Aerie Misses Quick Path To Dry Eye Approval, But Is Still Moving Forward
After Failing Phase IIb Study, Company Adds Phase III Trial
AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.
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Firm revises second Phase III trial for co-primary endpoints, possibly improving its chances of success for demonstrating efficacy on a sign of dry eye disease. Initial Phase III study missed ocular redness measure.
The Phase II trial showed significant improvement in eye redness in patients with dry eye disease, but additional data are needed on DED symptom improvement.
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