Treatment choices for patients with diabetic macular edema (DME) or wet age-related macular degeneration (AMD) include invasive, burdensome administration that limits treatment uptake. Faricimab offers a potentially more convenient option: it will be administered less frequently, on average, than standard of care. As the first bispecific antibody to launch in ophthalmology, it has the potential to be more efficacious than current standard of care, although data so far indicate it is non-inferiority.
Faricimab is the first dual VEGF/Ang-2 inhibitor to treat DME and wet AMD. Phase 3 trial results show similar visual outcomes and safety profile to existing treatments. However, its less-frequent dosing schedule will be attractive to clinicians and patients.
DME and wet AMD:
Submitted to MHLW in Japan
2022: United States, Europe and Japan
Patents estimated to expire beginning in 2034
How will faricimab impact the market for DME and wet AMD?
What gaps in treatment does faricimab fill?
The largest unmet need for patients with DME or wet AMD has been a therapy with at least the efficacy and safety profile of existing VEGF inhibitors but with less frequent IVT dosing. The chronicity and time requirement of clinic visits take a toll on patient and caregiver quality of life, particularly those of working age. Also important is a therapy superior to current VEGF inhibitors for improving visual acuity.
What hurdles might it need to overcome to reach blockbuster status?
The key consideration is entry into a market where the standard of care is providing the therapeutic response needed, with minimal side effects. Without clear demonstration of superior efficacy in clinical trials, adoption of faricimab might be challenged by an unwillingness to switch therapies. While the safety profile is currently consistent with existing therapies, side effects such as inflammation or vein occlusion occurring post-marketing could affect uptake.
“It seems to be a nice drug concerning efficacy and durability, so something like brolucizumab, but maybe a little bit better in durability. We are also waiting to see if safety is good. If it is and we can switch most or half of the patients to every 16 weeks dosing, it’s very nice for sure.”
– Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rate prediction current as of December 15, 2021