NORTH AMERICA AND EUROPE AGE-RELATED MACULAR DEGENERATION THERAPEUTICS MARKET ANALYSIS

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North America and Europe Age-Related Macular Degeneration Therapeutics Market: Key Developments

On October 22, 2021, F. Hoffmann-La Roche Ltd, a Switzerland-based multinational healthcare company, announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or “wet” age-related macular degeneration (nAMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Neovascular AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month. Susvimo, previously called Port Delivery System with ranibizumab, is the first and only U.S. FDA-approved treatment for nAMD that offers as few as two treatments per year.

On March 31, 2022, Novartis AG, a Switzerland-based global healthcare company, announced that the European Commission (EC) has approved Beovu (brolucizumab) 6 mg for the treatment of visual impairment due to diabetic macular edema (DME). Approval in DME represents the second indication for Beovu granted by the EC, which was first approved for the treatment of wet age-related macular degeneration. The EC decision applies to all 27 European Union (EU) member states as well as Iceland, Norway, and Liechtenstein. The EC approval was based on year one data from the Phase III, randomized, double-masked KESTREL and KITE* studies, which met its primary endpoint of non-inferiority in change in best-corrected visual acuity (BCVA) from baseline versus aflibercept at year one. In both trials, following the loading phase, over half of patients (55.1% in KESTREL and 50.3% in KITE) in the Beovu 6 mg arm remained on a 12-week dosing interval through year one. Aflibercept dosing was aligned to the approved EU label in year one of treatment

On May 13, 2020, Boehringer Ingelheim International GmbH, a Germany-based pharmaceutical company, and CDR-Life Inc., a Switzerland-based biotechnology company, announced they have entered into a collaboration and licensing agreement to research and develop antibody fragment-based therapeutics for geographic atrophy (GA). GA is a progressive, irreversible retinal disease that occurs in patients with age-related macular degeneration (AMD) for which there is no current treatment. Together, with Boehringer Ingelheim’s expertise in the therapeutic development of biologics and CDR-Life’s strong know-how in antibody engineering, the two companies will progress CDR-Life’s preclinical candidate, with the aim to preserve sight for patients with GA.

On January 27, 2022, Biogen, a U.S.-based global biotechnology company,  announced that they have entered into an agreement whereby Samsung Biologics, South Korea based biotechnology company will acquire Biogen’s equity stake in the Samsung Bioepis joint venture for an aggregate consideration of up to US$ $2.3 billion. Upon the acquisition of Biogen’s stake, the companies will continue with its exclusive agreements, including commercialization of its current portfolio. This includes marketed products BENEPALI (etanercept), a biosimilar referencing ENBREL, IMRALDITM (adalimumab), a biosimilar referencing Humira, and FLIXABI (infliximab), a biosimilar referencing Remicade. Additionally, Biogen will also retain commercial rights for BYOOVIZTM (ranibizumab-nuna), an approved biosimilar referencing LUCENTIS (ranibizumab), as well as an investigational biosimilar candidate in development, SB15 (aflibercept), a proposed biosimilar referencing EYLEA.