FDA Extends Target Date for Eylea

The US Food and Drug Administration, usually referred to by the acronym FDA, has extended the target date for the drug’s approval by three months. A decision had been expected in August, but the FDA has announced that a final decision will be delayed until November 18 while the agency evaluates and categorises company responses to agency questions.

 

Eylea is the proposed brand name for VEGF Trap-Eye, a drug being prepared for global distribution by Regeneron and Bayer HealthCare. Regeneron will maintain exclusive distribution rights in the US, and Bayer Healthcare will handle sales for all regions outside of the US. In June, independent advisers to the FDA voted unanimously to back Eylea as an approved treatment for wet age-related macular degeneration.

Age-related macular degeneration, also known as AMD, is a painless, progressive degeneration of the centre of the retina. This area of the retina, known as the macula, is responsible for a critical area of the visual field and provides vision necessary for driving a car, reading, and recognising facial features. The illness does not cause complete blindness, but it significantly impacts the quality of life for those affected.

Approximately 10 percent of patients diagnosed with AMD have a form of the illness known as wet AMD. This form of AMD is caused by the development of abnormal blood vessels under the macula in a process called neovascularisation. The abnormal blood vessels exude blood, and the leakage causes irreversible scarring that destroys the rods and cones of the macula.

Laser intervention can be used to seal off the abnormal blood vessels, but the damage that has already occurred cannot be reversed by laser treatment. In fact, the laser does an unavoidable amount of additional damage to the retina as the blood vessels are sealed.

In a different treatment option, anti-vascular endothelial growth factor chemicals, called anti-VEGF agents, are injected directly into the eye. These chemicals shrink the abnormal blood vessels and, in 45 percent of clinical cases, dramatically improve impaired vision.

Vascular endothelial growth factor-A and placental growth factor are two proteins involved in the growth of abnormal blood vessels. VEGF Trap is specifically designed to bind these proteins and prevent neovascularisation, and VEGF Trap-Eye is a form of VEGF Trap formulated for injection directly into the eye.

Leading anti-VEGF agents that are currently available require monthly injections. Eylea injections would be required only every other month. The reduced injection frequency would improve patient quality of life, reduce the incidence of complications related to injections into the eye, and open medical practitioners’ schedules to see and treat additional patients.

Les writes about laser eye surgery for Personal Eyes where you can find out more about eye procedures to suit your lifestyle.

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