Plain language summary about faricimab injections for people with macular edema due to retinal vein occlusion: results of the BALATON and COMINO studies

<b>What is this summary about?</b> This is a plain language summary of the 6-month results of two clinical studies called BALATON and COMINO. Both studies looked at whether a new drug called faricimab worked as well as an existing drug called aflibercept at improving the vision of people with macular edema due to retinal vein occlusion (RVO). RVO is caused by a blockage of the vein in the retina, which is a thin layer at the back of the eye. This leads to a leakage of fluid into the retina. Macular edema is the term given to a build up of fluid in the macula, an oval-shaped area in the central part of the retina that allows sharp vision. There are a number of treatments available for RVO that are typically given via an injection into the eye. Aflibercept is one such treatment, and it works by blocking a naturally occurring protein called vascular endothelial growth factor (VEGF). RVO causes an increase in the production of VEGF by the eye. Too much VEGF can cause the growth of abnormal, leaky blood vessels, as well as increase the leakiness of existing, damaged blood vessels. Faricimab is a new treatment that blocks VEGF and another protein called angiopoetin-2 (Ang-2), which also contributes to abnormal blood vessel growth and blood vessel leakiness in RVO and other similar diseases of the retina. The purpose of the BALATON and COMINO studies was to see whether faricimab worked as well as aflibercept and whether it could be another treatment option for people with macular edema due to the two main types of RVO (please see Page 4 for more detail). In the studies, a total of 1,282 patients across 22 countries received either a faricimab or aflibercept injection once a month for the first 6 months, and they did not know what treatment they received. At the end of 6 months, the studies looked at how much vision had improved with both drugs. <b>What were the results?</b> Faricimab injections were found to work as well as aflibercept injections as a treatment for people with macular edema caused by RVO. After the very first injection, patients on both drugs showed rapid improvements in their vision that were maintained over 6 months. Faricimab was well tolerated in patients with RVO, showing similar overall safety to aflibercept, with few and comparable side effects. The most common side effects in these studies overall were broken blood vessels in the eye, increased pressure inside the eye, and separation of the gel-like substance inside the eye from the retina. <b>What do the results of the study mean?</b> As a result of these two studies, faricimab was approved by the USA Food and Drug Administration (FDA), Japan’s Ministry of Health, Labour and Welfare (MHLW), the European Commission (EC) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in October 2023, March 2024, July 2024 and September 2024, respectively, for the treatment of RVO. This means doctors now have more options for treating people with macular edema due to RVO. Faricimab is also approved for the treatment of other diseases (diabetic macular edema and age-related macular degeneration) in over 95 countries in the world. This is an abstract of the Plain Language Summary of Publication article. View the full Plain Language Summary PDF of this article to read the full-text