPI-121 1%), which has been granted a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018, and which, if approved, is expected to be the first twice-daily ocular corticosteroid indicated for the treatment of post-operative ocular inflammation and pain.”
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.