ThromboGenics has released six months data from a Phase III program evaluating ocriplasmin as a treatment of symptomatic vitreomacular adhesion (VMA) including macular holes.
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The new data showed that a single injection of ocriplasmin resolved VMA and the visual symptoms associated with it in 29.8% of VMT patients, compared with 7.7% of patients on placebo (28 days).
The results suggested that 10.1% of patients in the ocriplasmin arm gained three lines in visual acuity compared with 5.1% on placebo (6 month follow up).
The data from the trial evaluating ocriplasmin for the treatment of macular hole demonstrated that around 40.6% of patients with full thickness macular hole (FTMH) achieved closure compared with 17% on placebo.
Additionally, 58% of patients with FTMHs smaller than 250µm saw closure with ocriplasmin compared with just 20% in placebo patients.
In the trial, 27% of patients gained = 3 lines in visual acuity after six months of treatment with ocriplasmin, compared with 13% on placebo
Earlier in 2010, ocriplasmin completed two pivotal Phase III trials (TG-MV-006 and TG-MV-007) and met primary endpoint of non-surgical resolution of focal vitreomacular adhesion one month after a single injection of ocriplasmin.
ThromboGenics CEO Patrik de Haes said they remain on track to make regulatory filings for this novel compound in Europe and the US by the year-end.
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