The U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior- Approval Supplement (PAS) for Regeneron’s aflibercept injection (Eylea) prefilled syringe.
A 2 mg, single-dose, sterilised prefilled syringe provides specialists with a new way to administer Eylea that requires fewer preparation steps compared to vials.
Sydney ophthalmologist Dr Simon Chen said the approval is welcome news for retinal specialists and their patients.
“I currently treat many patients with conditions including exudative age related macular degeneration, polypoidal choroidal vasculopathy, diabetic macula oedema and retinal vein occlusions with regular intravitreal injections of Anti-VEGF agents including Eylea,” said Dr Chen.
“Currently, Eylea is packaged in a glass vial and the drug needs to be drawn up using a needle and transferred into a plastic syringe prior to injecting it into a patient’s eye. There are numerous benefits of using a pre-filled syringe, which include improved clinical efficiency as the process of preparing the drug for injection is streamlined i.e. the doctor needs to perform fewer steps which saves time for both the patient and the doctor.”
Dr Chen said by eliminating the need to transfer Eylea from a glass vial to a plastic syringe, the number of points at which mistakes can happen is reduced.
“There is less risk of inadvertent contamination of the drug, which in turn may reduce the risk of blinding endophthalmitis.”
Additionally, he said the use of a pre-filled syringe would be better for the environment as there is less wasted packaging, less plastic and less metal used for each injection.
The sterilised prefilled syringe offers the same medicine as the currently available Eylea, in an easier to use and administer presentation.
