Bimonthly anti-VEGF regimen shows equivalent efficacy to monthly anti-VEGF regimen
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Ursula Schmidt-Erfurth |
VIENNA, Austria One-year study results of aflibercept showed equivalent efficacy with a fixed bimonthly regimen compared with a fixed monthly administration of ranibizumab in the treatment of neovascular age-related macular degeneration.
"This study did not only introduce a new pharmacological class into the treatment of AMD, but also significantly reduced the treatment burden for patients and health care givers," Ursula Schmidt-Erfurth, MD, said at the Advanced Retinal Therapy meeting here.
Eylea (aflibercept, Regeneron Pharmaceuticals), also known as VEGF Trap-Eye, underwent a large prospective phase 3 program that included 2,457 patients throughout North America, Europe, Asia, South America and Australia. Patients were randomized to aflibercept at a dosage of 0.5 mg or 2 mg every month, 2 mg every 2 months or the standard dose of Lucentis (ranibizumab, Genentech) every month.
All aflibercept dosing groups were equivalent to ranibizumab dosed monthly for maintenance of vision and gain of vision and best corrected visual acuity. The number of active injections in the monthly groups were 12.5 injections per year, while in the bimonthly treatment group patients received an average of 7.5 treatments per year. Central retinal thickness decreased in all groups on par with vision improvement.
"The study also provides a revival of the fixed regimen paradigm, which may be advantageous compared to the [as-needed] regimen. Re-treating as needed is perhaps the most appropriate concept, but we need to identify solid parameters for monitoring and re-treatment," Dr. Schmidt-Erfurth said.
- Disclosure: Dr. Schmidt-Erfurth served as an adviser or consultant for Alcon, Bayer HealthCare and Novartis Pharmaceuticals Corporation.