Our Focus

Diabetic Retinopathy (DR)

Diabetic retinopathy (DR) affects approximately 30 % of all patients with diabetes (Type 1 and Type 2) and is the leading cause of blindness among working age adults.

Globally there are 537 million adults living with diabetes, and this number is expected to increase to 783 million by 2045 according to the International Diabetes Federation (IDF). Today there are 93 million patients globally with some degree of DR according to the American Academy of Ophthalmology (AAO). Driven by the increased prevalence of diabetes and the ageing population in the developed world, the incidence of DR is expected to continue to rise, placing a huge economic and public health burden on these populations.

Globally there are 537 million adults living with diabetes, and this number is expected to increase to 780 million by 2045.

International Diabetes Federation (IDF)

Age-Related Macular Degeneration (AMD)

Age-related macular degeneration (AMD) affects approximately 25% of people older than 60 years of age and is the leading cause of blindness within the elderly population. In Europe alone, the incidence of late AMD is estimated to increase from 400,000 per year today to 700,000 per year in 2050 (Li, 2020).

In Europe alone, the incidence of late AMD is estimated to increase from 400,000 per year today to 700,000 per year in 2050.

Unmet Medical Need

There is a large unmet medical need to develop more effective and less burdensome therapies for patients and their caregivers. Patients should optimally be treated at an earlier stage of their disease to achieve better outcomes.

The leading therapies used today to treat both DR and AMD are based on repeated needle injections into the eyes and are burdensome with limited efficacy; only 30-40% of patients achieve optimal responses and 30% of patients do not respond to treatment (Virgili, 2018). Existing eye injection therapies, such as the anti-vascular endothelial growth factor therapies (VEGFs) have been clinically validated as it is known that increased levels of VEGF can cause vascular leakage and macular edema.

Breye is developing danegaptide as an oral therapy that targets these retinal pathologies, including those upstream of the anti-VEGF IVT injection therapies for patients with DR or AMD.

Solution

By targeting the core of the disease, Breye’s mission is to develop novel oral therapies, which are more effective and less burdensome, for the treatment of retinal vascular diseases such as DR and AMD.

The combined market for DR and AMD exceeds US$15 billion today and is expected to grow at a CAGR of 7% over the next several years. The sales for the current market-leading anti-VEGF product for treating late-stage DR and AMD manifestations exceeded US$8 billion in 2021.

The combined market for DR and AMD exceeds US$15 billion today is expected to grow at a CAGR of 7% over the next several years.