Kodiak Sciences' experimental drug Zenkuda achieved 62.5% response rate in diabetic retinopathy trial with 85% reduction in sight-threatening complications. The company plans to accelerate FDA submission while preparing for wet AMD study readout in Q3 2026. Shares surged 68.6% following the positive late-stage results.
Ocugen reported Phase 2 data for its geographic atrophy gene therapy OCU410 showing 31% lesion growth reduction versus control. The company plans Phase 3 initiation in Q3 2026 and maintains its goal of three BLA filings in three years. Shares fell 11.48% following the data release which trailed earlier interim results.
Xbrane Biopharma reported full year 2025 revenue of SEK 152.4 million and a profit of SEK 127.2 million, driven by a SEK 168.9 million gain from the Alvotech transaction. The FDA issued a Complete Response Letter for the company's ranibizumab biosimilar application in October.
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.
Samsung Bioepis and Regeneron reached a settlement allowing U.S. launch of Opuviz, an aflibercept biosimilar, in January 2027. The agreement resolves a patent dispute that began in late 2023.
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RECRUITING | NA |
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COMPLETED | NA |
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Real-world of AI in Diagnosing Retinal Diseases |
RECRUITING |
