Dual inhibition with faricimab improves disease control in DME, neovascular AMD
Key takeaways:
- Faricimab was well-tolerated and had an acceptable safety profile in the phase 3 clinical trial program.
- Dual inhibition with faricimab may result in greater disease control vs. anti-VEGF therapy alone.
Faricimab demonstrated noninferior vision gains and improved anatomical outcomes among patients with diabetic macular edema and neovascular age-related macular degeneration vs. aflibercept, according to study data.
“Intravitreal anti-VEGF therapy is the standard of care for DME and neovascular AMD (nAMD); however, vision gains and anatomical improvements are not sustained over longer periods of treatment, suggesting other relevant targets may be needed to optimize treatments,” Hansjürgen Agostini, MD, senior physician in charge at the University of Freiburg Eye Center at Medical Center in Germany, and colleagues wrote. “Additionally, frequent intravitreal injections can prove a burden for patients and caregivers.
“As such, there remains a significant opportunity for improvement in treatment outcomes for patients with retinal vascular diseases, and a need for additional therapeutic strategies to reduce treatment burden and optimize vision outcomes for patients with DME and nAMD,” they added.
In a review published in Graefe’s Archive for Clinical and Experimental Ophthalmology, Agostini and colleagues examined the results from a phase 3 clinical trial program that assessed the safety, efficacy, pharmacokinetics and durability of dual VEGF-A and angiopoietin-2 (Ang-2) inhibition with faricimab-svoa (Vabysmo, Genentech/Roche) vs. anti-VEGF therapy with aflibercept among patients with DME and nAMD.
The phase 3 YOSEMITE and RHINE trials for DME and the phase 3 TENAYA and LUCERNE trials for nAMD demonstrated noninferior vision gains and improved anatomical outcomes with faricimab at 1 year compared with aflibercept, according to the researchers.
In the YOSEMITE and RHINE trials, they observed that eyes treated with faricimab achieved greater reductions in central subfield thickness (CST) as well as absence of both DME and intraretinal fluid vs. those treated with aflibercept.
They also found that faricimab was well-tolerated and demonstrated an acceptable safety profile that was comparable to that of aflibercept.
In the TENAYA and LUCERNE trials, reductions in CST were greater for faricimab vs. aflibercept from 0 to 12 weeks, according to the researchers.
At 1 year, CST outcomes achieved with faricimab were comparable to those achieved with aflibercept administered every 8 weeks, with 45% of patients who received faricimab every 16 weeks and 72% of those who received it every 12 weeks achieving these vision outcomes.
“The extended dosing intervals achieved with faricimab support the concept that Ang-2/VEGF-A-targeted therapies may address the unmet need for durable treatments that improve real-world outcomes and reduce the treatment burden compared with standard-of-care therapies for patients with retinal vascular diseases,” the researchers wrote.
Once again, they found that that faricimab was well-tolerated and had an acceptable safety profile in the TENAYA and LUCERNE trials.
Additionally, the researchers noted that vision gains, anatomical control and treatment durability were maintained throughout the second year of treatment with faricimab across the YOSEMITE, RHINE, TENAYA and LUCERNE trials.
“The promising results for patients with DME and nAMD suggest that faricimab may also be efficacious in other retinal vascular diseases,” they wrote.
Perspective
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Due to the multifactorial pathogenesis of DME and nAMD, VEGF-A monotherapy is unable to address all aspects of each disease.
This study assessed the potential benefits of faricimab in managing DME and nAMD, particularly its ability to target both VEGF-A, and Ang-2. Faricimab demonstrated noninferior vision gains compared with aflibercept, with an added advantage of extended dosing intervals. This is clinically significant as it could reduce the frequency of injections and improve patient compliance, ultimately optimizing overall treatment outcomes.
However, while the dual Ang-2/VEGF-A inhibition reportedly promoted vascular stability beyond that achieved with anti-VEGF alone, the study failed to explain why these did not translate into better visual outcomes. Additionally, although the study highlighted a reduced injection frequency, it did not fully explore long-term safety and efficacy.
Factors that could significantly influence outcomes, such as patient adherence, underlying health conditions and access to treatment, also were not sufficiently investigated, limiting the application of the study in everyday clinical settings.
Although faricimab represents a promising shift toward better disease management compared with anti-VEGF monotherapy, future studies should investigate patient-centered treatment variabilities and extend the study duration to confirm its long-term efficacy and safety.
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