Phase 3 Trial Updates of Ocriplasmin for Vitreomacular Traction and Macular Holes
ThromboGenics announced data from two Phase 3 clinical trials evaluating ocriplasmin for the treatment of vitreomacular traction (VMT) and macular holes. The studies highlight that a single intravitreal injection of ocriplasmin resolved Vitreomacular Adhesion (VMA), releasing traction and closing macular holes in significantly more patients than placebo. VMT is also referred to as symptomatic Vitreomacular Adhesion.
The two multicenter, randomized, double-blind Phase 3 trials with ocriplasmin involved 652 patients with VMA. Both studies met the primary endpoint of pharmacological resolution of VMA at Day 28. Secondary endpoints included nonsurgical closure of a macular hole at 28 days, avoidance of vitrectomy (surgery) and improvement in visual acuity.
The Phase 3 program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (P<0.001). Nonsurgical closure of macular holes occurred in 40.6% of ocriplasmin-treated patients, compared with 10.6% of patients on placebo (P<0.001). Patients given ocriplasmin were more likely to achieve a vision gain of at least three lines compared with placebo.
Ocriplasmin is a truncated form of the human serine protease plasmin that retains its enzymatic properties and is believed to primarily target the fibronectin, laminin, and type IV collagen fibers that adhere the vitreous to the retina.
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