Top 5 Most-Read Ophthalmology Articles of 2025

The continued expansion of the biosimilar market into ophthalmology is helping to redefine treatment landscapes for serious retinal diseases like neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME).

The most-read ophthalmology biosimilar stories of 2025 included FDA approvals and real-world data.

News in 2025 highlighted major US regulatory milestones for aflibercept biosimilars, along with critical real-world data confirming safety across various uses of anti–vascular endothelial growth factor (VEGF) biosimilars. As global health systems prioritize cost-effective care, robust clinical evidence and postmarket surveillance are proving crucial for integrating these treatments into routine ophthalmic practice.

Here is a roundup of the top 5 most important recent biosimilar ophthalmology articles:

5. Bevacizumab Biosimilar Fills Gap for Retinal Disease With Encouraging Safety Data

Real-world data provided critical reassurance regarding the safety of using the oncology-approved biosimilar Mvasi (bevacizumab-awwb) off-label for treating sight-threatening retinal conditions in Australia. This practice emerged because the subsidized reference product, Avastin (reference bevacizumab), was discontinued from Australia’s Pharmaceutical Benefits Scheme (PBS) in 2021 due to commercial reasons, prompting clinicians to turn to Mvasi as a go-to anti-VEGF therapy in public hospitals.

A large retrospective review evaluated 6230 intravitreal Mvasi injections administered to 1682 eyes between May 2022 and May 2024. The study, conducted across South Australia’s public hospitals, found that Mvasi possessed a strong safety profile, with sight-threatening complications occurring in less than 0.1% of cases. Researchers reported only 3 cases of bacterial endophthalmitis (0.05%), 3 cases of uveitis (0.05%), and zero cases of retinal vasculitis.

Adverse event rates were consistent with those observed with reference bevacizumab and other anti-VEGF agents, supporting Mvasi as a viable alternative for retinal care in Australia. The findings are timely, as this type of real-world data is essential for building clinician and regulatory confidence for off-label biosimilar use in therapeutic areas like ophthalmology.

Read the full article here.

4. Real-World Data Confirm Safety of Switching Between Ranibizumab Biosimilars

Early real-world data coming out of India confirm that switching between ranibizumab biosimilars is both safe and effective for patients undergoing treatment for retinal conditions. The interventional retrospective uncontrolled multicenter study was one of the first to provide insight into the effects of biosimilar-to-biosimilar switching among products administered intravitreally.

Data were collected from 7 eye care centers on patients previously treated with a ranibizumab biosimilar who then received at least 1 intravitreal injection of the ranibizumab biosimilar Ranieyes (0.5 mg). The primary indications treated included DME and macular neovascularization (MNV). During the study, 474 Ranieyes injections were administered to 268 eyes.

The results demonstrated that visual acuity and central subfield thickness (CST) significantly improved for the overall cohort and within patients with DME, MNV, and retinal vein occlusion (RVO). Crucially, the safety assessment found no reported drug-related ocular or systemic adverse events—including inflammation, vision loss, or vasculitis—across the study sites. This evidence supports the real-world safety of switching ranibizumab biosimilars without concerns over immunogenicity issues or significant adverse events.

Read the full article here.

3. FDA Approves Celltrion Aflibercept Biosimilar: Eydenzelt

The FDA granted approval to Celltrion’s aflibercept biosimilar, Eydenzelt (aflibercept-boav), which references Eylea (aflibercept). Eydenzelt is approved for the treatment of major retinal diseases, including wet AMD, macular edema following RVO, DME, and diabetic retinopathy. This approval marks Celltrion’s first FDA-approved biologic product in ophthalmology.

The FDA based its decision on a totality of evidence, including analytical, nonclinical, and clinical data. In a randomized, double-masked, multicenter phase 3 study involving 348 patients with DME, Eydenzelt was compared with Eylea. The study confirmed that Eydenzelt met the predefined equivalence criteria for the primary end point (change in best corrected visual acuity from baseline to week 8). The efficacy, safety, and immunogenicity secondary end points were also consistent with those observed for the reference product, Eylea.

This biosimilar was the sixth aflibercept biosimilar product to be approved in the US.

Read the full article here.

2. Study Confirms CT-P42 Therapeutic Equivalence to Reference Aflibercept in DME

In a phase 3 clinical trial, biosimilar candidate CT-P42 (Celltrion) was proven to be therapeutically equivalent to reference aflibercept (Eylea) for improving best-corrected visual acuity (BCVA) in adults with DME. The randomized, active-controlled, double-masked study assessed the biosimilar's efficacy, safety, pharmacokinetics (PKs), and immunogenicity. Therapeutic equivalence was achieved for the primary end point, which measured the change in BCVA from baseline to week 8.

Overall, both the CT-P42 group and the reference aflibercept group showed comparable improvements in BCVA through week 24. The safety profiles of the two products were also comparable, with similar proportions of patients experiencing treatment-emergent adverse events. The study, which included 348 patients with DME, also found that mean CST values were comparable at all post-treatment visits.

While the 24-week interim results strongly support equivalence and similar safety, authors noted that future studies should focus on gathering evidence to further investigate the long-term efficacy and safety of CT-P42 in routine clinical practice. CT-P42 has already received approval in the Republic of Korea and is currently under review by the FDA and the European Medicines Agency.

Read the full article here.

1. FDA Approves Pavblu for Retinal Conditions

Amgen’s Pavblu (aflibercept-ayyh) received FDA approval, making it the fifth biosimilar referencing Eylea (aflibercept) authorized for US patients with retinal diseases. Pavblu is approved to treat several retinal conditions, including neovascular age-related macular degeneration (wet AMD), diabetic macular edema, and diabetic retinopathy. The approval was based on data from a randomized, double-masked, phase 3 study comparing Pavblu (ABP 938) with Eylea in patients with wet AMD.

The study randomized 566 patients and involved a primary endpoint evaluation at week 8 that measured the change in best corrected visual acuity. The study demonstrated the biosimilarity of ABP 938 to the reference agent, finding no clinically meaningful differences between the 2 products.

Despite the regulatory success, Amgen and Regeneron, the maker of Eylea, are currently engaged in Biologics Price Competition and Innovation Act litigation regarding Pavblu. Regeneron alleges that Amgen infringed 32 patents covering the manufacturing and use of Eylea, and a court decision is pending on whether Amgen will be blocked from launching Pavblu at-risk.

Read the full article here.