Study Assesses Efficacy of Faricimab in Patients With Diabetic Macular Edema

Patients with diabetic macular edema (DME) receiving faricimab (FAR), a bispecific Ang-2/VEGF-A inhibitor, experienced similar vision gains in comparison to those receiving aflibercept (AFL), say investigators after 1 year of research. Results from this study were presented at the American Academy of Ophthalmology 2021 Annual Meeting, held in New Orleans from November 12-15.

Patients were enrolled in YOSEMITE (ClinicalTrials.gov Identifier: NCT03622580) and RHINE (ClinicalTrials.gov Identifier: NCT03622593), 2 randomized, double-masked, active comparator-controlled, 100-week trials consisting of 940 and 951 patients, respectively. Patients received either 6 mg of FAR every 8 weeks (FAR q8w), or 6 mg of FAR per protocol-driven personalized treatment interval (FAR PTI), or AFL (2 mg every 8 weeks). 

The average 1-year best corrected visual acuity gains with FAR q8w (10.7 and 11.8 letters in YOSEMITE and RHINE) or FAR PTI (11.6 and 10.8 letters) were comparable to AFL q8w (10.9 and 10.3 letters). In addition, FAR demonstrated more favorable anatomic outcomes (CST, fluid). The investigators noted that at week 52, more than 50% of patients in the FAR PTI arm were on q16w dosing and more than 70% were on equal or greater to q12w dosing. FAR was well tolerated by patients, with no vasculitis/occlusive retinitis reported. 

Overall, at 12 months, FAR q8w and FAR PTI were comparable to AFL q8w. The investigators concluded that in addition to this, they observed anatomic improvements with the FAR regimens and FAR had the potential for extended dosing. 

Reference

Ferrone PJ, Haskova Z, Silverman D. Efficacy and safety of faricimab in DME: one-year results from the phase 3 YOSEMITE and RHINE trials. Paper Presented at: American Academy of Ophthalmology 2021 Annual Meeting; November 12-15, 2021; New Orleans. Abstract PA043.