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VA benefits noted in combined Fovista, Lucentis for wet AMD
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Researchers assessing the safety and efficacy of Fovista, a platelet-derived growth factor antagonist, administered with Lucentis, an anti-VEGF, for neovascular age-related macular degeneration found “a 62% additive improvement in mean change in VA from baseline to 24 weeks,” according to a study.
Researchers included 449 patients with treatment-naive neovascular AMD in the phase 2b global, multicenter, randomized, prospective, double-masked, controlled superiority trial. The patients were randomized in a 1:1:1: ratio to cohorts of Fovista (E10030, Ophthotec) 0.3 mg in combination with Lucentis (ranibizumab, Genentech/Roche) 0.5 mg, E10030 1.5 mg in combination with ranibizumab 0.5 mg or sham in combination with ranibizumab 0.5 mg. Patients received the drugs monthly for 24 weeks.
Researchers found patients who received 1.5 mg E10030 combination therapy had a statistically significant improvement in mean visual acuity of 10.6 ETDRS letters compared with a 6.5 ETDRS letter improvement in the anti-VEGF monotherapy cohort. Patients in the 0.3 mg E10030 combination therapy experienced an 8.8 ETDRS letter improvement at 24 weeks.
“This phase 2b study demonstrated a statistically significant VA benefit when E10030 (1.5 mg) was added to a monthly anti-VEGF regimen (E10030 combination therapy) over 6 months,” the researchers wrote, adding, “The relative treatment benefit in the E10030 combination therapy arm was evident regardless of baseline VA, lesion size or central subfield thickness on OCT, and was evident across multiple clinically relevant treatment end points measuring VA gain and reduction of VA loss.”
Disclosure: Jaffe reports he is a consultant for Alcon Laboratories/Novartis, Genentech/Roche, Neurototech and Heidelberg Engineering. Please see the full study for a list of all other authors’ relevant financial disclosures.
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Jaffe GJ, et al. Ophthalmology. 2016;doi:10.1016/j.ophtha.2016.10.010.
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