NEW ORLEANS — A greater proportion of patients receiving ocriplasmin achieved vitreomacular adhesion resolution at day 28, the primary endpoint of the MIVI-005 study, compared with patients receiving sham injections, a presenter said here.
Of the 100 patients in the double-masked multicenter study, 24.3% in the ocriplasmin group achieved VMA resolution compared with 12% in the sham group, Roger L. Novack, MD, PhD, FACS, said at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting.
“This was not statistically significant, but it’s important to note that this was a phase 2 proof-of-concept safety study and was not really powered to answer this question particularly,” Novack said.
The objective of the study was to evaluate safety and preliminary efficacy of a single intravitreal injection of 125 µg of Jetrea (ocriplasmin, ThromboGenics) in patients with wet age-related macular degeneration as well as vitreomacular adhesion. Patients were randomized 3:1 to the treatment group and the sham group.
“Ocriplasmin was generally well tolerated in patients with symptomatic VMA and exudative macular degeneration,” Novack said, adding that there were no additional safety signals.
“However, data from the current study do not demonstrate an additional clinically relevant benefit for the use of ocriplasmin in the treatment of symptomatic VMA in patients with concomitant macular degeneration. This is a population that had been excluded from the phase 3 studies,” Novack said.
Disclosure: Novack is a consult for Clarity Medical, a lecturer for Genentech, and a consultant and lecturer for Alcon.