Abstract :
Purpose: To evaluate the effectiveness and safety profile of Ranibizumab Biosimilar in Macular Neovascularisation and compare outcomes with patent Ranibizumab.
Materials and Methods: A retrospective analysis during the period 2017-2020 was conducted at a tertiary eye care centre in South Kerala on patients with wet AMD who had received Razumab, a biosimilar of Ranibizumab as a loading dose followed by PRN schedule. This was compared to a similar data obtained from patented Ranibizumab (Lucentis) during the same period. Endpoints analyzed included improvement in BCVA, proportion of patients with persistent IRF/SRF and complications at 1 year.
Results: Of 164 eyes analyzed 76 eyes received Razumab and 88 eyes received Lucentis with 32% and 50% males in each group. After the loading dose both drugs showed similar efficacy and the final vision (median logmar; 0.24 vs 0.17; p 0.189), presence of residual CME (31.6% vs 18.2%; p 0.469) and SRF (57.9% vs 61.9%; p 0.796) were similar in both groups at 12 months. The mean number of injections was 8 in the Razumab group comparable to Lucentis (6.4). Acceptability and less drop outs were seen in Razumab patients compared to Lucentis. Though some eyes developed mild uveitis (4.3%) with one of the initial batches of Razumab, it was not evidenced later. No other safety concerns or side effects were reported with the biosimilar.
Conclusions: The Biosimilar Razumab is as effective as the patent molecule in reducing macular fluid and improving visual acuity in patients with macular neovascularization over 1 year on a PRN schedule. Being cheaper it is a safe alternative for patients who often need long term management.
Keyword :
Ranibizumab, Razumab, Biosimilar, Lucentis.