STATUS: Phase I Enrolling | IND# 170554 [CALL OUT BOX]
Diabetic macular edema is the most common cause of vision loss in diabetic retinopathy, prevalent in over 25% of people with diabetes and affecting nearly 10 million individuals in the US. The standard of care is frequent intravitreous injections of VEGF inhibitors, which are expensive and place a significant burden on the patient. Activation of the inflammasome is now thought to be an important driver of DME, with circulating inflammasome proteins and intraocular cytokines elevated in these patients. A randomized, double-blind, placebo-controlled clinical trial reported that oral lamivudine, an FDA-approved HIV drug that also inhibits inflammasome activation, significantly improved vision in patients with poor sight due to DME. Lamivudine's long-term toxicity issues make it unsuitable for DME treatment. K9 is a derivative of lamivudine designed to avoid those toxicities. An oral therapy that achieves comparable efficacy avoids the necessity of frequent injections into the eye entirely. A clinical trial of oral K9 in DME is underway.