nAMD refers to neovascular (wet) age-related macular degeneration, in which abnormal blood vessels grow under the macula and leak fluid or blood, causing rapid central vision loss. It is the vision-threatening form of AMD.
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.
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.
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 |
|---|---|---|---|
| NCT06737354 |
Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD). |
ENROLLING_BY_INVITATION | PHASE1 |
| NCT06672536 |
Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD |
RECRUITING | PHASE1/PHASE2 |
| NCT05562947 |
A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD) |
RECRUITING | PHASE3 |
| NCT05407636 |
Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD |
RECRUITING | PHASE3 |
| NCT05262244 |
Targeted Fluorescence Imaging in AMD |
COMPLETED | PHASE1 |
| NCT05210803 |
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD |
ENROLLING_BY_INVITATION | |
| NCT04704921 |
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
