DIABETIC RETINOPATHY MARKET ANALYSIS

Key Developments

• In June 2023, Eyenuk, Inc., a global leader in AI-powered eye screening and disease monitoring, announced that it received the USFDA clearance for its Topcon NW400 retinal camera integrated with the EyeArt AI system. This clearance enables autonomous AI-based detection of diabetic retinopathy, solidifying Eyenuk’s position as a pioneer in leveraging AI for retinal disease management.
• In January 2023, Eyenuk, Inc. achieved a significant milestone by obtaining European Union Medical Device Regulation (MDR) certification for its EyeArt AI eye screening system. The certification extends its capabilities to detect diabetic retinopathy, age-related macular degeneration, and glaucoma, reflecting Eyenuk, Inc. dedication to advancing AI-driven healthcare solutions worldwide.
• In June 2022, Regeneron Pharmaceuticals, Inc., a leading biotechnology company focused on innovative treatments for serious diseases, announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Application (sBLA) for EYLEA (aflibercept) Injection. The application proposed a 16-week 2 mg dosing regimen, following initial monthly doses, for patients with diabetic retinopathy (DR).
• In February 2022, REGENXBIO Inc., a pioneer in gene therapy utilizing its NAV Technology Platform, reported additional positive interim data from the Phase II ALTITUDE trial of RGX-314. This trial evaluates RGX-314 for treating diabetic retinopathy (DR) in patients without center-involved diabetic macular edema (CI-DME) through in-office suprachoroidal delivery.