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FDA approves Eylea injection prefilled syringe

21/08/2019By Myles Hume
US regulators have cleared a new and more convenient method to administer Regeneron Pharmaceuticals’ blockbuster macular disease drug, Eylea.

On 13 August, the US Food and Drug Administration (FDA) approved the Eylea prefilled syringe. The 2mg, single-dose therapy is expected to provide physicians with a new drug delivery method that requires fewer preparation steps than the use of vials.

The approval makes the injectable eye drug the only anti-VEGF approved to treat four retinal conditions with a single dose-strength prefilled syringe. Market supply of the product will become available to eyecare providers later this year.

George Yancopoulos
George Yancopoulos
"This approval may help doctors more conveniently and efficiently deliver Eylea to appropriate patients”
George Yancopoulos, Regeneron Pharmaceuticals

"With eight pivotal Phase 3 trials and millions of injections used around the world, Eylea sets a high bar for visual acuity and safety across multiple retinal diseases, including wet age-related macular degeneration (AMD) and diabetic eye diseases," Dr George Yancopoulos, president and chief scientific officer of Regeneron, said.

"This approval may help doctors more conveniently and efficiently deliver Eylea to appropriate patients."

It marks another significant milestone for the drug, after the FDA approved it for all stages of diabetic retinopathy in May. In the US, Eylea is also indicated for neovascular AMD, macular edema following retinal vein occlusion, and diabetic macular edema (DME).

Locally, Eylea is registered on the Australian Register of Therapeutic Goods and listed on the Pharmaceutical Benefits Scheme for the treatment of neovascular AMD, visual impairment due to macular oedema secondary to central retinal vein occlusion and DME.

A spokesperson for Bayer Australia, previously told Insight the company will continue to explore opportunities for additional indications.

In 2018, its seventh year on the market, Eylea’s net product sales were US$4.08 billion (AU$6.02 b) in the US and US$6.75 billion (AU$9.96 b) globally. It accounts for approximately 70% of the overall branded US anti-VEGF market for serious retinal disease.


More reading:

FDA grants Eylea approval to treat diabetic retinopathy
Eylea syringes linked to adverse patient reactions in the U.S
Eylea shown to reverse diabetic retinopathy in some cases
New Zealand subsidises Eylea for AMD and DMO

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