(An active ingredient is what makes a drug work.) It comes as a liquid solution in a vial or prefilled syringe. Your doctor will inject Eylea directly into your eye. For more details on Eylea ...

Alongside the financial details on its first-quarter performance, Regeneron also revealed that the FDA last week rejected the company’s application for a prefilled syringe version of Eylea HD.

section. Eylea comes as a solution inside single-use vials and prefilled syringes. Your doctor will give Eylea to you as an intravitreal injection, which is an injection into your eye. Bring ...

REGN filed an application with the FDA for the use of the Eylea HD pre-filled syringe (PFS). A potential approval and launch are expected by mid 2025. Longer-term data in wet age-related macular ...

The European Medicines Agency (EMA) has approved the pre-filled syringe for the administration of Eylea 8 mg (114.3 mg/ml solution for injection) in the European Union. The new pre-filled syringe ...

The U.S. Food and Drug Administration declined to approve a pre-filled syringe version of Eylea HD last week citing issues with a third-party supplier. The FDA has committed to a speedy review of ...

Another complete response letter from the U.S. FDA for Regeneron Pharmaceuticals Inc.’s age-related macular degeneration (AMD) therapy Eylea (aflibercept) – along with disappointing sales of the VEGF ...

Moreover, in April 2025, Regeneron's US supplementary application for Eylea HD's prefilled syringe was rejected; this packaging format is important for the product's competitiveness with Vabysmo ...

with Eylea HD showing strong performance and new innovations like a pre-filled syringe on the horizon. Dupixent continues to drive growth, especially with the addition of COPD to its label ...

EYLEA HD is anticipated to gain traction with the launch of a prefilled syringe in mid-2025 and label expansions for macular edema and extended dosing intervals. Management believes these ...