FDA accepts application for Roche?s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)
- Across four phase III studies, approximately half of patients receiving?faricimab?could extend treatment time to every four months ? the first time this level of durability has been achieved in phase III?nAMD?and DME studies
- If approved,?faricimab?would be the first and only medicine designed to target two distinct pathways that drive retinal diseases that can cause vision loss
- The European Medicines Agency has also validated the?faricimab?Marketing?Authorisation?Application submission in?nAMD?and DME
- Khan M, et al. Targeting Angiopoietin in retinal vascular diseases: A literature review and summary of clinical trials involving faricimab. Cells. 2020;9:1869.
- Heier JS, et al. The Angiopoietin/Tie pathway in retinal vascular diseases: a review. Retina-J Ret Vit Dis. 2021;41:1-19.
- Heier J. Faricimab Phase 3 Topline Results in Exudative AMD. Presented at: Angiogenesis, Exudation, and Degeneration 2021; 2021 Feb 13.
- Wykoff C. Faricimab Phase 3 Topline Results in Diabetic Macular Edema. Angiogenesis, Exudation, and Degeneration 2021; 2021 February 13.
- Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of faricimab (RO686746) in participants with neovascular age-related macular degeneration (AVONELLE-X) [Internet; cited July 2021]. Available from:?https://clinicaltrials.gov/ct2/show/NCT04777201.
- Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of faricimab (RO686746) in participants with diabetic macular edema (Rhone-X). [Internet; cited July 2021]. Available from:?https://clinicaltrials.gov/ct2/show/NCT04432831.
- 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 July 2021]. Available from:?https://clinicaltrials.gov/ct2/show/NCT04740931.
- 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; cited July 2021]. Available from:?https://clinicaltrials.gov/ct2/show/NCT04740905.
- Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures [Internet; cited July 2021]. Available from:?https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.
- Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.
- 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.
- 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.
- 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.
- Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35:556-64.
- National Eye Institute. Facts about diabetic eye disease [Internet; cited July 2021]. Available from:?https://nei.nih.gov/health/diabetic/retinopathy.
- American Optometric Association. Diabetic retinopathy [Internet; cited July 2021]. Available from:?https://www.aoa.org/healthy-eyes/eye-and-vision-conditions/diabetic-retinopathy.
- All About Vision. Macula Lutea [Internet; cited July 2021]. Available from:?https://www.allaboutvision.com/resources/macula.
- Liu E, et al. Diabetic macular oedema: clinical risk factors and emerging genetic influences. Clin Exp Optom. 2017;100:569-76.
- 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.
- Campochiaro P, et al. Primary analysis results of the phase 3 archway trial of the port delivery system with ranibizumab for patients with neovascular AMD. American Society of Retina Specialists Annual Meeting; 2020 Jul 24-26.
Dr. Nicolas Dunant Phone: +41 61 687 05 17 | Patrick Barth Phone: +41 61 688 44 86 |
Dr. Barbara von Schnurbein Phone: +41 61 687 89 67 | Karsten Kleine Phone: +41 61 682 28 31 |
Nina M?hlitz Phone: +41 79 327 54 74 | Nathalie Meetz Phone: +41 61 687 43 05 |
Roche Investor Relations | |
Dr. Karl Mahler Phone: +41 61 68-78503 e-mail:?karl.mahler@roche.com | Jon Kaspar Bayard Phone: +41 61 68-83894 e-mail:?jon_kaspar.bayard@roche.com |
Dr. Sabine Borngr?ber Phone: +41 61 68-88027 e-mail:?sabine.borngraeber@roche.com | Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail:?bruno.eschli@roche.com |
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail:?birgit.masjost@roche.com | Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail:?gerard.tobin@roche.com |
Investor Relations North America | |
Loren Kalm Phone: +1 650 225 3217 e-mail:?kalm.loren@gene.com |