Diabetic Retinopathy
About Diabetic Retinopathy
Diabetes, a worldwide epidemic, is the leading cause of blindness among adults age 20-74. Diabetic retinopathy (DR) is a diabetes complication that affects the eyes, affecting over 7 million patients in the U.S. alone, in which chronically elevated blood sugar levels cause damage to blood vessels in the retina. There are two major types of DR:
- Non-proliferative DR, or NPDR. NPDR is an earlier, more typical stage of DR and can progress into more severe forms of DR over time if untreated and if exposure to elevated blood sugar levels persists.
- Proliferative DR, or PDR. PDR is a more advanced stage of DR than NPDR. It is characterized by retinal neovascularization and, if left untreated, leads to permanent damage and blindness.
When DR is in its early stages, blood vessels in the retina are damaged and can begin to leak fluid into the retina, a problem called diabetic macular edema (DME). In advanced stages, new and abnormal blood vessels form which may break and bleed. Fluid and hemorrhage interfere with vision and may further cause irreversible visual impairment due to retinal scarring and even retinal detachment. Even though biologic injection therapies have been approved for DR and treatment is possible, patients with DR are not widely treated in this early stage of the disease.
Market Landscape
7+M
U.S. prevalence
How APX3330 Can Help DR
We believe that APX3330’s oral delivery could be preferred over current invasive methods, and it has the potential to be used as monotherapy (non-proliferative or early proliferative stages of diabetic retinopathy) or as an adjunct therapy (advanced stages).
Diabetic Macular Edema
About 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.
Market Landscape
750K
U.S. prevalence
How APX3330 Can Help DME
APX3330’s safety profile, pharmacokinetic properties, molecular target engagement data observed in clinical trials, and drug exposure in the retina seen in mouse models, combined with a unique oral tablet formulation, suggest potential to reduce the frequency of anti-VEGF treatments and increase compliance for better outcomes.
Wet Age-related Macular Degeneration
About Wet Age-related Macular Degeneration
Age-Related Macular Degeneration (AMD) is a common eye condition affecting 11 million individuals in the U.S. 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.
Market Landscape
11M
U.S prevalence
How APX3330 Can Help wAMD
Based on APX3330 targeting Ref-1 and reducing 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.