The following article is a part of conference coverage from the American Academy of Ophthalmology 2020, being held virtually from November 13 to 15, 2020. The team at Ophthalmology Advisor will be reporting on the latest news and research conducted by leading experts in ophthalmology. Check back for more from the AAO 2020.
A review of phase 2 and preclinical data supports the improved and sustained efficacy of faricimab for diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD), according to researchers who presented their findings during a poster presentation at the American Academy of Ophthalmology 2020 meeting.1
Faricimab, a novel bispecific antibody, targets angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).1,2 The research shows dual Ang-2/VEGF-A inhibition in murine models that “synergistically reduced inflammation, leakage, and neovascularization.”1
The investigators gathered their preclinical in vivo and phase 2 clinical data from the BOULEVARD study (NCT02699450) and the STAIRWAY study (NCT03038880).
They pointed to the results of the BOULEVARD study, in which faricimab 6.0 mg administered to treatment-naïve subjects led to “statistically significant” best-corrected visual acuity (BCVA) gain, longer median time to disease reactivation in off-treatment periods, and greater regression of diabetic retinopathy (DR) compared with monthly ranibizumab.1 The team also noted that in the STAIRWAY trial, BCVA and macular anatomy improvements with faricimab dosed every 16 and 12 weeks were comparable to those with monthly ranibizumab.1
A previous publication also shows that the phase 2 BOULEVARD trial compared the safety and efficacy of faricimab with ranibizumab in subjects with DME. Thatresearchers found that faricimab demonstrated “statistically superior visual acuity gains” vs ranibizumab at week 24 in treatment-naïve patients.2 Central subfield thickness reduction, diabetic retinopathy severity scale (DRSS) score improvement, and extended durability outcomes were reported.2 Investigators said that their findings suggest that patients with DME can benefit from the simultaneous inhibition of Ang-2 and VEGF-A offered with faricimab.2
In the STAIRWAY trial, researchers sought to determine how extended dosing with faricimab compares with monthly ranibizumab in treating patients with nAMD. At week 52 of that trial, faricimab dosing every 16 weeks and every 12 weeks resulted in the maintenance of initial vision and anatomic improvements comparable with monthly ranibizumab.3 Researchers conducting this study concluded that faricimab simultaneously neutralized Ang-2 and VEGF-A.3
The efficacy of faricimab is primarily due to its dual Ang-2/VEGF-A inhibition, according to the presenters. A likely secondary mechanism is the vascular stabilization effects of simultaneous Ang-2/VEGF-A neutralization, they explained.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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1. Eichenbaum DA, Lin H, Silverman D, et al.Faricimab: evidence for differentiation with dual angiopoietin-2 (ang-2)/VEGF-A inhibition in DME and nAMD. Presented at: American Academy of Ophthalmology 2020 Annual Meeting; November 13-15, 2020. Abstract PO388
2 Sahni J, Patel SS, Dugel PU. Simultaneous inhibition of angiopoietin-2 and vascular endothelial growth factor-a with faricimab in diabetic macular edema. Ophthalmol. 2019;126(8):1155-1170. doi: 10.1016/j.ophtha.2019.03.023.
3 Khanani AM, Patel SS, Ferrone PJ, et al. Efficacy of every four monthly and quarterly dosing of faricimab vs ranibizumab in neovascular age-related macular degeneration: the STAIRWAY phase 2 randomized clinical trial. JAMA Ophthalmol. 2020;138(9):964–972. doi: 10.1001/jamaophthalmol.2020.2699.