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    Lesion size plays key role in squalamine eye drops therapy

    Combination approach may lead to improved visual function in some AMD patients


    Impact Study

    The Impact Study included 142 patients with treatment-naïve wet AMD at 23 U.S. centers. Classic and occult CNV lesions were included in the study if they were less than 12 disc areas in size. Patients had vision ranging from 20/40 to 20/320 at baseline. Patients with diabetes who had no retinopathy were enrolled.

    One hundred and twenty-eight patients completed the 9 months of the study. If patients had any retinal cystic changes, retinal or subretinal fluid, and relevant retinal pigment epithelial elevations, they were re-treated, Dr. Boyer recounted.

    The primary end point of the study—i.e., a decreased number of injections in the active treatment group that received ranibizumab and OHR-102 drops compared with ranibizumab alone—was not met, he noted.

    “Benefits were seen in the secondary end points: the mean gain in visual acuity and the percentage of patients with 3, 4, and 5 lines or more of vision gained,” he said.

    Among the patients randomly assigned to combination therapy, they achieved 6 more letters of vision at the end of the study compared with those treated with ranibizumab monotherapy.

    When looking at the patients who gained 3 lines of vision or more, this increase started early in the study, as early as 12 weeks, and continued to a 57% improvement. This increase was also apparent for patients who gained 4 or more and 5 or more lines of vision.

    CNV Size

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