MACULOPATIE: Vabysmo (Faricimab)

Date
Mar, 20, 2023

VABYSMO è un trattamento approvato dalla FDA e della EMA, utilizzato in caso di degenerazione maculare legata all’età essudativa e di edema maculare diabetico, progettato per bloccare sia il VEGF che l’Ang-2 nell’AMD umida e nel DME.

Viene iniettato direttamente nell’occhio.

 

Al momento attuale non è rimborsabile dall’ Asl.

ATTENZIONE

Le iniezioni come quella per VABYSMO possono causare:

  • infezione oculare (endoftalmite)
  • distacco di retina
  • aumento temporaneo della pressione oculare 

Sebbene non comuni, i pazienti sottoposti a iniezione di VABYSMO hanno avuto problemi gravi, talvolta fatali, correlati a coaguli di sangue, come infarti o ictus (eventi tromboembolici). Tali eventi sono molto rari.

 

 

 

BIBLIOGRAFIA

[1] Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures. [Internet; citazione di settembre 2022]. Consultabile all’indirizzo: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.

[2] 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.

[3] Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35:556-64.

[4] Heier JS, et al. The Angiopoietin/Tie pathway in retinal vascular diseases: a review. Retina-J Ret Vit Dis. 2021;41:1-19.

[5] EMA. Highlights of prescribing information, Vabysmo. 2022.

[6] Wells JA, et al.  Faricimab in Diabetic Macular Edema: Two-Year Results From the Phase 3 YOSEMITE and RHINE Trials. Presentato in occasione di Angiogenesis, Exudation and Degeneration 2022; 12 febbraio 2022.

[7] Heier, 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; https://doi.org/10.1016/S0140-6736(22)00010-1.

[8] 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)00018-6.

[9] Khanani A, et al. Faricimab in Neovascular Age-Related Macular Degeneration: Year 2 Efficacy, Safety, and Durability Results From the Phase 3 TENAYA and LUCERNE Trials. Presentato in occasione del congresso scientifico annuale dell’American Society of Retina Specialists del 2022; 14 luglio 2022.

[10] FDA. Highlights of prescribing information, Vabysmo. 2022.

[11] MHRA approves faricimab through international work-sharing initiative. [Internet; citazione di settembre 2022]. Consultabile all’indirizzo: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.

[12] Chugai Obtains Regulatory Approval for Vabysmo, the First Bispecific Antibody in Ophthalmology, for Neovascular Age-related Macular Degeneration and Diabetic Macular Edema. [Internet; citazione di settembre 2022]. Consultabile all’indirizzo: https://www.chugai-pharm.co.jp/news/cont_file_dl.php?f=220328eVabysmo_DME_nAMD_approval.pdf&src=[%0],[%1]&rep=130,909

[13] Dati in archivio di Roche.

[14] Clinical Trials.gov. A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (AVONELLE-X). [Internet; citazione di settembre 2022]. Consultabile all’indirizzo: https://clinicaltrials.gov/ct2/show/NCT04777201.

[15] Clinical Trials.gov. A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema (Rhone-X). [Internet; citazione di settembre 2022]. Consultabile all’indirizzo: https://clinicaltrials.gov/ct2/show/NCT04432831.

[16] 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; citazione di settembre 2022]. Consultabile all’indirizzo: https://clinicaltrials.gov/ct2/show/NCT04740931.

[17] Clinical Trials.gov A study to evaluate the efficacy and safety of faricimab (RO6867461) in participants with macular edema secondary to branch retinal vein occlusion (BALATON). [Internet; citazione di settembre 2022]. Consultabile all’indirizzo: https://clinicaltrials.gov/ct2/show/NCT04740905.

[18] Clinical Trials.gov. A study to investigate faricimab treatment response in treatment-naïve, underrepresented patients with diabetic macular edema (ELEVATUM). [Internet; citazione di settembre 2022]. Consultabile all’indirizzo: https://clinicaltrials.gov/ct2/show/NCT05224102.

[19] All About Vision. Macula Lutea. [Internet; citazione di settembre 2022]. Consultabile all’indirizzo: https://www.allaboutvision.com/resources/macula.

[20] Pennington KL, et al. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.

[21] Little K, et al. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration-the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.

[22] 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.

[23] 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.

[24] National Eye Institute. Facts about diabetic eye disease [Internet; citazione di settembre 2022]. Consultabile all’indirizzo: https://nei.nih.gov/health/diabetic/retinopathy.

[25] Liu E, et al. Diabetic macular oedema: clinical risk factors and emerging genetic influences. Clin Exp Optom. 2017;100:569-76.

[26] FDA. Highlights of prescribing information, Susvimo. 2021.

[27] FDA. Highlights of prescribing information, Lucentis. 2006.

27 Marzo 2023

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