Durga Borkar, MD, MMCi, discussed the FARETINA-DME study during the 2023 ASRS meeting in Seattle, Washington.
Durga Borkar, MD, MMCi, spoke about the FARETINA-DME study at the 2023 ASRS meeting in Seattle, Washington.
Editor's note - This transcript has been edited for clarity.
Hi, my name is Durga Borkar. I'm a vitreoretinal surgeon at Duke University. Thank you so much for the opportunity to share the exciting new results of the FARETINA-DME study. FARETINA-DME is the largest ongoing real-world data study utilizing data from the IRIS registry. IRIS registry is the American Academy of Ophthalmology's EHR registry containing data on over 75 million patients.
To be included in FARETINA-DME, patients had to have at least 1 injection of faricimab between February and September of 2022, and a documented diagnosis of diabetic macular oedema utilizing ICD codes. To be included in our visual acuity and extension analyses, we required that these patients had at least 6 months of follow up after their first faricimab injection and at least 4 faricimab injections in the follow up period.
When we looked at our cohort, we identified over 28,000 patient eyes in the IRIS registry that had an injection of faricimab. After applying all ie criteria, and making sure that all real data was available, there were over 3,000 patients eyes that were eligible for inclusion and FARETINA-DME. What was interesting is that only 12.5% of these patient eyes were treatment naive. We define that as patient eyes that had no anti-VEGF treatment in the 12 months prior to the index state.
What we saw was that, on average, these patients were about 68 years old, predominantly Caucasian population, and their primary insurance status was Medicare. When we looked at the visual acuity, we saw that they actually had relatively good visual acuity compared to clinical trials. Approximately half of both treatment-experienced and treatment-naive eyes had 20/40 or better best documented visual acuity.
The treatment-naive eyes ended up gaining approximately 4 letters of visual acuity between the first injection and the third injection. Treatment-experienced eyes remained about the same.
The interval extension analysis was even more interesting. We saw that approximately 62% of treatment-experienced and treatment-naive eyes were able to extend their injection interval beyond 6 weeks within the first 1 to 2 injections. What this study showed us is that early durability results are quite impressive for faricimab. And we look forward to allowing the dataset to mature to gain additional results on both durability, safety and some anatomical outcomes. Thank you.