OASIS trial: Ocriplasmin improves VMA resolution over long term

Ocriplasmin improved resolution of symptomatic vitreomacular adhesion, according to 2-year results of the OASIS trial.

The phase 3b randomized, sham-controlled, double-masked, multicenter clinical trial included 220 patients; 146 patients received intravitreal Jetrea 0.125 mg (ocriplasmin, ThromboGenics), and 74 patients received a sham injection. Patients were evaluated at 12 visits over 24 months.

Pravin U. Dugel

The primary efficacy endpoint was the proportion of subjects with pharmacologic resolution of VMA at 28 days. Secondary efficacy endpoints, assessed at 24 months, included the proportion of patients who gained best corrected visual acuity from baseline, experienced nonsurgical full-thickness macular hole closure and underwent vitrectomy, in addition to Visual Function Questionnaire scores.

The primary endpoint was achieved, with a VMA resolution rate of 41.7% in the ocriplasmin group and 6.2% in the sham group at 28 days. The between-group difference was statistically significant (P < .001). The treatment effect continued throughout the study period.

A two-line or greater improvement in BCVA was seen in 50.5% of patients in the ocriplasmin group and 39.1% of those in the sham injection group. Nonsurgical full-thickness macular hole closure was achieved in 30% of eyes in the ocriplasmin group and 15.4% of eyes in the sham group. Neither of these between-group differences were statistically significant.

Vitrectomy was performed in 33% of patients in the ocriplasmin group and 43% of those in the sham group (P = .08). VFQ-25 scores improved by five points or more from baseline, regardless of vitrectomy, in 51.4% of patients in the ocriplasmin group and 30.1% of those in the sham group (P = .003).

Adverse events tended to be mild to moderate and transient, with a short onset time. – by Matt Hasson

Disclosure: Dugel reports he has received personal fees from ThromboGenics and Alcon/Novartis. See the study for all other authors’ relevant financial disclosures.

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Source:

Dugel PU, et al. Ophthalmology. 2016;doi:10.1016/j.ophtha.2016.06.043.