Bayer HealthCare and Regeneron Pharmaceuticals say that two Phase III studies testing VEGF Trap-Eye (aflibercept ophthalmic solution) in wet age-related macular degeneration (AMD) met the primary endpoint of statistical noninferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab.
The goal of these studies was to demonstrate that VEGF Trap-Eye could improve vision and maintain this improvement over time with a more convenient every-other-month dose. The VIEW 1 study randomized 1,217 patients and is being conducted in the U.S. and Canada by Regeneron. The VIEW 2 study randomized 1,240 patients and is being conducted in Europe, Asia Pacific, Japan, and Latin America by Bayer HealthCare.
Patients receiving VEGF Trap-Eye 2 mg monthly achieved a statistically significant greater mean improvement in visual acuity at week 52 versus baseline (secondary endpoint) compared to ranibizumab 0.5 mg monthly. All other dose groups of VEGF Trap-Eye in the VIEW 1 study and all dose groups in the VIEW 2 study were not statistically different from ranibizumab in this secondary endpoint.
In the second year of the studies, patients in VIEW 1 and VIEW 2 will continue to be treated with the same dose per injection as in the first year but administered only every three months or more often for any worsening of AMD.
Further results will be presented at the Angiogenesis Conference in February 2011. Bayer and Regeneron are planning to submit regulatory applications in Europe and the U.S. in the first half of 2011 based on the positive results of these two trials.
Ninety-six percent of patients in the VIEW 1 study receiving VEGF Trap-Eye 0.5 mg monthly, 95% of patients receiving the 2 mg monthly dose, and 95% of patients receiving the 2 mg dose every two months achieved maintenance of vision compared to 94% of patients receiving ranibizumab 0.5 mg dosed every month.
Ninety-six percent of patients in the VIEW 2 trial receiving VEGF Trap-Eye 0.5 mg monthly, 96% of those receiving the 2 mg monthly dose, and 96% of patients receiving 2 mg every two months achieved maintenance of vision compared to 94% of patients receiving ranibizumab 0.5 mg dosed every month.
“The currently available anti-VEGF therapies have significantly advanced the treatment of wet AMD, actually improving vision in many patients,” says Ursula Schmidt-Erfurth, M.D., principal investigator of the VIEW 2 study.
“However, monthly injections are required to optimize and maintain vision gain over the long-term.
“The results of the VIEW studies indicate that VEGF Trap-Eye could establish a new treatment paradigm for the management of patients with wet AMD—predictable every-other-month dosing without the need for intervening monitoring or dosing visits.”
A generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab. The incidence of ocular treatment-emergent adverse events was balanced across all four treatment groups in both studies, with the most frequent events associated with the injection procedure, the underlying disease, and/or the aging process, the firms report.
The most frequent ocular adverse events were conjunctival hemorrhage, macular degeneration, eye pain, retinal hemorrhage, and vitreous floaters. The most frequent serious nonocular adverse events were typical of those reported in this elderly population who receive intravitreal treatment for wet AMD, Bayer and Regeneron state. The most frequently reported events were falls, pneumonia, myocardial infarction, atrial fibrillation, breast cancer, and acute coronary syndrome.