Plain language summary of publication of the 48-week results from the PULSAR study investigating how well a new dose of aflibercept works and how safe it is for people with wet age-related macular degeneration

Abstract

What is this summary about? • This is a summary of a publication about the PULSAR study, which was published in The Lancet scientific journal. • Wet age-related macular degeneration (or AMD) is a long-term eye disease in which abnormal blood vessels grow in the back of the eye. As these vessels leak fluid or blood, the word "wet" is part of the disease name. This affects the central part of a person's vision, which can make it hard for people to read, drive, or perform other daily activities. It is one of the main causes of visual loss in older people, and if it is left untreated, it can lead to rapid loss of vision. • People with wet AMD can be treated with anti-vascular endothelial growth factor (or anti-VEGF) medicine, given as an injection into the back of the eye. This type of medicine can improve vision by directly reducing the leakage into the macula and by stopping the growth of new, abnormal blood vessels. This leads to reduced swelling of the macula, which is measured by central retinal thickness. These therapies need frequent eye injections. One of the biggest difficulties for many people and their caregivers is that they need to keep up with visits for their injections that are often required to maintain good vision. • Aflibercept is an anti-VEGF medicine that health authorities across different countries have approved for the treatment of wet AMD, as well as other eye diseases, which we will not discuss in this material. People with wet AMD can receive injections of aflibercept 2 mg, given initially once per month for three months. After that, people usually receive treatment every 8 weeks, or sometimes less frequently, depending on their doctors' assessments of the disease state. • The PULSAR study was carried out to see if a higher, 8 mg, dose of aflibercept would provide the same treatment results as aflibercept 2 mg, but with the need for fewer injections. If fewer injections are necessary, this can potentially help patients and their caregivers keep up with treatment. • The PULSAR study involved a direct comparison of the two doses of this anti-VEGF medicine in patients with wet AMD who were placed into one of three treatment groups with different dosing intervals at random. What were the results? • Through the first year (or 48 weeks), participants who received injections of aflibercept 8 mg every 12 or 16 weeks after an injection once per month for three months, had improvements in vision that were similar to those of participants treated with aflibercept 2 mg every 8 weeks. • After the injection once per month for three months, at Week 16, there were fewer participants treated with the 8 mg dose who had abnormal fluid leakage in the macula compared to the 2 mg dose. • At Week 48, participants who received aflibercept 8 mg had similar decreases in the thickness of the retina in the central region as those treated with aflibercept 2 mg. • Most participants who received aflibercept 8 mg and completed 48 weeks of the study maintained their 12- or 16-week injection schedules, without needing to shorten the interval between injections. • Adverse events in participants treated with aflibercept 8 mg were also similar to those in participants treated with aflibercept 2 mg. What do the results mean? • Findings show that aflibercept 8 mg can improve vision to the same extent as aflibercept 2 mg in people with wet AMD, but with fewer injections than aflibercept 2 mg so that people can potentially keep up with their treatments more easily.

Keywords: aflibercept treatment; anti-VEGF treatment; neovascular age-related macular degeneration; ocular disease; retinal disease.