Session Title: New drug treatment and technology
Session Date/Time: Friday 27/09/2013 | 14:30-16:00
Paper Time: 15:10
Venue: Hall 3 (Level 0)
First Author: A.Gandorfer GERMANY
Ocriplasmin has been submitted to the European Medicines Agency for use as a pharmacologic vitreolytic agent in the treatment of patients with vitreomacular traction, including when associated with macular hole. In the ocriplasmin MIVI-TRUST program, which included two phase 3, multicenter, randomized, double-masked trials, significantly more patients in the ocriplasmin group achieved pharmacologic resolution of vitreomacular adhesion (VMA) at postinjection day 28 compared with the placebo group (26.5% vs 10.1%; p<0.001). In order to help clinicians maximize the benefit of ocriplasmin therapy we sought to identify baseline factors that are predictive for VMA resolution.
A total of 652 subjects were included in the ocriplasmin phase 3 MIVI-TRUST program. Subjects had OCT-confirmed VMA with associated symptomatology at baseline.
A post-hoc multivariate regression analysis was performed using the MIVI-TRUST data to identify independent baseline predictors associated with VMA resolution at postinjection day 28 (primary end point). We then conducted a subpopulation analysis to determine rates of pharmacologic VMA resolution at day 28 in specific groups, which were defined by the number and combination of these predictive features present at baseline.
Independent baseline features predictive of VMA resolution at day 28 included age <65 years (p<0.001), presence of full-thickness macular hole (p=0.019), VMA diameter ≤1500 µm (p<0.001), absence of epiretinal membrane (p<0.001), and phakic lens status (p<0.001). Within each subgroup, patients treated with ocriplasmin showed a greater percentage of VMA resolution at day 28 compared to the placebo group.
Identification of baseline features associated with response may aid physicians in selecting patients who are most likely to respond to treatment with ocriplasmin. Future prospective analyses are needed to validate these findings.