A retrospective study to evaluate the early real-world evidence of brolucizumab in patients with neovascular Age-related Macular Degeneration (nAMD) in India

Age-related macular degeneration (AMD) is the leading cause of severe vision loss, affecting 10% to 13% of individuals over the age of 65 years in North America, Europe, Australia, and Asia. It is responsible for 8.7% of global blindness and its impact is especially severe in the developing countries like India. While representing only 10% to 20% of AMD cases, the neovascular AMD (nAMD) is responsible for 80% to 90% of severe vision loss and/or legal blindness in the overall AMD population across developed as well as developing countries. This condition is characterized by loss of central vision, visual distortion, as well as a loss of contrast and intensity of colors.

For more than a decade, intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has become mainstay in the nAMD management, and it has been found effective both in anatomical and functional outcomes. However, despite the successful outcomes with this therapy, frequent anti-VEGF injections can place a substantial burden on patients, caregivers, and physicians. Frequent injections, over a long period of time has direct impact on patient’s adherence to the treatment, which in turn hampers the visual and anatomical outcomes.

A newly developed anti-VEGF molecule for the nAMD treatment, brolucizumab (known as RTH258 in clinical trials), has demonstrated longer durability of treatment response as well as improved visual and anatomical outcomes through a 12-weekly (q12w) dosing regimen (drug information brochure is enclosed as appendix III) ; thus, having a potential to reduce treatment burden, which is an important therapeutic tool in the nAMD management. Brolucizumab is expected to improve long-term outcomes as well as help manage the patients with unsatisfactory treatment response to the currently available anti-VEGFs. With such promising observations from the pivotal clinical trials, brolucizumab has been also approved in India (as Pagenax® in July 2020) by the Drugs Controller General of India (DCGI) for the treatment of neovascular (wet) AMD.

Exploring the effect of brolucizumab in routine clinical practice can help determine its effect in the real-world settings. However, there is very limited data available on brolucizumab effectiveness and safety in real-world patient population in India. Thus, the objective of this study is to understand the early real-world effectiveness of brolucizumab treatment in terms of anatomical and functional outcomes, as well as its safety outcomes among Indian patients with nAMD.