Novel Approach

C

iana’s lead therapy is based on Danegaptide, a drug that can both treat Diabetic Retinopathy and prevent disease progression.

Unlike the other injectable eye therapies that only block a single growth factor (VEGF) and limit edema, Danegaptide can stabilize and protect retinal capillaries from structural breakdown, and prevent vascular leakage and retinal edema.

Used as a monotherapy in moderate to severe disease or in combination with the anti-VEGF therapies in severe disease, Danegaptide is well positioned to become a front-line treatment to combat vision loss and blindness in Diabetic Retinopathy.

Facts on Diabetic Retinopathy

Better treatments are needed to prevent vision loss and blindness

Growing Problem

Diabetic retinopathy (DR) is the leading cause of blindness among working age adults. Globally there are 463 million adults living with diabetes, and this number is expected to increase to 700 million by 2045 according to the International Diabetes Federation [www.idf.org]. Over 125 million of these patients with diabetes have DR. Driven by the increased prevalence of diabetes and the aging 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 in the developed world. [ADA 2018].

American Diabetes Association (ADA).’ Economic Costs of Diabetes in the U.S. in 2017’. Diabetes Care 2018 41: 917–928

Vision Loss

Diabetic retinopathy is observed in approximately 30% of all patients with diabetes [Lee 2015]. This eye complication of diabetes is associated with a high risk of developing permanent vision loss. With long lasting diabetic disease, significant vision loss or blindness occurs in up to 5% of the patients with diabetic retinopathy [Lee 2015]. With the global increase in the incidence and prevalence of diabetes, the number of individuals with diabetic retinopathy continues to rise with an estimated 30 million diabetic patients suffering from different stages of diabetic retinopathy in the US and Europe alone.

Lee, R et al. (2015). ‘Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss’. Eye Vis (Lond). 2015 30:2-17

Cause of Blindness

The hallmark of diabetic retinopathy is that high glucose and other stressors damage the small blood vessels and capillaries of the eyes. High circulating glucose levels leads to endothelial cell and pericyte uncoupling and capillary break-down with resulting regional areas of ischemia in the back of the eye. Importantly, these areas of capillary breakdown represent damaged retinal tissue resulting permanent vision loss. Although patients may not notice this initially in the early stages of disease, these lesions functionally result in damaged peripheral vision and reduced night vision.

In more advanced stages of the disease, vascular leakage and diabetic macular edema (DME) may cause significant impairment of the central vision and if left untreated permanent vision loss may continue to progress into blindness.

Based on the global high prevalence of diabetes and the limited availability of effective disease control and treatments, diabetic retinopathy is today the leading cause of blindness in working age adults.

Early Symptoms

In the early stages of diabetic retinopathy (DR), there are limited signs and symptoms of disease, and consequently all patients with a diagnosis of diabetes should have their eyes examined by a physician at least annually to check for diabetic retinopathy and monitor disease progression. Even at these early stages of diabetic retinopathy, permanent damage to the retinal tissue has already occurred. Thus, there is a very large medical need for developing more effective therapies that can both treat diabetic retinopathy and reverse the disease pathology which otherwise leads to retinal capillary break-down and the associated tissue loss in the neurovascular structures of the eye resulting in permeant vision loss.

Late Therapies

Today, laser photocoagulation, steroids and anti-vascular endothelial growth factor (anti-VEGF) therapies are the main treatment options for diabetic retinopathy. However, these treatments have limited efficacy and can result in severe adverse events including visually threatening complications from pan-retinal photocoagulation and other toxicities [Falavarjani 2013 and Russell 1985]. The leading anti-VEGF therapies are primarily used to treat diabetic macular edema (DME), which is a serious complication of DR that leads to central vision loss and is most prominent in the later stages of disease.

The greatest unmet medical need is better identification and treatment of patients with moderate to severe diabetic retinopathy before the progressive retinal capillary break-down occurs and these early lesions cause vascular leakage, edema and permanent vision loss.

Falavarjani, K.G. and Q.D. Nguyen (2013). ‘Adverse events and complications associated with intravitreal injection of anti-VEGF agents: a review of literature’. Eye (Lond) 2013: 27(7): 787-94

Russell, P.W et al. (1985). ‘Visual function after pan-retinal photocoagulation: a survey’. Diabetes Care, 1985 8(1): 57-63

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