Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
brolucuzumab IVT · 1 trial · 6 indications
Incidence between 20 and 24 h post-injection of clinically relevant treatment emergent changes in heart rate (HR), pulse rate (PR), QRS, and QTc (heart rate corrected QT using Fridericia's formula, QTcF) interval (ms). This is a composite endpoint capturing all 4 parameters and 3 time-points in one Outcome Measure.
| Arm | Type | Description |
|---|---|---|
| RTH258 | EXPERIMENTAL | Intravitreal injection |
| Name | Type | Description |
|---|---|---|
| brolucuzumab 6 mg IVT | BIOLOGICAL | Single intravitreal injection (IVT) of brolucizumab 6 mg |
Inclusion Criteria: * Signed informed consent MUST be obtained prior to participation in the study * Study eye is diagnosed with nAMD and deemed to be eligible for intravitreal injection at the discretion of the Investigator Exclusion Criteria: * Concomitant conditions or ocular disorders in the ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 7 | PHASE3 | Surabgene Lomparvovec, RGX-314, ABBV-6628 |
| Ocular Therapeutix Inc | OCUL | 3 | PHASE3 | OTX-TKI |
| 4D Molecular Therapeutics, Inc. | FDMT | 3 | PHASE3 | 4D-150 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Aflibercept, Pozelimab, Cemdisiran |
| Novartis AG Sponsored ADR | NVS | 5 | PHASE2 | Iptacopan, GT005, FWY003 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Hoffmann-La Roche | RHHBY | 10 | PHASE3 | Ranibizumab, Susvimo, RO7965032, OpRegen, Faricimab |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Adverum Biotechnologies, Inc. | ADVM | 4 | PHASE3 | Ixo-vec, ADVM-022 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-3007 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 938, Aflibercept |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Ocugen Inc | OCGN | 1 | PHASE3 | OCU410 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-033 |
| Bayer | BAYRY | 2 | - | Aflibercept |
Brolucuzumab IVT is an investigational monoclonal antibody given by intravitreal injection, meaning it is injected into the eye. It is being studied for age-related macular degeneration, including the wet form of the disease. It is also referred to as brolucuzumab 6 mg IVT, reflecting the 6 mg dose used in its clinical program.
Brolucuzumab IVT is being developed for age-related macular degeneration, including wet macular degeneration and related retinal conditions. The clinical program enrolled patients aged 50 years and older with wet AMD. It is an investigational therapy and has not been established as a marketed treatment for this indication.
Brolucuzumab IVT is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the 6 mg intravitreal formulation in patients with wet age-related macular degeneration.
Brolucuzumab IVT is in Phase 3 development. Its Phase 3 study has been completed, and the program is not currently listed with active trials. The drug remains investigational and is not described as approved for any indication.
Brolucuzumab IVT has been studied in the Phase 3 trial NCT03954626, titled a study to collect safety and ECG data on brolucizumab 6 mg intravitreal treatment in patients with wet AMD. That trial is completed, enrolled 14 patients, and was conducted in the United States and Puerto Rico.