This Phase 3 study recently confirmed the clinical equivalence of a proposed biosimilar aflibercept (SDZ-AFL) to reference aflibercept (Eylea) in treating neovascular age-related macular degeneration.

Ref-AFL “neutralizes all VEGF-A and B isoforms and placental growth factor”, the researchers note in their article published in Retina. It has been approved in the U.S. for treating nAMD since 2011. The 52-week study found that both SDZ-AFL and Ref-AFL showed comparable improvement in best-corrected visual acuity (BCVA) at Week 8 and maintained similar efficacy through Week 52.

The SDZ-AFL group demonstrated a mean gain of 6.8 letters, while the Ref-AFL group showed a 6.9 average letter gain. The safety profiles were equivalent, with similar rates of treatment-related adverse events and immunogenicity across both groups. The study also notes secondary endpoints at all timepoints remained comparable between SDZ-AFL and Ref-AFL.

“The long-term safety and efficacy of the proposed biosimilar after 1 year posttreatment are currently unconfirmed; however, given the demonstration of equivalence reported here, it would be expected that the long-term treatment response will be aligned to that of Ref-AFL,” the researchers write. SDZ-AFL and other biosimilars may offer opportunities to expand patient access to anti-VEGF treatment and improve their outcomes.

The randomized, double-masked, multicenter trial involved 485 neovascular age-related macular degeneration (nAMD) participants who received either SDZ-AFL or reference aflibercept (Ref-AFL). After the initial three monthly doses, participants were switched to maintenance dosing every 8 weeks, consistent with current clinical practice for nAMD treatment. The primary endpoint was the mean chance in BCVA from baseline to Week 8. Anatomical outcomes, BCVA at Weeks 24 and 52, safety, and pharmacokinetics were among the secondary endpoints.

A full list of author disclosures can be found in the published research.