DR commonly refers to diabetic retinopathy, a diabetes-related retinal disease that can progress from non-vision-threatening changes to proliferative disease and macular edema. It is a significant cause of vision loss and requires screening and timely treatment. Disease burden in the U.S. is substantial.
A meta-analysis in BMC Ophthalmology found distinct gut microbiome compositional and functional alterations in diabetic retinopathy. The review identified depleted SCFA-producing bacteria, enriched pro-inflammatory bacteria, and dysregulated metabolic pathways.
Samsung Bioepis reached settlement agreements with Regeneron and Bayer for its aflibercept biosimilar OPUVIZ, enabling U.S. launch in January 2027 and staged international rollout beginning early 2026.
Zydus Lifesciences plans to launch Semaglutide injection in India after patent expiry and introduced ANYRA, India's first indigenous Aflibercept biosimilar. The USFDA cleared the company's Ahmedabad injectable facility with zero observations.
The FDA has approved an expanded label for Sandoz's aflibercept biosimilar Enzeevu to include multiple retinal indications beyond its original approval for neovascular age-related macular degeneration. The product is expected to launch in the US in Q4 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT04078672 |
Retinal Imaging Using NOTAL-OCT V3.0 |
COMPLETED | NA |
