US-based drugmaker Regeneron Pharmaceutical has received the US Food and Drug Administration (FDA) approval for Eylea HD (aflibercept) 8mg to treat certain ophthalmic disorders.
Eylea is a vascular endothelial growth factor (VEGF) inhibitor that works by blocking the growth of new blood vessels and passing of fluid through blood vessels in the eye.
The drug is indicated for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular oedema (DME) and diabetic retinopathy (DR).
Its FDA approval is supported by the positive results from two double-masked, active-controlled clinical trials, the PULSAR study in wAMD and PHOTON study in DME.
Both studies evaluated Eylea HD 8mg compared to Eylea 2mg, and met their primary endpoint, showing non-inferior and clinically equivalent vision gains.
The most common adverse reactions include cataract, conjunctival haemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, retinal haemorrhage.
Regeneron board co-chair, president and chief scientific officer and Eylea principal inventor George D Yancopoulos said: “More than 10 years ago, we fundamentally changed the way that certain serious retinal diseases were treated with the introduction of Eylea.
“With the approval of Eylea HD, we have elevated the high standard that Eylea set.
“Our continued commitment to retinal diseases resulted in an important scientific innovation, evolving the proven efficacy and safety of Eylea into a new treatment, Eylea HD.”
In a separate development, Regeneron has received the US FDA approval for Veopoz (pozelimab-bbfg) to treat Chaple disease in adults and children, aged one year and above.
Also known as CD55-deficient protein-losing enteropathy, Chaple is an ultra-rare serious hereditary immune disease, driven by an overactivation of the complement system.
Veopoz is a fully human monoclonal antibody and is designed to target complement factor C5, a protein involved in complement system activation.
The US-based biotechnology company created Veopoz, the first and only treatment indicated specifically for CHAPLE, using its unique VelocImmune technology.
National Institute of Allergy and Infectious Disease (NIAID), National Institutes of Health (NIH) clinical genomics program co-director, immune system section molecular development chief Michael Lenardo said: “Most patients with CHAPLE disease are children who face severely debilitating symptoms and often life-threatening complications that begin in infancy.
“As an investigator in this pivotal trial and one of the discoverers of this disease, I saw first-hand the transformational clinical improvement that pozelimab achieves in those suffering from CHAPLE.
“The approval of pozelimab is a milestone to celebrate, providing a new medicine that can help these long-suffering patients.”
