(HealthDay) -- Intravitreal injection of the vitreolytic agent ocriplasmin resolves vitreomacular traction and closes macular holes significantly better than placebo, but with a higher incidence of adverse events, according to a study published in the Aug. 16 in the New England Journal of Medicine.
Peter Stalmans, M.D., Ph.D., from the Universitaire Ziekenhuizen Leuven in Belgium, and colleagues compared a single intravitreal injection of ocriplasmin with a placebo injection in two randomized phase 3 clinical trials involving patients with symptomatic vitreomacular adhesion.
The researchers found that 464 eyes were treated with ocriplasmin and 188 with placebo. Vitreomacular adhesion was resolved in significantly more ocriplasmin-injected eyes than placebo-injected eyes (26.5 versus 10.1 percent). The prevalence of total posterior vitreous detachment was significantly increased in ocriplasmin- versus placebo-injected eyes (13.4 versus 3.7 percent). In 40.6 percent of ocriplasmin-treated eyes and 10.6 percent of placebo-treated eyes, nonsurgical closure of macular holes was achieved. A gain of at least three lines on the eye chart in best-corrected visual acuity was more likely in ocriplasmin- versus placebo-treated eyes. Adverse events were seen in 68.4 and 53.5 percent of ocriplasmin-injected and placebo-injected eyes, respectively (P < 0.001), but the incidence of serious ocular adverse events was similar in the groups (P = 0.26).
"In conclusion, our study shows that enzymatic vitreolysis represents a means to resolve vitreomacular traction and to close macular holes," the authors write. "Intravitreal injection of ocriplasmin was superior to injection of placebo in altering the vitreoretinal interface of affected eyes, although it was accompanied by some, mainly transient, ocular adverse events."
The study was funded by ThromboGenics, which manufactures ocriplasmin; several authors disclosed financial ties to pharmaceutical and biotechnology companies, including ThromboGenics.
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