Regeneron (Nasdaq: REGN) and Bayer HealthCare announced initiation of a new Phase 3 clinical trial in collaboration with the Singapore Eye Research Institute (SERI) investigating the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia. The trial has started in Japan and other Asian countries, including China, Korea, Singapore, and Taiwan.
Myopia is one of the most common eye conditions and is highly prevalent in Asian populations, including Singapore where 40% of adults have myopia and nearly 10% have high myopia. Myopic CNV is a complication of high myopia where abnormal blood vessels grow and leak blood and fluid into the retina as a result of degenerative changes in the retinal lining of the eye and is a potentially blinding condition. Currently, there is no well-established treatment for myopic CNV. VEGF Trap-Eye has previously met its primary efficacy endpoint in a Phase 3 trial for neovascular (wet) age-related macular degeneration (AMD).
Collaboration with the Singapore Eye Research Institute (SERI)
SERI has been appointed as the Asian reading center partner for this study. The Singapore Advanced Imaging Laboratory for Ocular Research (SAILOR) will serve as the first reading center for VEGF Trap-Eye studies in the region. SAILOR brings together an inter-disciplinary group of clinician researchers and scientists to collaborate on cutting-edge computer image research. SAILOR is the first clinical translational research unit to be located in Fusionopolis, a research and development complex in Singapore, and serves as a hub of translational research programs in ocular imaging among clinicians, scientists, computer scientists, and other experts. One of the major programs SAILOR has developed is a "tele-ophthalmic ocular imaging platform" to allow transfer and data capture of ocular images for diagnosis and screening. SAILOR will read the images for this myopic CNV trial from the different Asian sites.
"Myopia is a common problem in Singapore and Asia. In particular, myopic CNV, which affects certain groups of people with higher degrees of myopia, may lead to vision loss. There remains uncertainty regarding the best methods of treatment for myopic CNV and this new trial will go towards addressing this clinical need," said Prof. Wong Tien Yin, Director of SERI and Co-Director of SAILOR.
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