Early Versus Delayed Introduction of Faricimab for Initially Treatment-Naïve Diabetic Macular Edema: A Real-World Pilot Study

Background: Faricimab is one of the most potent anti-vascular endothelial growth factors used in the management of diabetic macular edema (DME). However, real-world benefits regarding its timing and efficacy are still being explored. Methods: This retrospective non-randomized pilot study aimed to evaluate the efficacy of intravitreal faricimab in the treatment of DME. Eyes initially treatment-naïve for DME with a follow-up of 1 year were grouped as: group 1, where faricimab was introduced within the first six months after the start of treatment; group 2, where it was initiated six or more months after treatment with other drugs. Study parameters included changes in best corrected visual acuity (BCVA) and optical coherence tomography based structural parameters within the 6 × 6 mm optical coherence tomography (OCT) scan regions. Results: Forty-two eyes from 26 patients were analyzed. No statistically significant differences were observed between the groups in cluster-weighted proportions of intra- or sub-retinal fluid, retinal thickness or volume parameters, although group 1 showed modest numerical benefits. SRF showed a trend towards qualitative reduction in group 1, although IRF showed persistence in both groups. Adjusted linear mixed-effects modeling demonstrated no significant impact of early faricimab initiation on functional and anatomical outcomes, which appeared to be influenced by the baseline BCVA, glycemic control, and the number of injections, nullifying the benefits. Conclusions: Faricimab demonstrated modest anatomical improvements with earlier treatment in eyes initially treatment-naïve for DME. Further prospective studies are indicated to assess the treatment strategy and the timing of introduction with faricimab in such eyes.