Faricimab demonstrates noninferiority to aflibercept for DME treatment in phase 3 studies
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Faricimab has met its primary endpoint in two global phase 3 studies, according to a press release.
YOSEMITE and RHINE investigated faricimab in patients with diabetic macular edema. In both studies, the drug was well tolerated, with no new safety signals, the release said.
When given every 8 weeks and at personalized dosing intervals up to 16 weeks, faricimab demonstrated noninferior visual acuity gains compared with aflibercept given every 8 weeks, according to the release.
Faricimab also met its secondary endpoint in more than half of patients in the personalized dosing arms, with those patients reaching an extended time between doses of 16 weeks at year 1.
“These positive results show that faricimab has the potential to offer lasting vision improvements for people with diabetic macular edema, while also reducing the treatment burden associated with frequent eye injections,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the release.
The long-term safety and tolerability of faricimab is being evaluated in the phase 3 Rhone-X study. In addition, the phase 3 TENAYA and LUCERNE studies are in progress to evaluate faricimab as a potential treatment for wet age-related macular degeneration.
Perspective
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The angiopoietin/tyrosine kinase with immunoglobulin-like and endothelial growth factor-like domains (Tie) pathway plays a key role in regulating vascular stability and inflammation under healthy and pathological conditions, and as such, it is a focus for the development of next-generation therapeutics for retinal vascular disorders. For more information on how this pathway works in concert with anti-VEGF, click here.
Both Regeneron and Genentech have investigated this pathway. Regeneron’s analysis on its combined aflibercept and angiopoietin-2 (Ang-2) inhibitor missed the primary endpoint but demonstrated a strong signal with regard to two-step retinopathy improvement in those with diabetic retinopathy. Genentech has advanced its bispecific molecular faricimab for the treatment of both neovascular age-related macular degeneration and diabetic macular edema. The molecule targets two distinct pathways: Ang-2 and VEGF-A.
The YOSEMITE and RHINE studies compared faricimab and aflibercept for DME. The studies each have three treatment arms, with participants randomly assigned to receive either faricimab or aflibercept at fixed 8-week intervals or faricimab at personalized intervals of up to 16 weeks, following a loading phase.
Both studies met their primary endpoint and showed that faricimab given every 8 weeks and at personalized dosing intervals of up to 16 weeks demonstrated noninferior visual acuity gains compared with aflibercept given every 8 weeks. Faricimab was generally well tolerated with no new safety signals identified. Of most interest was the secondary endpoint, which showed that more than half of the participants in the faricimab personalized dosing arms achieved an extended interval of 16 weeks by the first year. That is a remarkable achievement because most therapeutics to date have not been able to achieve this level of drug durability.
It is important to note that a durable treatment is an important outcome, especially in light of these disease states and the current pandemic. Our recent studies on patients who experienced an unintended lapse in anti-VEGF treatment (akin to what is happening in the pandemic) found worse vision and retinal anatomy despite restarting treatment. Durable therapeutics might alleviate these treatment gaps and improve long-term outcomes.
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