The Top 5 Most-Read Ophthalmology Articles of 2024

The 2024 advancements in ophthalmology biosimilars marked a transformative phase for aflibercept alternatives, with multiple FDA approvals signaling expanded treatment options for retinal conditions. Interchangeability designations and robust clinical data emphasized the potential for improved access, cost savings, and healthcare innovation. However, ongoing patent disputes underscore the complexities of bringing these promising therapies to market.

Here are the top 5 ophthalmology biosimilar articles for 2024.

5. SB15 Effective, Safe in Treating nAMD Before, After Switching

A multiregion phase 3 study demonstrated that SB15, a biosimilar to Eylea (aflibercept), showed comparable efficacy, safety, immunogenicity, and pharmacokinetics in treating neovascular age-related macular degeneration (nAMD), both as a first-line therapy and after switching from the originator. Across 56 weeks, changes in visual acuity, retinal thickness, and choroidal neovascularization were minimal, with treatment-emergent adverse events being mild or moderate and similar across groups. The findings support the safety and effectiveness of switching patients from reference aflibercept to SB15.

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4. FDA Approves Biosimilar Enzeevu for Eye Conditions

Sandoz's Enzeevu (aflibercept-abzv) has become the fourth FDA-approved biosimilar referencing Eylea and includes interchangeability, enabling substitution at the pharmacy level without provider consent. Approved for treating nAMD, Enzeevu demonstrated comparable efficacy, safety, and pharmacokinetics to the reference product in a phase 3 study, with no significant differences in vision improvement or adverse events. This approval represents greater hope for more cost-effective options for managing nAMD, a leading cause of vision impairment.

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3. Ahzantive Receives FDA Approval as New Eylea Biosimilar

Formycon and its licensing partner Klinge Biopharma secured FDA approval for Ahzantive (aflibercept-mrbb), marking it as the third biosimilar referencing Eylea to receive approval. This milestone builds on prior approvals for Biocon Biologics' Yesafili and Samsung Bioepis' Opuviz earlier in 2024. The approval was based on robust data from the MAGELLAN-AMD phase 3 study, which demonstrated that Ahzantive's safety, efficacy, and tolerability were comparable to Eylea, with no new safety signals identified.

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2. FDA Approves Pavblu for Retinal Conditions

The FDA has approved Pavblu (aflibercept-ayyh), developed by Amgen, as the fifth biosimilar referencing Eylea to treat retinal conditions like nAMD and diabetic retinopathy. Clinical trials demonstrated Pavblu’s comparable safety and efficacy to Eylea, reinforcing its biosimilarity. Meanwhile, Amgen faces a legal challenge from Regeneron over patent infringement related to Pavblu’s development, with a court decision pending.

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1. FDA Approves First Eylea Biosimilars

The FDA has approved the first 2 biosimilars referencing Eylea: Yesafili (Biocon Biologics) and Opuviz (Samsung Bioepis), both VEGF inhibitors for treating conditions like nAMD and diabetic retinopathy. These biosimilars received interchangeability designations, too, enabling pharmacy-level substitution without physician approval, improving patient access and addressing drug shortages. However, their market entry may face delays due to ongoing patent litigation with Eylea’s maker, Regeneron.

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