Drug noninferior for AMD

Orlando-Two studies of a fusion protein (VEGF Trap-Eye, Regeneron) showed that all doses of the drug, including those administered every 2 months, to treat neovascular age-related macular degeneration (AMD) were noninferior to ranibizumab (Lucentis, Genentech) in the number of patients who maintained their visual acuity.

“When we deviate from the anti-vascular endothelial growth factor drug treatment regimens for treating neovascular AMD and treat less frequently, the outcomes are less robust compared with strict adherence to the treatment regimens,” said Jeffrey Heier, MD, of Tufts University School of Medicine, Boston. “We have an unmet medical need highlighted by the need to minimize treatment burden while maintaining treatment efficacy. Because of this, we anxiously awaited the results of the VIEW trials.”

The fusion protein blocks all isoforms of VEGF and placental growth factor.

VIEW 1, conducted in North America, and VIEW 2, conducted globally, were carried out simultaneously and included more than 2,400 patients who were randomly assigned to one of four treatment groups: VEGF Trap-Eye 0.5 mg monthly, 2 mg monthly, 2 mg every 2 months after receiving three initial monthly doses, or 0.5 mg of ranibizumab monthly. The primary endpoint was prevention of moderate vision loss at 1 year. In the second year of the study, the protocol calls for as-needed dosing to be administered with strict re-treatment criteria.

Dr. Heier said that the fusion protein was generally well tolerated and had a favorable safety profile for treating neovascular AMD.

“All groups of [the fusion protein] were noninferior compared with ranibizumab dosed monthly,” he said. “Regarding the mean improvement in the letter score, all four arms of the study were similar. The hope is to decrease the treatment burden for these patients and maintain excellent outcomes.”

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