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Aerie Misses Quick Path To Dry Eye Approval, But Is Still Moving Forward

After Failing Phase IIb Study, Company Adds Phase III Trial

 
• By Joseph Haas

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.

Render illustration of Clinical Trial title on medical documents
Disappointing results from a Phase IIb study don't forestall Aerie's plans in dry eye

Shareholders remain unhappy with Aerie Pharmaceuticals, Inc.’s attempt to spin a failed Phase IIb study for its TRMP8 agonist AR-11512 in dry eye disease as a success. But since multiple endpoints were hit in the trial, the company is planning to move ahead with two Phase III trials and could still obtain US approval in an increasingly crowded therapeutic space.

Right after market closing on 15 September, Aerie announced that the 369-patient COMET-1 study of AR-15512 missed the predetermined primary endpoints of OSD-VAS, a symptom of dry eye disease, and anesthetized Schirmer’s score, a sign of the disease

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