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ORBIT study: Efficacy of ocriplasmin in resolving VMA linked to baseline features

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SAN FRANCISCO — Early data from the ORBIT study showed the efficacy of ocriplasmin in resolving vitreomacular adhesion according to certain baseline ocular characteristics, a speaker told colleagues here.

“Eyes had better resolution of vitreomacular adhesion if there was no epiretinal membrane, smaller amounts of vitreomacular adhesion and if a full-thickness macular hole was present,” Mathew W. MacCumber, MD, PhD, said at the American Society of Retina Specialists annual meeting.

Interim 6-month data from the ORBIT study compared well with those of the MIVI-TRUST studies, MacCumber said.

The MIVI-TRUST studies associated three baseline patient characteristics with the efficacy of Jetrea (ocriplasmin, ThromboGenics): absence of epiretinal membrane, focal adhesion smaller than 1,500 µm and presence of a full-thickness macular hole smaller than 400 µm.

ORBIT, a phase 4 prospective, multicenter, randomized study, included 540 patients with symptomatic VMA treated with ocriplasmin 0.125 mg.

Interim 6-month results showed overall VMA resolution in 29.4% of eyes at 1 week, 42.5% at 1 month and 50.6% at 6 months.

“This data is better than the MIVI-TRUST data, where at 1 month only 26.5% of eyes had VMA resolution,” MacCumber said. “There was also better resolution based on the size of the vitreomacular adhesion, with smaller amounts of adhesion having better resolution, with a percentage of 57.6% at 6 months for the smallest amounts.”

VMA resolved in 66.4% of eyes with a full-thickness macular hole and 44.2% of eyes without a full-thickness macular hole. VMA resolved in 81% of eyes with a full-thickness macular hole smaller than 250 µm and 58.6% of eyes with a full-thickness macular hole larger than 400 µm.

VMA resolution occurred in 56.5% of eyes with no epiretinal membrane and 39.2% of eyes with epiretinal membrane. – by Matt Hasson and Patricia Nale, ELS

Reference:

MacCumber M. ORBIT: a phase IV clinical study – lessons learned from patient selection criteria for ocriplasmin intravitreal injection. Presented at: American Society of Retina Specialists annual meeting; Aug. 9-14, 2016; San Francisco.

Disclosure: MacCumber reports financial relationships with Allergan, Covalent Medical, Genentech, Optos, Regeneron and ThromboGenics.