Eye on Pharma: FDA Gives Green Light to Aflibercept in Prefilled Syringe

Regeneron’s aflibercept (Eylea) has been approved by the FDA for a prefilled syringe (PFS) presentation. The 2-mg, single-dose, PFS will offer the greater ease of use less preparation than the vial presentation of the drug used to treat a range of eye disorders.

"With [8] 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 and diabetic eye diseases," said George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, in a statement. "This approval may help doctors more conveniently and efficiently deliver Eylea to appropriate patients."

The approval comes just 3 months after Regeneron also received approval for the drug to treat all stages of diabetic retinopathy. The regulatory decision made aflibercept the only anti-vascular endothelial growth factor (anti-VEGF) therapy approved for 2 dosing regimens in this indication: every 8 weeks or every 4 weeks.

Both approvals coincide with increased pressure on Regeneron to defend its market share for the blockbuster drug. One challenge could come from Novartis’ innovator biologic, RTH258, brolucizumab. This novel biologic is a humanized single-chain antibody fragment with enhanced tissue penetration and rapid clearance from systemic circulation, and the agent has been shown to be more effective in reducing disease activity and retinal fluid than aflibercept.

Aflibercept is also the target of multiple biosimilar development programs; Momenta and Mylan entered a phase 3 pivotal trial of a biosimilar aflibercept candidate in 2018, and Coherus BioSciences is also advancing an aflibercept candidate as well as a ranibizumab candidate, referencing another anti-VEGF agent, Lucentis. Xbrane Biopharma and Samsung Bioepis are also both working on biosimilars of ranibizumab.

Finally, another anti-VEGF agent, bevacizumab, is widely used off-label in treating eye disorders, and has 1 recently launched biosimilar available in the United States: Amgen’s Mvasi.