Researchers from King’s College London, UK have published a systematic review and meta-analysis on individual participant data from RCT literature using evidence on ocriplasmin’s effect on vitreomacular adhesion resolution (VMAR), macular hole (MH) closure, vitrectomy, and best-corrected visual acuity (BCVA). Results of the analysis within five RCT studies, indicated that ocriplasmin achieved higher rates of VMAR and MH closure, versus control, lowered vitrectomy odds and increased the likelihood of a ≥10-letter BCVA increase. In addition, results of the study showed that VMAR rates were lower when epiretinal membrane (ERM), broad VMA (>1500 µm), diabetic retinopathy, or pseudophakia were present and higher in younger participants, women, and eyes with MHs. Ocriplasmin-treated participants experienced more short-term visual impairment that was not predictive of final BCVA, as well as vitreous floaters, photopsia, photophobia, eye pain, blurred vision, and dyschromatopsia.
Oxurion NV (formerly ThromboGenics NV, Brussels) ocriplasmin (or “Jetrea”) was approved by the US Food and Drugs Administration (FDA) (November 2012), and subsequently EMA (March 2013), for the treatment of symptomatic VMA. Pooled results were based on the “Microplasmin for Intravitreous Injection–Traction Release without Surgical Treatment (MIVI-TRUST)” studies (termed MIVI-006 and MIVI-007), double-blind randomized controlled trials (RCTs) with a primary endpoint of VMA resolution (VMAR) 28 days after injection without the creation of an anatomical defect (including MH) or the need for vitrectomy. According to the King’s College research team, the MIVI trials showed that ocriplasmin-treated participants had a higher chance of achieving VMAR than placebo-treated participants, as evidenced by an odds ratio (OR) of 2.56 (95% confidence interval [CI]: 1.32 to 5.24) in MIVI-006 and 5.13 (95% CI: 1.97 to 17.00) in MIVI 007. The randomized, sham-controlled “Ocriplasmin for Treatment of Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS)” study, showed similar results at 24 months follow-up milestone.
In the current systematic review and meta-analysis, the researchers commented that “the use of ocriplasmin in VMT (vitreomacular traction) or MH (full-thickness macular hole) have been based on aggregate data extracted from publications. These aggregate data represent a summary of the IPD for each study and do not offer the flexibility of comprehensive subgroup analyses. Using an IPD rather than aggregate data approach to a meta-analysis of RCTs facilitates the investigation of whether an intervention is more or less beneficial for different types of participants and can be more effective in reducing heterogeneity than meta-analyses that are limited to published data”. While this recent contribution provides an extremely valuable analysis, readers may be interested to review other additional reports on other data, including a previous systematic review and meta-analysis between pars plana vitrectomy to ocriplasmin, showing 92% macular hole closure after surgery compared to 34% after ocriplasmin treatment (Yu et al, Eur J Ophthalmol, 2021 Jul;31(4):2003-2012), and a “real-world” study, using a retrospective survey among members of the British and Eire Association of VitreoRetinal Surgeons (BEAVRS) study, finding “both a higher incidence of adverse events after ocriplasmin, and lower success rates for macular hole closure, than described in the phase 3 trials” (Haynes et al, Eye, 2017 Jan;31(1):107-112.