Living with DME

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Diabetic retinopathy (DR) affects approximately one third of adults with diabetes and is the leading cause of vision loss in the working age population. Diabetic Macular Edema (DME) is a severe vision-threatening complication of DR characterized by swelling of the retina and thickening of the macula, the part of the eye that is responsible for high-resolution vision, and affects approximately 750,000 patients in the US.

Patients with DME often suffer from blurred or distorted central vision, which can vary from minimal to significant visual loss in advanced cases. They may also see changes in color perception, with the symptoms usually being described as “faded” or “washed-out” colors.

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The current standard of care for DME require multiple anti-vascular growth factor (anti-VEGF) injections into the eye to preserve vision. Due to the invasive route of administration, there is a tendency to delay treatment until later in the disease course because long-term compliance with eye injection regimens can be a burden on patients. This, coupled with inadequate responsiveness in almost 50% of patients, leads to overall undertreatment and suboptimal vision outcomes in DME patients. At Rezolute, we are committed to providing alternative options for DME patients with the hope of preserving vision and improving the quality of life. We believe it is critical to involve the patient community and their care partners so that the result is both clinically meaningful and has a direct impact on improving quality of life.

We are developing a once daily oral therapy for the treatment of DME, that may have the potential to address inflammation and vascular leakage by targeting the kallikrein–kinin system. Since DME is a microvascular complication of diabetes, we believe that systemic exposure through oral delivery of a plasma kallikrein inhibitor (PKI) maybe more effective in getting sufficient quantities of drug and sustained kallikrein inhibition at the retinal microvasculature at the back of the eye. Further, as an oral therapy, we may have the potential to substantially change the therapeutic paradigm for patients suffering with DME by providing a convenient treatment option to encourage patients to initiate therapy sooner, adhere to prescribed treatment guidelines, and improve overall outcomes.

RZ402, our oral PKI in development for DME, recently announced results from the Phase 1b study. View Results.

Rezolute is planning to initiate a Phase 2a study later this year.