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The company recently completed enrollment in four separate phase II studies evaluating the drug as a treatment for DME, neovascular (wet) age-related macular degeneration (AMD), and dry eye syndrome. The company plans to announce data from these studies in the first half of next year. Additionally, two phase I clinical trials of the drug in patients with DME and wet AMD have been completed. Findings from both studies, which included a total of 80 patients and tested two routes of administration—subconjunctival injection and intravitreal injection—demonstrated the drug to be safe and well-tolerated in all doses tested, according to the company. Investigators from both studies also noted improvements in visual acuity consistent with observed beneficial anatomic changes following a single administration of the drug via either route. With the fast-track designation, MacuSight will be able to submit portions of a new drug application (NDA) for its sirolimus formulation as they are completed instead of filing all completed portions of the NDA at one time. As a result, the agency may begin its review of the application as portions are received, potentially accelerating the review and approval process. |   Practice Tools Coding Counselor Simple and accurate ICD-9 code search. Start Here  Formulary Counselor Find health plan drug coverage in your area. Start Here  Patient Education Print customized patient education handouts. Start Here  Surgical Video Center On-demand surgery demos and presentations. Start Here    
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