Real-world evidence of biosimilar Ranibizumab in management of neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macula oedema (DMO): Switches and treatment naive.

Abstract

Purpose : To analyse the real-world data of best-corrected visual acuity (BCVA) and central macular thickness (CMT) for patients who have been switched to biosimilar Ranibizumab from originator Ranibizumab, for treatment in nAMD and DMO. Treatment naïve patients started on biosimilar Ranibizumab were also analysed.

Methods : Single-centre retrospective analysis evaluated BCVA, CMT 6 months prior to switch, at baseline and 3 months post switching to biosimilar Ranibizumab. 3 loading doses were given to all the patients.

Results : The study analysed 181 eyes with nAMD, 49 eyes with DMO and 19 naïve nAMD patients.

Mean BCVA and CMT in nAMD patients 6 months prior to switch is 58.5 letters & 309.2 respectively, at baseline 56.8 & 311.4 respectively and vs 3 months post switch BCVA& CMT is 57.4 letters & 344.2 respectively.

No statistically significant difference in BCVA and CMT in both groups of nAMD patients (p-value 0.5 & 0.76).

Mean BCVA and CMT in DMO patients 6 months prior to switch is 61.06 letters & 385 respectively vs 3 months post switch BCVA & CMT is 60.1 letters & 373.6 respectively.

No statistically significant difference in BCVA and CMT in both groups of DMO patients (p-value 0.61 & 0.63) seen.

At 3^rd months, the mean gain in BCVA was 13.9 letters and mean reduction in CMT was 102.2 .

No adverse events were noted during this period.

An estimate savings of 56% on spend on the originator Ranibizumab has been established.

Patient satisfaction audit ongoing.

Conclusions : Biosimilar Ranibizumab has similar functional and anatomical outcomes with the same safety profile as the originator Ranibizumab in nAMD and DMO patients, resulting in considerable financial savings.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.