Extended-Interval Faricimab Versus Monthly Ranibizumab
JAMA Ophthalmology, September 2020
Faricimab, a bispecific antibody for intraocular use, has been proven as safe and effective as ranibizumab in neovascular age-related macular degeneration (AMD) when given every four or eight weeks. This led Khanani et al. to investigate whether the maintenance interval for faricimab could be extended up to 16 weeks without sacrificing vision gains obtained on average before extension. They found that vision and anatomic improvements were maintained through follow-up and appeared comparable to those achieved with monthly ranibizumab.
For this phase 2 trial, the researchers included 76 patients (mean age, 78.5 years) who had treatment-naive choroidal neovascularization related to AMD. The study participants’ best-corrected visual acuity (BCVA) ranged from a letter score of 73 (approximately 20/40) to 24 (approximately 20/320). Participants were assigned randomly (1:2:2) to receive intravitreal ranibizumab (0.5 mg) every four weeks or faricimab (6.0 mg) every 12 or 16 weeks following four consecutive injections of faricimab every four weeks. Rescue injections were not permitted.
Both faricimab groups received monthly treatment for the initial four months, after which the dosing intervals were extended in the faricimab groups. Patients in the 16-week group were checked for disease activity at week 24. Those without active disease continued on the same schedule through week 52, and those with disease activity had their dosing interval shortened to 12 weeks. Study medication was given up to week 48, and the final visit was at week 52. The main outcome measure was change in BCVA from baseline to week 40. Secondary endpoints included safety findings, monthly changes in BCVA, and anatomic changes from baseline to weeks 40 and 52.
At week 24, which was 12 weeks after the final loading-dose injection, 36 (65%) of the 55 faricimab recipients had no disease activity. At week 40, the adjusted mean gains in BCVA from base-line were 11.4 for the ranibizumab group, 9.3 for the 12-week faricimab group, and 12.5 for the 16-week faricimab group. The mean (standard deviation)total number of injections from baseline to week 52 was 12.9 (0.25), 6.7 (0.91), and 6.2 (0.93), respectively. Secondary BCVA and anatomic outcomes for faricimab resembled those for the primary end point and appeared comparable to findings for ranibizumab. No new safety concerns arose. (Also see related commentary by Irina De La Huerta, MD, PhD, Stephen J. Kim, MD, and Paul Sternberg Jr., MD, in the same issue.)
The original article can be found here.