Also known as: aflibercept-yszy, Eylea HD, Opuviz, OPUVIZ
Aflibercept is a VEGF-targeting biologic medicine marketed as Eylea and Zaltrap for ophthalmic and oncology indications. It is used for wet age-related macular degeneration and for metastatic colorectal cancer in specific combination regimens. It acts as a decoy receptor that inhibits VEGF signaling and angiogenesis.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07496567 |
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003) |
RECRUITING | PHASE2/PHASE3 |
| NCT07482176 |
Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS) |
RECRUITING | PHASE3 |
| NCT07440225 |
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002) |
RECRUITING | PHASE2/PHASE3 |
| NCT07390253 |
Switch From 2mg Aflibercept to 8mg Aflibercept in Patients With Neovascular Age-related Macular Degeneration |
ACTIVE_NOT_RECRUITING | |
| NCT07317934 |
Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR) |
RECRUITING | PHASE3 |
| NCT06856577 |
Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06850922 |
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT06839339 |
Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD |
NOT_YET_RECRUITING | PHASE2 |
| NCT06556368 |
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06495918 |
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration |
ACTIVE_NOT_RECRUITING | PHASE3 |
