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    Ocriplasmin in exudative AMD: Safety and efficacy results

     

    Ocular adverse events

    Among the most frequently reported ocular adverse events were visual acuity reductions, ocular pain, photopsia, and vitreous floaters—which was similar to the adverse events reported in the pivotal study of ocriplasmin, according to Dr. Novack.

    About 40% of patients treated with ocriplasmin in both studies reported an adverse event, as did about 21% of patients in the sham groups.

    In the MIVI-005 study, 3 patients who received ocriplasmin had a retinal detachment, 2 of which were not associated with the drug. Two patients had an episode of transient blindness associated with elevated IOP and resolved in about 1 hour.

    Summarizing the findings

    “A greater proportion of patients in the ocriplasmin group achieved the primary endpoint of resolution of VMA at day 28 after the injection compared to the sham group, said Dr. Novack, as he summarized the findings.

    Ocriplasmin was generally well tolerated in patients with symptomatic VMA and vitreomacular traction and exudative AMD. No additional safety signals were identified in the current study compared with the pivotal study of ocriplasmin.

    Data from this study do not show any additional clinically relevant benefit associated with the use of ocriplasmin in the treatment of symptomatic VMA/VMT in patients with exudative AMD. However, this population had been excluded from the phase III studies, he concluded.

     

    Roger L. Novack, MD, PhD

    E: rognov@laretina.com

    Dr. Novack has no financial interest in any aspect of this report.

     

     

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