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A personalized treat-and-extend–based regimen presented at ARVO 2023 suggested the long-term potential of faricimab to reduce the treatment burden for patients with DME.
Treat-and-extend with faricimab in the phase 3 YOSEMITE and RHINE trials offers vision gains and extended durability over 2 years for patients with diabetic macular edema (DME), according to new research.
The analysis, presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) in New Orleans, Louisiana, suggested the potential for faricimab to reduce treatment burden for patients with DME, compared with currently available anti-vascular endothelial growth factor (anti-VEGF) therapies.
“In summary, this treat-and-extend algorithm that would use this personalized CST and visual acuity resulted in improved durability and was also safe for these patients,” presenting investigator Jennifer Lim, MD, Director of the Retina Service, University of Illinois at Chicago told HCPLive at ARVO 2023. “It resulted in the results that we saw with faricimab QPTI, which is a treat-and-extend regimen, in comparison to aflibercept Q8.”
A dual angiopoietin-2 (Ang-2) and vascular endothelial growth factor (VEGF)-A pathway inhibitor, faricimab may extend treatment durability beyond current anti-VEGF therapies for DME. The personalized treat-and-extend–based regimen was designed to evaluate the long-term potential of faricimab to reduce treatment burden for patients with DME while maintaining efficacy. In the YOSEMITE and RHINE trials, patients were randomized 1:1:1 to faricimab 6.0 mg treat-and-extend, faricimab 6.0 mg every 8 weeks (Q8W), or aflibercept 2.0 Q8W through week 100 (pooled n = 1891).
For the treat-and-extend arms, patients received fairicmab Q4W until central subfield thickness (CST) <325 µm was achieved at or after week 12. Then, once achieved, personalized treatment intervals could be extended by 4 weeks (up to Q16W), maintained, or reduced by 4 or 8 weeks (as long as Q4W) based on prespecified CST or best-corrected visual acuity (BCVA) criteria-driven decisions.
Among those randomized to faricimab treat-and-extend (pooled n = 632), data showed 62% achieved Q16W dosing and 78% achieved ≥Q12W dosing at week 96, while achieving comparable BCVA gains and greater anatomical benefits, including earlier and sustained fluid control through 2 years, versus aflibercept.
The analysis showed most patients treated with faricimab who achieved ≥Q12W dosing at week 52 (79%) maintained the dosing interval without a reduction below Q12W through week 96, and most patients who achieved Q16W dosing at Week 52 (76%) maintained Q16W dosing through Week 96. Additionally, only 3.9% of patients remained on Q4W dosing through the 2-year trials.
Disclosures: Jennifer I. Lim, MD reports having received consultant fees and financial support from Allergan, Iveric Bio, Regeneron, Roche/Genentech, and others.
Lim JI. Chen SJ, Steinle N, Jaffe GJ, Gerendas BS, Abreu F, Camino A, Gibson K, Jain N, Shildkrot E, Souverain A, Tang Y, Willis J, Haskova Z. Durable vision gains and greater fluid control with extended faricimab dosing vs aflibercept in patients with DME. Presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting; April 2023; New Orleans, LA.