Session Title: New drug treatment and technology
Session Date/Time: Friday 27/09/2013 | 14:30-16:00
Paper Time: 14:38
Venue: Hall 3 (Level 0)
First Author: B.Kuppermann USA
Ocriplasmin represents a novel therapeutic class and is the first pharmacologic agent available for the treatment of vitreomacular traction (VMT), including VMT associated with macular hole. Inevitably, there will be a learning curve associated with the utilization of ocriplasmin among the retina community. Given the range of disease symptomatology and patient phenotypes in the MIVI-TRUST program we sought to characterize the effect of ocriplasmin in patients where retina specialists are most likely to first use ocriplasmin, candidates for vitrectomy. Additionally, we will characterize the impact on vitrectomy in patients who received ocriplasmin but still required subsequent surgical invention.
The MIVI-TRUST program was composed of two multicenter, randomized, double-masked, placebo-controlled trials designed to determine the efficacy and safety of ocriplasmin for patients with VMT, including VMT associated with macular hole.
A total of 652 patients with OCT-confirmed VMA were randomized to receive a single intravitreal injection of 125 µg ocriplasmin (n=464) or placebo (n=188). A subpopulation was analyzed to investigate the efficacy of ocriplasmin in candidates for surgical intervention with vitrectomy. Clinical criteria for consideration for vitrectomy were visual acuity of less than 65 ETDRS letters (20/50) (n=286) or full-thickness macular hole (FTMH, equivalent to stage 2) (n=153) at baseline. There were 127 patients who met both criteria. The primary end point was pharmacologic resolution of VMA at postinjection day 28. Selected secondary end points included pharmacologic inducement of total posterior vitreous detachment (PVD) at day 28 and closure of FTMH at day 28.
Pharmacologic resolution of VMA at day 28 was observed in a significantly larger proportion of vitrectomy candidate eyes in the ocriplasmin group compared with the placebo group. Among the patients with a baseline BCVA of less than 65 letters, 33.2% of eyes treated with ocriplasmin achieved VMA resolution compared with 11.5% of eyes in the placebo group (p<0.001). The rates of pharmacologic inducement of total PVD at day 28 were 15.5%/22.6% (<65 letters/FTMH) in the ocriplasmin-treated groups and 5.1%/8.5% in the placebo-treated groups (p=0.015/p=0.033). In patients with baseline FTMH, 40.6% achieved pharmacologic closure in the ocriplasmin arm compared to 10.6% in the placebo arm (p<0.001). Vitrectomy was required less often in the ocriplasmin groups (29.0%/44.3%) versus the placebo groups (36.7%/57.4%) (p=0.272/p=0.157). Analysis of earlier phase II trials which studied ocriplasmin as an adjunct to surgery indicated that the stage of PVD at the time of planned vitrectomy was greater with preoperative ocriplasmin compared to placebo. In patients who proceeded to vitrectomy, mean maximum suction and mean surgical time required to induce total PVD were lower after treatment with ocriplasmin compared with placebo.
Treatment with a single intravitreal injection of ocriplasmin was effective in patients with VMT who would commonly be considered candidates for vitrectomy.