Session Title: New drug treatment and technology
Session Date/Time: Friday 27/09/2013 | 14:30-16:00
Paper Time: 14:46
Venue: Hall 3 (Level 0)
First Author: T.Hassan USA
Ocriplasmin has been submitted to the European Medicines Agency as a pharmacologic vitreolytic agent for the treatment of patients with vitreomacular traction (VMT) and VMT associated with full-thickness macular hole (FTMH). In the phase 3 trials which supported this submission a number of patients experienced an increase in visual acuity of ≥2 lines at month 6 in the absence of achieving predefined anatomic endpoints or having a vitrectomy. We sought to determine if any other anatomic changes, outside of the pre-specified anatomic endpoints, could be driving this VA response.
The phase 3 ocriplasmin MIVI-TRUST clinical program was composed of two multicenter, randomized, double-masked, placebo-controlled trials designed to determine the efficacy and safety of ocriplasmin for the treatment of patients with VMT and VMT associated with macular hole.
For the purposes of this analysis we defined VA response as an improvement in visual acuity of ≥2 lines at month 6 in the absence of achieving pre-defined anatomic endpoints (VMA resolution at day 28 and FTMH closure by month 6) or having a vitrectomy. OCT scans from every study visit were analyzed for anatomic changes from baseline in VMA diameter, VMA status, FTMH minimal width, FTMH maximal width, cystoid macular edema, central retinal thickness, subretinal fluid, photoreceptor integrity, and other anatomic features.
VA response was achieved in 50 patients in the ocriplasmin arm and 12 patients in the placebo arm. The mean/median improvement in visual acuity was 14.3/12 letters (range 10-31) in the ocriplasmin group and 12.2/12 letters (range 10-17) in the placebo group. Additional OCT-analysis of VA responders is on-going and will be presented.
The proportion of patients in the MIVI-TRUST program with visual acuity improvements of ≥2 lines in the absence of achieving the pre-specified anatomic outcomes or having vitrectomy suggest that anatomic findings, other than those mentioned above, may result in VA response. Identifying these anatomic findings will help retina specialists more effectively manage ocriplasmin-treated patients with VMT and VMT associated with macular hole.