Ranibizumab is marketed as LUCENTIS for intravitreal injection and is used for several retinal vascular diseases. Labeling describes it as a VEGF inhibitor, and indications include neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. U.S. labeling lists initial FDA approval in 2006.
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.
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.
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.
AAV-based gene therapy offers sustained intraocular delivery of anti-angiogenic agents with a single treatment for neovascular AMD, with leading clinical candidates including RGX-314, ADVM-022, 4D-150, and NG101.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07249216 |
Identification of Molecular Signals in Vitreous Humor Associated With Suboptimal Response to Vascular Endothelial Growth Factor (VEGF) Inhibition in Neovascular Age-related Macular Degeneration (nAMD) Within a Clinical Trial Setting |
RECRUITING | NA |
| NCT06957080 |
A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT06847542 |
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD |
RECRUITING | PHASE3 |
| NCT06771271 |
A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema |
COMPLETED | PHASE1 |
| NCT06571045 |
A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT06190093 |
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD) |
COMPLETED | PHASE3 |
| NCT06176352 |
A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05480293 |
This Study Will Compare the Efficacy and Safety of SCT510A Administered by Intravitreal Injection (IVT) With Ranibizumab in Patients With wAMD |
UNKNOWN | PHASE3 |
| NCT05282420 |
Ranibizumab Versus Aflibercept for CRVO in Young Patients. |
UNKNOWN | PHASE4 |
| NCT05222633 |
Anti-VEGF in Real-world |
UNKNOWN |
