- The approval is based on two P-III ARTEMIS studies (including 8mos. extended follow up) assessing Durysta (10mcg) vs topical timolol drops (bid) in 1,122 patients with OAG & OHT.
- The two P-III ARTEMIS studies resulted in a 30% reduction in IOP from baseline in 12wks. primary efficacy period, meeting the predefined criteria for non-inferiority
- The approval expands the availability of Allergan’s EyeCue, a reimbursement service for eye care professionals facilitating the patient benefit verification & PA assistance for Allergan Eye Care products. Durysta is a prostaglandin analog, being evaluated in 5 P-III studies that support its FDA label enhancement & ROW approvals
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