Ophthalmology

Neovascular AMD and DME (Diabetic Macular Edema) are two of the leading causes of  vision loss worldwide. Around 20 million people are living with  nAMD (neovascular age-related macular degeneration), the leading cause of vision loss in people over the age of  60, and around 21 million people are living with DME, a leading  cause of vision loss in working-age adults. These conditions  will impact even more people around the world as the global population ages and the prevalence of diabetes increases.

Vision loss can impair daily activities, limit social interactions, and lead to increased dependency, depression, and anxiety disorders. The current standard of care for both conditions is injections that  inhibit VEGF (Vascular Endothelial Growth Factor), known as ‘anti-VEGF injections’. Whilst these treatments are effective, people living with nAMD and DME have  to visit their ophthalmologist as often as monthly for eye injections  to help maintain vision gains and/or prevent vision loss. This  high treatment burden can lead to under-treatment and,  potentially, less than optimal vision outcomes. Therefore, there is  a significant need for more effective and longer-lasting therapies  for people with these conditions.

As the first bispecific antibody approved for the eye, Vabysmo® offers a dual MoA in a single molecule to treat conditions like Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME) and Macular Edema providing fresh hope to patients with these vision-threatening illnesses. It represents a paradigm shift in the treatment of retinal conditions with its innovative MoA (Mode of Action) targeting two key pathways—Angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF-A). By simultaneously neutralizing these pathways, Vabysmo® aims to stabilize blood vessels in the retina, reducing inflammation, leakage, and abnormal vessel growth more effectively than previous treatments targeting VEGF alone. This sustained blood vessel  stabilization may improve disease control and vision outcomes for  longer.

Furthermore, Phase III studies in nAMD and DME have shown that treatment with Vabysmo® at intervals of up to four months improved vision and anatomical outcomes in the retina, with up to 33% fewer injections required over two years. With over 60% of individuals able to extend treatment intervals to every four months and nearly 80% to every three months or longer, Vabysmo® offers a less burdensome treatment schedule, potentially improving long-term vision outcomes.

References:

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• 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;102:1691–5.

• Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures. [Internet; cited 2018 October]. Available from:  https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.

• All About Vision. Macula lutea. [Internet; cited 2021 February]. Available from: https://www.allaboutvision.com/resources/macula/. 6. Park SJ, et al. Extent of exacerbation of chronic health conditions by visual impairment in terms of health-related quality of life. JAMA  Ophthalmol. 2015;133:1267–75.

• Taylor DJ, et al. How does age-related macular degeneration affect real-world visual ability and quality of life? A systematic review. BMJ Open. 2016;6:e011504 

• Heier, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD: week 48 results of TENAYA and  LUCERNE, two randomized, double-masked, phase 3, non-inferiority trials. The Lancet. 2022; https://doi.org/10.1016/S0140- 6736(22)00010-1.

• Wykoff 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; https://doi.org/10.1016/S0140- 6736(22)00010-1.

• FDA. Highlights of prescribing information, Vabysmo. 2022

• Liu E, et al. Diabetic macular oedema: clinical risk factors and emerging genetic influences. Clin Exp Optom. 2017;100:569–76. 12. Wong WL, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic  review and meta-analysis. Lancet Glob Health. 2014;2:106–16.

• ClinicalTrials.gov. A Study to Evaluate the Long-Term Safety and Tolerability of Vabysmo in Participants With Neovascular Age-Related  Macular Degeneration (AVONELLE-X) [Internet; cited January 2022]. Available from: https://clinicaltrials.gov/ct2/show/NCT04777201. 14. ClinicalTrials.gov. A Study to Evaluate the Long-Term Safety and Tolerability of Vabysmo in Participants With Diabetic Macular Edema (Rhone-X) [Internet; cited January 2022]. Available from: https://clinicaltrials.gov/ct2/show/NCT04432831.

• ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Vabysmo in Participants With Macular Edema Secondary to Central  Retinal or Hemiretinal Vein Occlusion (COMINO) [Internet; cited January 2022]. Available from:  https://clinicaltrials.gov/ct2/show/NCT04740931.

• ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Vabysmo in Participants With Macular Edema Secondary to Branch  Retinal Vein Occlusion (BALATON) [Internet; cited January 2022]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740905. 17. Song, P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk  factors. Journal of Global Health. 2019:9(1).