Results from FARETINA-DME indicate a majority of eyes with DME began extending treatment intervals after 1-2 initial doses of faricimab.
Early treatment extensions in patients with diabetic macular edema (DME) may indicate a positive anatomical response to faricimab, according to an analysis of the FARETINA-DME study.
The data, presented at the American Society of Retina Specialists (ASRS) 41st Annual Meeting, suggest a majority of eyes with DME identified in the IRIS registry with ≥6 months follow-up began extending treatment intervals after 1 - 2 initial doses.
“I think what these early results show are very, very promising because they suggest that early interval extension is not only possible but very likely for patients,” Durga Borkar, MD, an assistant professor of ophthalmology at Duke University Eye Center, told HCPLive at ASRS 2023.
The FARETINA-DME study aimed to describe real-world treatment patterns and early clinical response among patients with DME initiating faricimab using data from the American Academy of Ophthalmology’s IRIS registry. Inclusion criteria for the study included a documented diagnosis of DME and ≥1 faricimab injection after January 2022. To be included in the injection interval extension analysis and visual acuity analyses, patients were required to have ≥6 months of follow-up and ≥4 faricimab injections.
Noting the limitations of the real-world study, investigators were limited to EHR data captured in routine clinical practice and did not include standardized measurements of visual acuity, anatomical outcomes, or physician-dosing frequency rationale. In addition, early data may not reflect future treatment patterns.
The investigative team identified over 28,000 eyes in the IRIS registry that initiated treatment with faricimab between February – September 2022. After applying inclusion criteria, investigators identified 3,961 (14.0%) patient eyes that were eligible for the study. Of this population, 497 eyes (12.5%) were considered treatment-naive and had no anti-VEGF injections in the 12 months prior to faricimab initiation.
Patient demographics across the cohort revealed an average age of 68 years, with a slight predominance of male patients, and patients were mostly White; data showed 16% of patients were Black, Asian, or other race. The analysis showed that approximately 76% of previously treated patients were switched from aflibercept. The mean anti-VEGF injection frequency in the prior 12 months was nearly 6 injections approximately 7 weeks apart.
The analysis showed about 40% of eyes treated with faricimab through September 2022 had ≥6 months of follow-up. Investigators found most eyes with DME achieved an extended faricimab interval (>6 weeks) after 2 injections of faricimab. Specifically, 61.8% of previously treated eyes with ≥4 faricimab injections and 61.5% of treatment-naive eyes with ≥4 faricimab injections extended beyond 6 weeks within 1-2 injections.
Nearly half of patient eyes with DME initiated faricimab at 20/40 or better best-documented visual acuity (51% previously treated; 44% treatment-naive) In previously-treated eyes, visual acuity was shown to remain relatively stable. On the other hand, treatment-naive eyes experienced an improvement in visual acuity after 4 injections, with an approximately 4-letter gain after injection 3.
Watch an interview from ASRS 2023 with Dr. Borkar below:
Relevant disclosures for Dr. Borkar include Allergan, Glaukos, Iveric Bio, and Verana Health.