Abstract
Purpose:
In the combined phase 3 clinical trials to assess safety and efficacy of ocriplasmin intravitreal injection (TG-MV-006 and TG-MV-007), 26.5% of ocriplasmin-treated patients achieved the study’s primary end point, which was pharmacologic resolution of VMA. Some post-marketing case series have reported higher efficacy rates, highlighting the importance of proper patient selection. This study tracked overall rates of VMA resolution and associated anatomic and visual acuity outcomes in patients treated with ocriplasmin.
Methods:
This was a retrospective efficacy and safety study in which patients with OCT-confirmed VMA and associated symptomatology were administered a single intravitreal injection of ocriplasmin. Baseline patient and ocular characteristics were recorded for future post-hoc analysis and included age, sex, lens status, visual acuity (VA), symptoms, presence of epiretinal membrane, size of adhesion, presence and size of macular hole (MH), and central retinal thickness. In patients without baseline MH, we evaluated the rate of VMA resolution up to the last day of follow-up. In patients with baseline MH, VMA resolution and FTMH closure were evaluated.
Results:
Twenty patients were treated: the rate of VMA resolution in patients without baseline MH was 42% (5/12), and the MH closure rate was 38% (3/8). Average age for patients with VMA resolution was 80.2 years, average greatest linear dimension (GLD) was 145 µm, average duration of symptoms was 4.5 months, and average improvement in VA was 2 lines. For patients without VMA resolution, averages were 77.8 years, GLD was 218 µm, duration of symptoms 3.3 months, and VA improvement was 0.33. For patients with MH at baseline and with hole closure, average age was 71.7 years, average linear dimension of base of hole was 93 µm, average duration of symptoms was 0.92 months, and average improvement in VA was 2.3-lines. Averages for patients without hole closure were 70.1 years, linear dimension of base of hole was 153 µm, symptoms for 2.7 months, and decrease in VA of 0.25. Additional analysis is ongoing and will be presented.
Conclusions:
Treatment with a single intravitreal injection of ocriplasmin was effective in symptomatic VMA patients with or without FTMH at baseline, and results from this study will help inform physicians and patients on what to expect after treatment with ocriplasmin.
Keywords: 585 macula/fovea •
586 macular holes •
692 retinal adhesion