A single intravitreal injection of ocriplasmin resulted in statistically significant improvement in vitreomacular traction and macular holes compared with placebo, according to a study.
Two multicenter, randomized, double-masked, placebo-controlled phase 3 trials examined 652 eyes; 464 eyes received a single intravitreal injection of 125 µg of ocriplasmin (ThromboGenics), and 188 eyes received placebo. Patients were assessed at baseline, on the day of injection, and at 7, 14, 28, 90 and 180 days after injection.
The primary endpoint was percentage of eyes with nonsurgical resolution of vitreomacular adhesion at 28 days. Secondary endpoints included percentage of eyes with total posterior vitreous detachment at day 28, closure of macular holes, need for vitrectomy and a gain of three or more lines of best corrected visual acuity.
At day 28, the proportion of patients with nonsurgical resolution of vitreomacular adhesion was significantly higher with ocriplasmin than with placebo in both trials. Overall, 26.5% of eyes treated with ocriplasmin reached the primary endpoint vs. 10.1% of eyes in the placebo group (P < .001).
Total posterior vitreous detachment at day 28 was noted in 13.4% of eyes injected with ocriplasmin compared with 3.7% of eyes injected with placebo (P < .001). Nonsurgical closure of macular holes was seen in 40.6% of ocriplasmin eyes vs. 10.6% of placebo eyes (P < .001).
Patients in the ocriplasmin group had fewer vitrectomies than the placebo group at 6 months, 17.7% vs. 26.6%, respectively. BCVA improved by three or more lines in 12.3% of ocriplasmin eyes vs. 6.4% of placebo eyes.
“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,” according to the authors of the study, which was supported by ThromboGenics.