Faricimab Found to Improve Vision for Patients with Retinal Vein Occlusion

Retinal vein occlusion is the second most common cause of vision loss from retinal vascular diseases.

A pair of global phase 3 studies showed positive results for faricimab (Vabysmo, Roche) in the treatment of macular edema due to branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).

Retinal vein occlusion (RVO) is the second most common cause of vision loss from retinal vascular diseases. In patients with RVO, the level of angiopoietin-2 (Ang-2) is increased, which can cause disease progression. RVO typically leads to sudden and painless vision loss from vein blockage that inhibits normal blood flow in the affected retina, which can cause ischemia, bleeding, fluid leakage, and macular edema. Macular edema is currently treated with repeated intravitreal injections of anti-vascular endothelial growth factor therapies.

Faricimab, the first and only bispecific antibody for the eye, inhibits 2 disease pathways associated with multiple retinal conditions that threaten vision. The drug works by neutralizing Ang-2 and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels, leading to the formation of new leaky blood vessels and increasing inflammation.

The 2 randomized, multicenter, phase 3 studies, BALATON and COMINO, analyzed the efficacy and safety of faricimab vs aflibercept. For the first 20 weeks, patients were randomized 1:1 to receive 6 monthly injections of faricimab (6 mg) or aflibercept (2 mg). Then, from weeks 24-72, all patients were administered faricimab (6 mg) up to every 4 months using a treat-and-extend approach.

In BALATON, 553 patients with BRVO were included, whereas the COMINO study enrolled 729 patients with CRVO or hemiretinal vein occlusion.

Both trials achieved their primary endpoints. Patients with macular edema due to BRVO and CRVO received faricimab injections every 4 weeks for up to 24 weeks, which showed non-inferior visual acuity gains compared to those receiving aflibercept injections every 4 weeks.

“These encouraging data demonstrate that Vabysmo could potentially provide a new treatment option for people living with retinal vein occlusion, a serious retinal vascular condition that can lead to irreversible vision impairment or vision loss,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, in a press release. “[The] results add to the extensive evidence supporting Vabysmo’s efficacy in treating multiple types of retinal conditions. We look forward to submitting these data to regulatory authorities.”

Further, the trials also showed that faricimab was associated with the rapid drying of retinal fluid from baseline through week 24, which was measured by reduction in central subfield thickness.

Faricimab was well-tolerated in both studies, with the safety profile found consistent with previous trials.

REFERENCE

Positive topline phase III results show Roche's Vabysmo improved vision for people living with retinal vein occlusion (RVO). Roche. October 27, 2022. Accessed October 27, 2022. https://www.roche.com/media/releases/med-cor-2022-10-27