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At 6 months after treatment, ocriplasmin increases the odds of vitreomacular adhesion resolution (VMAR), macular hole (MH) closure, and a >10 letter gain in best-corrected visual acuity (BCVA), while reducing the odds of vitrectomy, according to a study published in Survey of Ophthalmology.
Ocriplasmin is an enzyme used for the treatment of vitreomacular traction (VMT), with or without full-thickness MH. In this systematic literature review, researchers sought to examine important clinical outcomes of a single-dose intravitreal injection of ocriplasmin for the treatment of adults with VMT with or without MH.
The review included the following 5 randomized controlled trials (RCTs): the dose-ranging MIVI-IIT trial (ClinicalTrials.gov identifier: NCT00435539), the pivotal MIVI 006 (NCT00781859), the MIVI 007 (NCT00798317) trials, and the longer-term OASIS trial (NCT01429441). The fifth trial was classified as unpublished and named J-12-075 (NCT01889251). Between July 2013 and September 2014, the study was performed in Japan. All 5 trials excluded individuals if they had proliferative diabetic retinopathy, neovascular age-related macular degeneration, retinal vascular occlusion, aphakia, high myopia, uncontrolled glaucoma, vitreous opacification, lenticular or zonular instability, or a history of retinal detachment.
A total of 1067 participants were derived from the 5 RCTs, 737 (69.1%) were randomly assigned to ocriplasmin and 330 (30.9%) were randomly assigned to control. Of those assigned to control, 188 (57.0%) were assigned to placebo.
The researchers note that, 6 months following treatment, ocriplasmin achieved higher rates of VMAR and MH closure and lowered vitrectomy odds compared with control. From baseline to month 6, ocriplasmin treatment significantly increased the odds of a >10 letter gain in BCVA when vitrectomy was not present; the unadjusted OR for the overall study population was 2.60 (95% CI: 1.77 to 3.82).
Higher VMAR rates were associated with younger participants, women, and eyes with MH. Lower VMAR rates were associated with participants who had epiretinal membrane (ERM), broad vitreomacular adhesion (VMA) (>1500 μm), diabetic retinopathy, or pseudophakia.
Ocriplasmin-treated participants had more transient visual impairment vs those in the control group. However, visual impairment with onset during the first week recovered in 86.3% of participants and was not associated with worse BCVA outcomes. Ocriplasmin-treated participants also experienced more vitreous floaters, photopsia, photophobia, eye pain, blurred vision, and dyschromatopsia. The most frequent significant adverse events for ocriplasmin and control were MH progression (22.5%, 17.3%), new MH (1.5%, 3.4%) and retinal detachment (0.8%, 1.2%).
A limitation of the meta-analysis was the relatively small sample size given the binary nature of most endpoints.
“Early-onset visual impairment was common after ocriplasmin treatment, but not associated with worse BCVA outcomes,” the investigators report. “Patients who are candidates for ocriplasmin treatment should be counseled on the possibility of this adverse reaction and reassured that it is not predictive of long-term visual acuity outcomes.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. This research was supported by Oxurion NV (formerly ThromboGenics). Please see the original reference for a full list of authors’ disclosures.
Reference
Jackson TL, Haller J, Blot KH, Duchateau L, Lescrauwaet B. Ocriplasmin for treatment of vitreomacular traction and macular hole. Surv Ophthal. Published online September 1, 2021. doi:10.1016/j.survophthal.2021.08.003
