Faricimab maintained vision improvements with extended treatment intervals up to 4 months for people with retinal vein occlusion in phase III studies

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Roche revealed positive topline long-term results from the global phase III BALATON and COMINO studies, evaluating extended treatment intervals with faricimab (Vabysmo; Roche/Genentech) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO).^1,2

According to the company, from weeks 24 to 72, all people in both studies received faricimab using a treat-and-extend dosing regimen, which allows tailoring of their treatment interval according to the individual patient's response to treatment. Data showed that people treated with faricimab extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the studies.

Moreover, the company noted in its news release faricimab continued to show robust and sustained drying of retinal fluid from baseline up to week 72, as measured by reduction in central subfield thickness. This is the first time that vision and anatomical improvements have been maintained for more than a year using a personalized treat-and-extend dosing regimen in global phase III studies for both BRVO and CRVO. In both studies, Faricimb was generally well-tolerated and the safety profile was consistent with previous studies.

Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, pointed out the studies are the first to show vision maintenance and anatomical improvements up to 72 weeks in both central and branch RVO.

“These data further support Vabysmo’s potential as a new treatment for RVO, allowing people to preserve their vision while spending less time managing their condition,” Garraway said in the news release.

The company also noted RVO impacts 28 million people globally and, if approved, would be the third indication for the drug in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).^3-7 Together, the three conditions affect around 70 million people worldwide and are among the leading causes of vision loss.^3,8-11

Detailed results from weeks 24 to 72 of the phase III BALATON and COMINO studies will be presented at an upcoming medical meeting.

Data from the first 24 weeks of the phase III BALATON (NCT04740905) and COMINO (NCT04740931) studies, presented at Angiogenesis, Exudation and Degeneration 2023, demonstrated early and sustained vision improvement with faricimab, with both studies meeting their primary endpoints of non-inferior vision gains compared to aflibercept. A secondary endpoint showed that faricimab achieved rapid and robust drying of retinal fluid from baseline to week 24, as measured by reduction in central subfield thickness.¹²

Accordng to the news release, the BALATON study was conducted in 553 people with branch retinal vein occlusion. The COMINO study was conducted in 729 people with central retinal or hemiretinal vein occlusion. The primary endpoint of each study was the change in best-corrected visual acuity from baseline at 24 weeks. Secondary endpoints (weeks 0-24) included change in central subfield thickness and drying of retinal fluid, from baseline over time up to week 24. Secondary endpoints (weeks 24-72) were treatment durability at 68 weeks and continuation of weeks 0-24 endpoints.

The company noted in its release it has submitted data up to 24 weeks to global health authorities, including the FDA and European Medicines Agency. A decision from the FDA is expected later this year.

According to Roche, faricimab is designed to target and inhibit two signaling pathways, which are linked to a number of vision-threatening retinal conditions, by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) to restore vascular stability.^13,14 The level of Ang-2 is elevated in RVO and it is thought that increased Ang-2 expression drives disease progression.^11,15

The company noted that faricimab has been approved in more than 80 countries around the world for people living with nAMD and DME, including the United States, Japan, the United Kingdom and the European Union, with public reimbursement in over 25 markets and more than 1.5 million doses distributed globally.¹⁶

Earlier this year, Ophthalmology Times reported that treat-and-extend dosing with faricimab, as seen in the YOSEMITE/RHINE studies (NCT03622580/NCT03622593, respectively), achieved good visual gains and extended durability over 2 years in patients with diabetic macular oedema (DME) compared with aflibercept (Eylea, Regeneron Pharmaceuticals).

“The better ‘drying effect’ of faricimab (as seen during the matched dosing phase as well as over the 2-year analysis of retinal fluid, including the time to achieve a dry retina) provides rationale for the efficacy and extended durability with dosing interval, up to every 16 weeks, compared to aflibercept dosed every 8 weeks. Faricimab will enable us, as retina specialists, to lower the treatment burden for our patients,” according to Jennifer I. Lim, MD, who reported the findings at the Association for Research in Vision and Ophthalmology 2023 meeting.

References:

1. Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to branch retinal vein occlusion (BALATON) [Internet; cited October 2023]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740905.
   

2. Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to central retinal or hemiretinal vein occlusion (COMINO) [Internet; cited October 2023]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740931.
   

3. Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019;9:010427. Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019;9:010427.
   

4. U.S. Food and Drug Administration (FDA). Highlights of prescribing information, Vabysmo. 2022. [Internet; cited October 2023]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.
   

5. Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for neovascular age-related macular degeneration and diabetic macular edema [Internet; cited October 2023]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
   

6. MHRA approves faricimab through international work-sharing initiative [Internet; cited October 2023]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
   

7. European Medicines Agency. Summary of Product Characteristics, Vabysmo, 2022.
   

8. Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35:556–64.
   

9. Connolly E, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br J Ophthalmol. 2018;102:1691–95.
   

10. Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures [Internet; cited October 2023]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.
    

11. Joussen et al. Angiopoietin/Tie2 signalling and its role in retinal and choroidal vascular diseases: a review of preclinical data. Eye. 2021;35:1305-1316.
    

12. Tadayoni R, et al. Faricimab in RVO: Results from the BALATON and COMINO phase 3 studies. Presented at: Angiogenesis, Exudation and Degeneration 2023, 10-11 February 2023; Florida, United States.
    

13. Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. The Lancet. 2022; 399:729-740.
    

14. Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. The Lancet. 2022; 399:741-755.
    

15. Regula JT, et al. Targeting key angiogenic pathways with a bispecific CrossMab optimized for neovascular eye diseases. EMBO Molecular Medicine. 2016;8:1265–88.