Study Shows Promise of Extending Faricimab Treatment to 20 Weeks, Successful at Weeks 12, 16

Credit: The Research Institute of St. Joe's Hamilton

A new study found personalized faricimab dosing may allow patients with neovascular age-related macular degeneration (nAMD) to increase to > 12 weeks or 16 weeks, with potential for reaching 20 weeks.1

“If Q20W week dosing was allowed in the treat extent phase, 56% of faricimab-treated patients during the treat extent phase would have been extended to q20 week dosing,” said the investigator, Varun Chaudhary, MD, of the Alcon Laboratories, Inc.

Chaudhary presented the team’s study at the 127th Annual American Academy of Ophthalmology (AAO) conference in San Francisco, California. The study followed a TENAYA and LUCERNE trial design. After 4 initial dosing in 4 weeks (q4), patients could extent their treatment to 8 (q8), 12 (q12), or 16 (q16) weeks through week 60. At week 60, patients could extend treatment by 4 weeks every 16 weeks with a minimal interval of 8 weeks. Treatment extension was based on central subfield thickness, best-corrected visual acuity, and macular hemorrhage criteria.

Michael Engelbert, MD, PhD, another investigator of the study, spoke to Modern Retina at Retina Society 2023 about his personal concerns beginning the trial. Since other drugs do not commonly reach 4 months, Engelbert was concerned his patients on faricimab already on 4 months would return to shorter intervals.2

“It was nice to see that in the second year of the study, for most patients, whether they were on Q8, Q12, or Q16 at the end of Year 1, the vast majority, the decision was made to either maintain or to extend those intervals,” Engelbert said. “That was for about 90% of patients.”

Over 2 years, patients on faricimab reached disease control with fewer injections. Also, at the end of year 2, roughly 80% of patients on faricimab reached > Q12W dosing 63% achieved q16 dosing. In year 1, 78.7% of participants had > Q12W dosing, and 77.8% had > Q12W dosing. Q16W had higher percentages than Q12W in both year 1 and year 2. In year 1, Q12W was 33.4% and Q16W was 45.3%. In year 2, the Q12W was 14.7% and the Q16W was 63.1%.1

The treat-and-extent dosing in year 2 allowed more patients to reach Q16W dosing. Patients both on > Q12W and Q16W dosing had stable best-corrected visual acuity and central subfield thickness reductions throughout 2 years.

Chaudhary included a real-world case example in his presentation. The 88-year-old female patient with nAMD switched to faricimab and had improved best-corrected visual acuity and central subfield thickness. The patient began with a baseline best-corrected visual acuity of 20/400.

Previously, the patient had been on bevacizumab for 3 months and aflibercept for another 3 months. After taking bevacizumab for 2 weeks, the best-corrected visual acuity was 20/100, and the central subfield thickness was 280 µm. Then, after taking aflibercept for 3 months, the best-corrected visual acuity was 20/100, and the central subfield thickness was 532 µm. For faricimab, however, she had a best-corrected visual acuity of 20/80 after 7 weeks, 20/60 after 14 weeks, and 20/50 after 22 weeks. Her central subfield thickness was 20 µm after 7 weeks, 282 µm after 14 weeks, and 204 µm after 22 weeks.

Patients on faricimab had a complete resolution of subretinal and rapid extension of treatment interval from Q9W on a vascular endothelial growth factor treatment to > Q16W with faricimab, showing faricimab’s success.

Even though participants either were on Q12 or Q16 week doses, the investigators examined Q20 potential. Nearly half (56%) of patients on faricimab met criteria for Q20W dosing intervals while 44% did not. This matches with the findings of another study following a YOSEMITE and RHINE trial approach, which found faricimab treat-and-extend dosing provided durable efficacy for over 2 years—and 56% of patients on faricimab met extension criteria and could potentially extend to 20-week dosing.3

“Patients always on extended faricimab treatment demonstrated robust disease control through 2 years with stable outcomes that may allow for potential interval extension to q20 weeks,” Chaudhary said. “Greater than 50% of faricimab-treated patients met criteria for potential q20 week dosing intervals during the treatment extent phase.”1

References

1. ^{Chaudhary, V, Ambresin, A, Souverain, A, et al. Personalized Faricimab Dosing Increased the Proportion of Patients With nAMD Achieving Q16W Dosing in TENAYA/LUCERNE. Presented at the 2023 American Academy of Ophthalmology Annual Meeting, November 3 – 6, 2023.}
2. ^{Stevenson, S. Retina Society 2023: Personalized faricimab dosing shows promise in extending wet AMD treatment intervals. Modern Retina. https://www.modernretina.com/view/retina-society-2023-personalized-faricimab-dosing-shows-promise-in-extending-wet-amd-treatment-intervals-. Accessed November 10, 2023.}
3. ^{Iapoce, Connor. YOSEMITE/RHINE: Faricimab Treat-and-Extend Shows Durability in DME Over 2 Years. HCPLive. https://www.hcplive.com/view/yosemite-rhine-faricimab-treat-extend-durability-dme-over-2-years. Accessed November 10, 2023.}