Phase 3 Trials of Ocriplasmin for Symptomatic Vitreomacular Adhesion
ThromboGenics NV announced new data from its pivotal ocriplasmin Phase 3 program including six month outcomes for the treatment of symptomatic vitreomacular adhesion (VMA) including macular holes. The study included new data confirming previous Phase 3 results that a single injection of ocriplasmin resolved VMA and associated visual symptoms in 29.8% of patients compared to 7.7% of patients on placebo (P=0.001). Six month follow up showed that 10.1% of patients gained three lines in visual activity compared to 5.1% on placebo. There were lower incidences of retinal tears or detachments in patients treated with ocriplasmin vs. placebo (1.7% vs. 4.3%).
Approximately 40.6% of patients with full thickness macular hole (FTMH) achieved closure compared with 17% on placebo (P=0.004). Approximately 58% of patients with FTMH smaller than 250micrometers saw closure compared to 20% on placebo. More patients gained ≥3 lines in visual acuity after six months of treatment with ocriplasmin compared to placebo (27% vs. 13%). Both Phase 3 trials met the primary endpoint of non-surgical resolution of focal vitreomacular adhesion one month after a single injection of ocriplasmin. Ocriplasmin is also being evaluated in Phase 2 clinical development for additional vitreoretinal conditions.
Ocriplasmin (microplasmin) 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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