Ocriplasmin promising option in VMA subgroup

May 9, 2012

Pharmacologic vitreolysis with a single intravitreal injection of 125 µg of ocriplasmin (ThromboGenics) resulted in vitreomacular adhesion (VMA) resolution at day 28 in about 30% of patients, and up to 40% in those with smaller zones of adhesion, compared with 7.7% in a placebo-treated group in a subgroup responder analysis of phase III MIVI-TRUST clinical trial data, said Baruch D. Kupperman, MD, PhD.

Fort Lauderdale, FL-Pharmacologic vitreolysis with a single intravitreal injection of 125 µg of ocriplasmin (ThromboGenics) resulted in vitreomacular adhesion (VMA) resolution at day 28 in about 30% of patients, and up to 40% in those with smaller zones of adhesion, compared with 7.7% in a placebo-treated group in a subgroup responder analysis of phase III MIVI-TRUST clinical trial data, said Baruch D. Kupperman, MD, PhD.

Patients also achieved a mean improvement in best-corrected visual acuity of 7.8 letters.

The outcomes of the analysis are promising, and this minimally invasive pharmacologic approach could offer a new and early treatment option for patients who normally would not be considered candidates for surgery, said Dr. Kupperman, a clinical investigator for study sponsor ThromboGenics and professor and chief of the retina service at the Gavin Herbert Eye Institute, University of California, Irvine.

The subgroup consisted of 266 eyes that had vitreomacular traction (excluding those that had concurrent macular hole or epiretinal membrane) at baseline from a total 652 eyes in two large clinical trials conducted in the MIVI-TRUST program; 188 were given the ocriplasmin injection and 78 received an injection of vehicle.

Patients were followed out to 6 months; by that point, 41% of treated patients had gained ≥2 lines of visual acuity and 14.3% had gained ≥3 lines.

“Many of these patients had quite good vision, and I think that’s an important feature of this study, since these are patients that we would not have typically considered for surgery, but this is a pharmacologic option,” Dr. Kupperman said.

Vision could be as good as 20/25 in the study eye.

Most ocular adverse events were transient and mild, such as floaters and photopsia, and were likely to occur within 7 days of treatment. A positive therapeutic response also was typically observed relatively quickly.

Ninety-five percent of the eyes that eventually had a response did so within 28 days, “so if this was something available and in use, there’s little point in waiting beyond 28 days for resolution if this is a patient for which you are considering surgery,” Dr. Kupperman said.

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