Diabetic Macular Edema (DME) is a vascular complication of diabetes and a leading cause of blindness in the US and elsewhere. Chronic exposure to high blood sugar levels can lead to inflammation, cell damage, and the breakdown of blood vessel walls. Specifically, in DME, blood vessels behind the back of the eye become porous and permeable leading to the unwanted infiltration of fluid into the macula. This fluid leakage creates distorted vision and left untreated, blindness.
The current standard of care to treat DME patients is a regimen of anti-vascular growth factor (anti-VEGF) injections into the eye. As a result of this invasive route of administration, there is a tendency to delay treatment until later in the disease course and when administered, patients often do not adhere to the recommended frequency of injections that are sufficient to alter the progression of the disease. Further, some patients have an inadequate response to anti-VEGF injections or experience serious side effects. All of these factors lead to undertreatment overall and suboptimal vision outcomes in DME patients.
RZ402 is designed to be a once daily oral therapy for the treatment of DME. Unlike the anti-VEGF therapies, RZ402 targets the Kallikrein–Kinin System in order to address inflammation and vascular leakage. We believe that systemic exposure through oral delivery is critical to target the microvasculature behind the back of the eye. Further, as an oral therapy, RZ402 has the potential to substantially change the therapeutic paradigm for patients suffering with DME by providing a convenient, self-administered treatment option to encourage patients to initiate therapy sooner, adhere to prescribed treatment guidelines, and improve overall outcomes.