Wet AMD trials miss the mark while biosimilar battlelines form

Patient outcomes in neovascular (wet) age-related macular degeneration (nAMD) did not see improvement despite the addition of a multitargeted trap fusion protein developed by Melbourne-based biotech company Opthea to anti-VEGF therapy. Meanwhile, Bayer faces intensified competition from the biosimilar market.

Presented at the recent American Society of Retina Specialists meeting, results after a year of treatment with Ophthea’s sozinibercept showed that best corrected visual acuity (BCVA) improved by an average of 13.66 EDTRS letters with Eylea (aflibercept) alone, compared to 12.82 and 13.48 letters with Eylea plus two dosing schedules of sozinibercept.

Unblinded findings from a phase III trial comparing Novartis’ Lucentis (ranibizumab) with or without sozinibercept similarly revealed no significant enhancement in key outcomes with the endothelin antagonist.

Despite promising phase II data, where sozinibercept showed potential, phase III trials failed to replicate these results. Opthea CEO, Frederic Guerard, said “We are disappointed that COAST and ShORe did not demonstrate the improvements in vision with sozinibercept combination therapy compared to standard of care that we had hoped for. We are grateful to all patients, clinical investigators, and their staff worldwide who participated in the sozinibercept Phase 3 clinical program.”

Following the failure of COAST and ShORe trials to meet primary endpoints, Opthea has implemented significant headcount reductions, including an approximate 85% reduction in staff and a 50% reduction in the Board of Directors. The company is currently in trading suspension.

In a related development, Bayer and Regeneron have initiated legal proceedings against Sandoz in the Australian Federal Court, alleging infringement of Regeneron’s AU2012205599 patent. This patent pertains to methods of treating angiogenic eye disorders, including AMD, diabetic retinopathy, and retinopathy of prematurity (ROP). Regeneron seeks both an interlocutory injunction and permanent relief.

The initial case management hearing occurred on 25 June, during which Sandoz confirmed its intention to list and launch Afqlir, a biosimilar to Eylea, in Australia starting 1 December 2025. Sandoz has indicated it will not market its other ARTG-listed aflibercept biosimilar, Enzeevu, in Australia in 2025. Additionally, Sandoz plans to file a cross-claim seeking to invalidate the AU599 patent, citing lack of novelty. The hearing for Regeneron/Bayer’s interlocutory injunction application is scheduled for 14 August 2025.

Moreover, in March 2025, Celltrion’s Eydenzelt (CT-P42), a biosimilar to Eylea, received approval from the Therapeutic Goods Administration (TGA) for treating visual impairment due to myopic choroidal neovascularisation (myopic CNV). This approval marks the first aflibercept biosimilar registered in Australia.

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