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Jul 24, 2026
A stem cell therapy for geographic atrophy improved vision in a phase Ib trial, and the first gene therapy for optic neuropathies was administered. Next-generation anti-VEGF agents are also extending treatment intervals in retinal vascular disease.
May 15, 2026
EyePoint's DSMC recommended continuing its Phase 3 wet AMD trials without protocol changes after a third review. Topline data for LUGANO are expected mid-2026, with LUCIA shortly after. The company ended 2025 with $300 million in cash and a runway into Q4 2027.
Aug 04, 2026
Biocon's Yesafili, an interchangeable aflibercept biosimilar, is now available in the U.S., while Zydus Lifesciences launched Anyra in India. Both aim to treat retinal diseases such as diabetic macular edema. Biocon plans further launches in the UK and other markets, as competition intensifies.
Jul 18, 2026
Axpaxli (OTX-TKI) met its primary endpoint in the SOL-1 Phase 3 trial, demonstrating superiority over aflibercept in preserving visual acuity in wet AMD patients at week 36. A single injection of the intravitreal hydrogel led to higher rescue-free rates and better fluid control, supporting potential for reduced treatment burden. Ocular Therapeutix plans to submit a New Drug Application to the FDA.
Jul 03, 2026
Bayer outlined its 2030 growth strategy at Pharma Media Day 2026, driven by AI partnerships, precision medicine, and a strengthened pipeline. The company aims for mid-single-digit growth from 2027 and 30% margins by 2030.
May 17, 2026
4D Molecular Therapeutics said 4D-150 is in Phase 3 for wet AMD and nearing Phase 3 in diabetic macular edema. The company reported rapid enrollment, 18-month treatment burden reductions and favorable safety data.
Apr 25, 2026
Alvotech said it will release first-quarter 2026 financial results on May 6, 2026, and host a webcast with live Q&A on May 7. The company said five biosimilars are already approved and marketed, with nine disclosed candidates in development.
Apr 18, 2026
The FDA approved updated labeling for Vabysmo to allow extended treatment of macular edema following retinal vein occlusion beyond six months. The label update removes the prior 6-month restriction and retains monthly 6 mg intravitreal dosing.
Apr 07, 2026
Biocon has launched denosumab biosimilars Bosaya and Aukelso in the United States following FDA approval with interchangeable designation. The products target osteoporosis and bone metastases, entering a market where denosumab products generated approximately $5 billion in U.S. sales in 2024. The launch represents a strategic expansion of Biocon's biosimilar portfolio amid competitive market conditions.
Mar 24, 2026
Sanofi has submitted a revised acquisition bid for Ocular Therapeutix ahead of pivotal Phase 3 trial results for AXPAXLI, a sustained-release treatment for wet AMD. The deal could position Sanofi to re-enter the ophthalmology market it previously abandoned. The acquisition would give Sanofi access to innovative hydrogel delivery technology with potential applications beyond eye disease.
Mar 13, 2026
Zydus Lifesciences launched ANYRA, India's first indigenously developed aflibercept biosimilar, on February 19, 2026, following an agreement with Regeneron Pharmaceuticals and Bayer for multiple ophthalmic indications.
Mar 12, 2026
Arcturus Therapeutics completed three 28-day inhaled mRNA cohorts for cystic fibrosis that were well-tolerated and showed early biological signals. The company is preparing a 12-week Phase 2 study with tightened eligibility criteria and expanded enrollment into Europe and the Middle East.
Mar 04, 2026
Ocular Therapeutix's Axpaxli outperformed low-dose Eylea in a Phase 3 trial for wet AMD, while Oculis Holding reported narrowed Q4 losses and expects Phase 3 trial readouts for OCS-01 in Q2 2026.
Mar 02, 2026
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.
Mar 02, 2026
Regeneron has consistently increased revenue over 35 years with blockbuster products like Dupixent and Eylea HD, while maintaining over a dozen phase 3 clinical trial candidates across multiple therapeutic areas.
Feb 27, 2026
Zydus Lifesciences launched ANYRA, India's first indigenous Aflibercept biosimilar for retinal conditions, and secured approval for a March 2026 day-one launch of generic semaglutide for diabetes and obesity treatment.
Feb 26, 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.
Feb 23, 2026
Ocular Therapeutix announced positive topline results from the SOL-1 Phase 3 superiority trial of AXPAXLI for wet age-related macular degeneration, meeting its primary endpoint with statistically significant improvements in vision outcomes compared to aflibercept.
Feb 18, 2026
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.
Feb 18, 2026
Arcturus Therapeutics will release fourth quarter and fiscal year 2025 financial results after market close on March 3, 2026, followed by a conference call at 4:30 p.m. Eastern Time.
