RO-6867461

Faricimab

Diabetic macular edema and wet age-related macular degeneration

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.

About faricimab

  1. Roche and Chugai Pharmaceutical
  2. Bispecific VEGF/Ang-2 mAb
  3. Intravitreal (IVT)-administered treatment of DME and wet AMD
  4. Also being studied to treat retinal vein occlusion (RVO)
  5. 15% of adults with T2DM have DME
  6. 3.6M people have wet AMD in the G7 markets

Why is it a drug to watch?

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.

  1. Faricimab has the potential to reach blockbuster status separately for DME and wet AMD.
  2. Faricimab has demonstrated non-inferiority to EYLEA® in trial data to date.
  3. Pending 2-year data from phase 3 trials may demonstrate superior efficacy to existing treatments:
    • DME: RHINE and YOSEMITE
    • AMD: TENAYA and LUCERNE
  4. Faricimab has a more convenient dosing schedule of 16 weeks (demonstrated to be effective for 52% of DME patients and 80% of wet AMD patients in clinical trials).

Review and approval status

DME and wet AMD:   

June 2021: 
Submitted to MHLW in Japan   

July 2021:

  • BLA submitted for priority review by the U.S. FDA
  • Submitted to the EMA

Expected launch: 

2022: United States, Europe and Japan

Patents estimated to expire beginning in 2034

How will faricimab impact the market for DME and wet AMD?

  1. Prevalences of both DME and wet AMD are expected to continue increasing, with aging population and rising rates of diabetes.
  2. Mainstays of treatment are IVT-injected VEGF inhibitors, with EYLEA and LUCENTIS as standard of care.
  3. Laser treatment is also an option.
  4. EYLEA’s dominance is expected to be challenged by the five agents currently approved or in active late-phase development:
    • Faricimab
    • KSI-301 (Kodiak Sciences)
    • RGX-314 (REGENXBIO Inc)
    • SUSVIMO™: ranibizumab port delivery system (Roche; twice yearly but ocular implantation)
    • OPT-302 (Opthea Limited)
  5. Novel MOA of faricimab might ultimately provide greater efficacy than VEGF inhibitors, although existing results show similar efficacy and safety.
  6. If so, faricimab is expected to reduce the overall market share of VEGF inhibitors by 67% in 2030.
  7. Uptake of faricimab might be higher than that of other new drugs because:

    • It will likely be used as early therapy
    • Switching from EYLEA or other treatments is possible given the less-frequent dosing
    • It is a potential candidate for patients with nonresponse to other treatments
    • It has the potential to increase the drug-treated population (from ~78% of wet AMD patients) due to less-frequent dosing.

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.

$1.31B
Expected sales in 2026
95%
probability of success for
faricimab in the United States
Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rates Prediction current as of December 15, 2021

Drug Timeline & Success Rates

– Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rate prediction current as of December 15, 2021

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