Real-World Outcomes of Intravitreal Ranibizumab Biosimilar (Ximluci) Therapy in nAMD Patients: A Single-Center Retrospective Study

PURPOSE To assess injection patterns, structural, functional and safety outcomes in patients receiving Ximluci intravitreal (IVT) injections for neovascular age-related macular degeneration (nAMD) in a real-world clinical setting. SETTING / VENUE A single center retrospective chart analysis of nAMD patients undergoing intravitreal ranibizumab biosimilar Ximluci treatment at the Hospital of Lithuanian University of Health Sciences Kaunas Clinics between 20th of March 2023 and 22rd of March 2024. METHODS Data collected included follow-up visits, injections administered, best-corrected visual acuity (BCVA), central subfield thickness (CST), and serious adverse events. BCVA was measured in Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores, CST in microns. Baseline BCVA intervals of the subgroup evaluation (≤55 letters, 56–68 letters, ≥68 letters) were selected for the analysis of BCVA change. Statistical analysis was performed using SPSS 29.0.0 software. A p value <0.05 was considered statistically significant. RESULTS A total of 467 eyes of 430 patients were analyzed. The median follow-up duration was 207 days (min 30; max 345). During the follow-up eyes received a median of 4 injections (min 2; max 7). The mean interval between the injections was 9.14 ±3.49 weeks. The mean CST at the end of the follow-up (268.94 ±67.83 μm) was 30.81 ±81.51 μm lower than the mean baseline CST (299.75 ±84.49 μm) (p < 0.01). A mean baseline BCVA was 58.03 ±15.62 ETDRS letters and 58.31 ±18.11 ETDRS letters at the end of the follow-up. In the groups with baseline BCVA of 56-68 and ≥68 ETDRS letters, the difference between the mean baseline BCVA and the mean end of the follow-up BCVA was not statistically significant. At the end of the follow-up, BCVA improved by 2.36 ±13.43 ETDRS letters in the group with baseline BCVA of ≤55 ETDRS letters, with 21.7% eyes of the group gaining ≥15 letters (p = 0.03). In 71.3% of eyes, BCVA either improved (gain of ≥5 letters) or remained stable (change of ≤4 letters). No cases of endophthalmitis following Ximluci IVT injections were recorded in this study over the follow-up period. CONCLUSIONS In a real-world clinical setting, the intravitreal ranibizumab biosimilar Ximluci proved effective for nAMD, with the majority of eyes either gaining or maintaining vision. Ximluci also demonstrated effectiveness in enhancing structural outcomes by reducing CST. Additionally, it proved to be safe, with no safety concerns.