Diabetic Macular Edema
Diabetic Macular Edema (DME) is a complication of DR where the macula swells with fluid leaked from the damaged blood vessels as a result of worsening diabetic retinopathy. It is one of the most common reasons for blindness in diabetics, affecting approximately 750,000 patients. DME may cause blurriness in the center of vision, the appearance of straight lines as wavy, colors that look dull or washed out, or blind spots. The pathogenesis of DME involves vascular leakage, retinal ischemia, and release of vasoproliferative growth factors and inflammatory mediators. Earlier treatment options to prevent or delay vision loss for patients with diabetic eye disease are important. APX3330’s safety profile, pharmacokinetic properties, and molecular target engagement data observed in clinical trials and its drug exposure in the retina seen in mouse models, combined with a unique oral tablet formulation, suggest its potential to reduce the frequency of anti-VEGF treatments and increase compliance for better outcomes.
Other Indications: Wet Age-Related Macular Degeneration and Retinal Vein Occlusion
Age-Related Macular Degeneration (AMD) is a common eye condition affecting 11 million individuals in the US and 170 million globally, mostly over the age of 55 years. It is a progressive disease affecting the central portion of the retina, known as the macula, which is the region of the eye responsible for sharpness, central vision and color perception. Wet AMD (wAMD) is an advanced form of AMD characterized by neovascularization and fluid leakage under the retina. It is the leading cause of severe vision loss in patients over the age of 50 in the United States and EU. While wAMD represents only 10% of the number of cases of AMD overall, it is responsible for 90% of AMD-related severe vision loss. Untreated or undertreated wAMD results in further blood vessel leakage, fluid in the macula, and ultimately scar tissue formation, which can lead to permanent vision loss, or even blindness, as a result of the scarring and retinal deformation that occur during periods of non-treatment or undertreatment. Similar to severe DR and DME, current therapy for wAMD consists of intravitreal anti-VEGF injections, which have a number of side effects. Based on APX3330 targeting Ref-1 and reduction of VEGF production, it has potential use in wAMD. Further, to enter the wAMD injectable market, Ocuphire is considering the utility of second generation product candidates of APX3330, such as APX2009 and APX2014, in intravitreal formulation.