Two-Year Data on Faricimab, Ranibizumab Implant Highlight Treatment Durability

Data show ≥60% of eligible faricimab patients with DME could extend treatment to every 4 months, while 95% of ranibizumab implants in wetAMD treatment maintained a six-month schedule.

New two-year, phase 3 data on faricimab (Vabysmo) for the treatment of diabetic macular degeneration (DME) and ranibizumab injection (Susvimo) 100 mg/ml for intravitreal use via ocular implant for the treatment of wet age-related macular degeneration (AMD) showcased the potential for improved duration between treatments and fewer eye injections for patients.

The findings on treatments for the 2 leading causes of vision loss was presented at Angiogenesis, Exudation and Degeneration 2022, obtained from the faricimab YOSEMITE and RHINE studies and the ranibizumab Archway study.

In YOSEMITE and RHINE, data show ≥60% of those eligible for extended dosing with faricimab could be treated every 4 months at the 2 year mark, for a 10 percentage point increase from the primary analysis at 1 year. Additionally, nearly 80% of patients eligible for extended dosing could be treated every 3 months or longer.

Then, in ARCHWAY, ranibizumab showed 95% of patients went 6 months between treatment at 2 years, considered the fourth completed refill-change interval, and maintained vision outcomes noninferior to monthly injections.

In a statement, Levi Garraway, MD, PhD, chief medical officer, Genentech, noted that the first-of-their-kind treatments in retina are “the culmination of over a decade of pioneering research.”

“Results from these three studies reinforce the potential of Vabysmo and Susvimo to redefine standards of care and reduce treatment burden for people living with diabetic macular edema and wet AMD,” Garraway said.

YOSEMITE and RHINE Two-Year Results

YOSEMITE and RHINE are randomized, multi-center phase 3 studies evaluating the efficacy and safety of faricimab compared to aflibercept in 1,891 patients with DME.

In the dual studies, patients with DME received faricimab, given either every 2 months or up to every 4 months utilizing a treat-and-extend approach, or aflibercept given every 2 months. The two-year results of faricimab show patients maintained vision improvements achieved in the first years and the gains were continuous non-inferior to those achieved by aflibercept patients.

YOSEMITE found the average vision gains from baseline at 2 years was +10.7 eye chart letters in both treat-and-extend and 2-month arms and +1-.9 letters in the aflibercept arm of the study. RHINE observed the average vision gains from baseline at 2 years were +10.1 letters in treat-and-extend and +10.9 in the 2-month arms, compared to +9.4 letters in the aflibercept arm.

Data show 60% (n = 162 of 270) of faricimab treat-and-extend patients in YOSEMITE and 64.5% (n = 185 of 287) in RHINE achieved 4-month dosing at 2 years. This was considered an increase over the one-year results, which showed 52.8% (n = 151 of 286) of faricimab treat-and-extend patients in YOSEMITE and 51% (n = 157 of 308) in RHINE achieved four-month dosing.

Further data show an additional 18.1% (n = 49 of 270) of faricimab treat-and-extend patients in YOSEMITE and 13.6% (n = 39 of 287) in RHINE achieved 3-month dosing. Altogether, nearly 80% of faricimab treat-and-extended patients were able to go ≥3 months between treatments at the end of the second year.

Other results show consistent two-step or better improvement in diabetic retinopathy according to the Early Treatment Diabetic Retinopathy Study - Diabetic Retinopathy Severity Score (ETDRS-DRSS). At 2-years, 42.8% of faricimab treat-and-extend patients in YOSEMITE and 44.3% in RHINE achieved a two-step or better improvement from baseline.

Archway Two-Year Results

The Archway trial was a randomized, multicenter phase 3 study evaluating the efficacy and safety of ranibizumab injection 100 mg/L for intravitreal use via ocular implant, refilled every 6 months, compared to monthly intravitreal injections of ranbiziuab 0.5 mg in 415 patients.

Two-year results from the study showed vision was maintained by ranibizumab via ocular implant patients and was non-inferior to results achieved with monthly ranibizumab injections. Data show ranibizumab via ocular implant averaged -1.1 eye chart letters in visual acuity from baseline at 2 years, compared to an average of -0.5 letters from baseline with monthly ranibizumab.

Additionally, data show 95% of ranibizumab via ocular implant patients were able to go 6 months without requiring additional treatment in the second, third, and fourth refill-exchange intervals. The treatment was generally well-tolerated, with the most common adverse event of special interest (≥5%) as cataract, conjunctival bleb and vitreous hemorrhage.

More data on the safety and efficacy of ranibizumab will be presented from the phase 3 Portal study at the conference.