Genentech Announces Positive Two-Year Phase 3 Data for Vabysmo and Susvimo in Treating the Two Leading Causes of Adult Vision Loss

Recently, Genentech, a subsidiary of Roche, announced the latest two-year data from three Phase 3 clinical trials for two ophthalmology therapies, Vabysmo (faricimab-svoa) and Susvimo (ranibizumab injection). Susvimo was approved in October last year for the treatment of patients with wet age-related macular degeneration (AMD), marking the first FDA-approved wet AMD therapy that requires only two treatments per year. Vabysmo was approved in January this year for the treatment of AMD and diabetic macular edema (DME), making it the first bispecific antibody to gain FDA approval for treating these two ophthalmic conditions. Wet AMD and DME are two major causes of vision loss in adults.

These long-term results further support that these two therapies can treat patients with longer treatment intervals and fewer ocular injections while still achieving and maintaining vision improvements similar to the current standard of care.

Wet AMD is the leading cause of vision loss in people over 60. The current standard treatment involves injecting anti-vascular endothelial growth factor (VEGF) antibody drugs into the eye. However, responses vary among patients, with some requiring more than 10 injections per year to achieve significant efficacy. Susvimo implants a refillable port in the patient's eye, which is about the size of a grain of rice. It can continuously release the anti-VEGF antibody ranibizumab over several months, potentially reducing the treatment burden associated with frequent eye injections and enhancing the durability of efficacy. Ranibizumab is a vascular endothelial growth factor inhibitor that binds to and inhibits VEGF-A, a protein playing a key role in new blood vessel formation and vascular leakage.

▲Introduction to Susvimo (Image Source: Roche Official Website)

DME, Due to vascular damage and leakage occurring in the central area of the retina, causes macular edema, which is common in elderly diabetic patients and can lead to blindness. As a bispecific antibody, Vabysmo simultaneously targets and blocks two key pathogenic pathways—Angiopoietin-2 (Ang-2) and VEGF-A—both of which can destabilize blood vessels, causing them to leak and increasing inflammation. Targeting both pathways concurrently provides a complementary effect, further improving patients' vision.

▲Schematic diagram of Faricimab structure (Image source: Reference [2])

Results from two Phase III clinical trials show that at least 60% of patients eligible for extended Vabysmo dosing intervals can be treated every four months by the end of two years of treatment, with vision benefits meeting non-inferiority standards compared to the current standard of treatment every two months. This proportion is up from about 50% at the one-year treatment mark. Across both trials, nearly 80% of patients eligible for extended Vabysmo dosing intervals were able to extend their treatment interval beyond three months by the end of the second year.

Long-term results from another Phase 3 trial evaluating Susvimo showed that 95% of participants were able to maintain a 6-month dosing interval without additional treatment at the 2-year mark, achieving non-inferiority in vision improvement compared to monthly ranibizumab injections.

References:

[1] New Two-Year Data for Genentech’s Vabysmo and Susvimo Reinforce Potential to Maintain Vision With Fewer Treatments for People With Two Leading Causes of Vision Loss. Retrieved February 10, 2022, from https://www.gene.com/media/press-releases/14944/2022-02-10/new-two-year-data-for-genentechs-vabysmo

[2] Sharma et al., (2019). Faricimab: expanding horizon beyond VEGF. Eye, https://doi.org/10.1038/s41433-019-0670-1

(Original text has been abridged)

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