Biosimilars to shake up macular degeneration market, while emerging combo therapy on the horizon

Pharma News: Sandoz has unveiled the outcomes of its MYLIGHT Phase III trial in neovascular age-related macular degeneration (nAMD) for its biosimilar to Bayer’s Eylea (aflibercept). Commonly known as wet AMD, the disease affects an estimated 128,000 to 192,000 individuals across Australia.

Sandoz, soon to be spun-off from Novartis, reported that the study achieved the primary efficacy benchmark, demonstrating no clinically meaningful differences to Eylea – a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth.

The MYLIGHT trial was initiated in 2021, encompassing global sites including six in Australia, and will be paving the way for regulatory applications, with submissions anticipated within the upcoming months.

Commending this milestone achievement, Claire D’Abreu-Hayling, Chief Scientific Officer at Sandoz, said “This important milestone, confirming therapeutic equivalence of the biosimilar aflibercept with the reference biologic, takes us one step closer to providing patients with a key treatment in an area of high unmet need within ophthalmology. It also underscores our ability to provide high-quality, affordable biologics to individuals to help the treatment of their disease, and highlights the rich Sandoz pipeline of biologics.”

This adds to the earlier news from Samsung Bioepis and Biogen announcing the 1-year outcomes of the Phase 3 study for SB15, a proposed biosimilar to Eylea, were presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in April.

However, real-world evidence underscores the current issue of nAMD patients receiving fewer anti-VEGF eye injections than the optimal count of around seven, resulting in suboptimal visual outcomes compared to those receiving fixed, frequent therapy in randomised controlled trials. To this end, the advent of longer-acting therapies is poised to mitigate the treatment burden that often contributes to patient attrition, as well as addressing complications such as macular scarring or fibrosis.

Roche’s Vabysmo (faricimab) is the first bispecific antibody that gained TGA approval in August 2022 and has been reimbursed from January 2023 for nAMD and diabetic macular oedema (DMO). This treatment works by targeting and blocking the activity of angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF) proteins. Vabysmo is administered by four initial 4-weekly eye injections, followed by the potential of extending the injection interval up to every four months, as determined by the treating ophthalmologist.

Additionally, Australian start-up Opthea, under the leadership of CEO Megan Baldwin, has been developing OPT-302 (sozinibercept). Dr Dante Pierramici’s presentation at the 2023 American Society of Retina Specialists (ASRS) annual meeting revealed the company’s Phase 3 trial progress, enlisting patients globally to explore the combined efficacy of OPT-302 with Eylea and Novartis’ Lucentis (ranibizumab). The goal is to provide patients with improved visual acuity outcomes with combination therapy, presenting an encouraging prospect for further advancements in macular degeneration treatment.

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