Use of Enzymatic Vitreolysis with Ocriplasmin for Treatment of Vitreomacular Traction and Macular Holes
Vitreomacular adhesion (VMA) can lead to pathologic traction and macular hole. The standard treatment for severe, symptomatic VMA is vitrectomy. Ocriplasmin is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface.
Researchers conducted two multicenter, randomized, double-blind, Phase III clinical trials to compare a single intravitreal injection of ocriplasmin (125 µg) with a placebo injection in patients with symptomatic VMA. The primary end point was resolution of VMA at day 28. Secondary end points were total posterior vitreous detachment and nonsurgical closure of a macular hole at 28 days, avoidance of vitrectomy, and change in best-corrected visual acuity (BCVA).
Overall, the researchers treated 652 eyes: 464 with ocriplasmin and 188 with placebo. They reported that VMA resolved in 26.5% of ocriplasmin-injected eyes and in 10.1% of placebo-injected eyes (p<0.001). They also found that total posterior vitreous detachment was more prevalent among the eyes treated with ocriplasmin than among those injected with placebo (13.4% vs. 3.7%, p<0.001). The study researchers achieved nonsurgical closure of macular holes in 40.6% of ocriplasmin-injected eyes, as compared with 10.6% of placebo-injected eyes (p<0.001). They noted that the BCVA was more likely to improve by a gain of at least three lines on the eye chart with ocriplasmin than with placebo. Furthermore, ocular adverse events (e.g., vitreous floaters, photopsia, or injection-related eye pain—all self-reported—or conjunctival hemorrhage) occurred in 68.4% of ocriplasmin-injected eyes and in 53.5% of placebo-injected eyes (p<0.001), and the incidence of serious ocular adverse events was similar in the two groups (p=0.26).
In conclusion, intravitreal injection of the vitreolytic agent ocriplasmin resolved vitreomacular traction and closed macular holes in significantly more patients than did injection of placebo and was associated with a higher incidence of ocular adverse events, which were mainly transient.