Regeneron Wins FDA Approval for Rare Immune
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August 24, 2023Aug. 18, 2023 - Regeneron Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Eylea HD (aflibercept) Injection 8mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). The recommended dose for Eylea HD is 8mg (0.07mL of 114.3mg/mL solution) every four weeks (monthly) for the first three months across all indications, followed by 8mg every 8 to 16 weeks (2 to 4 months) in wAMD and DME and every 8 to 12 weeks (2 to 3 months) for DR. Eylea is a long-acting injectable form of aflibercept that only needs to be given by a healthcare provider once every 2 to 4 months after an initial dosing period . It is used to treat the following conditions:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD) – a condition where new blood vessels grow under the retina where they leak blood and fluid.
- Macular Edema Following Retinal Vein Occlusion (RVO) – a swelling in the retina caused by a blockage in the blood vessels.
- Diabetic Macular Edema (DME) – a build-up of fluid in the retina that is caused by leaking blood vessels.
- Diabetic Retinopathy (DR) – an eye disorder in diabetics that can lead to a buildup of fluid in the retina and cause blindness.
- Retinopathy of Prematurity (ROP) – an eye condition in premature babies that affects the retina.