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MACUSTAR receives Letter of Support from EMA

27 April 2022

The MACUSTAR project has received a second Letter of Support from the European Medicines Agency (EMA) for its work on new measures to assess the eye disease age-related macular degeneration in clinical trials. The MACUSTAR project is supported by the Innovative Medicines Initiative (IMI), a partnership between the European Union and the European pharmaceutical industry, and is an ECRIN coordinated study.

People with age-related macular degeneration (AMD) gradually lose their central vision in both eyes. It is a leading cause of blindness and as the population ages, incidence is expected to rise. Today, treatment options are extremely limited. Dry AMD, including the intermediate AMD (iAMD) stage, therefore represents a huge unmet need.

One barrier to the development of new treatments is the lack of clinical endpoints capable of determining the effectiveness of treatments under development. Put simply, current tests do not detect all of the sight problems experienced by people with earlier stages of the disease (e.g. iAMD). Furthermore, there is currently no way to identify which patients with iAMD are at greatest risk of progressing towards advanced AMD.

 

"MACUSTAR project"About MACUSTAR

MACUSTAR was set up to develop and validate examinations that are capable of accurately detecting changes over time. It has developed a suite of markers and measures that could be used to assess how well a potential treatment works. In 2018, the EMA issued a first Letter of Support to the project in which they endorsed the project’s approach to developing and evaluating these measures. Since then, the project has completed its cross-sectional study, which was designed to assess the ability of the measures to discriminate between patients with different stages of AMD. The results of the cross-sectional study were promising, and EMA has now provided positive feedback on the results in a new Letter of Support.

 

MACUSTAR is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.