Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Brolucizumab/50 μL · 3 trials · 2 indications
BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.
| Arm | Type | Description |
|---|---|---|
| Brolucizumab 6 mg | EXPERIMENTAL | Single intravitreal (IVT) injection of brolucizumab at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit |
| Aflibercept 2 mg | ACTIVE_COMPARATOR | Single IVT injection of aflibercept ophthalmic solution at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit |
| Brolucizumab 3 mg | EXPERIMENTAL | Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit |
| Name | Type | Description |
|---|---|---|
| Brolucizumab ophthalmic solution | DRUG | Ophthalmic solution for IVT injection administered as a 6 mg/50 µL dose |
| Aflibercept ophthalmic solution | DRUG | Ophthalmic solution for IVT injection administered as a 2 mg/50 µL dose |
| Brolucizumab 3 mg/50 μL | DRUG | Administered as an intravitreal injection |
| Brolucizumab 6 mg/50 μL | DRUG | Administered as an intravitreal injection |
Key Inclusion Criteria: * Provide written informed consent; * Active CNV lesions secondary to AMD that affected the central subfield in the study eye at Screening; * Total area of CNV \> 50% of the total lesion area in the study eye at Screening; * Intraretinal and/or subretinal fluid affecting the...
Brolucizumab/50 μL is an investigational small molecule being developed for the treatment of neovascular age-related macular degeneration, a condition that causes abnormal blood vessel growth in the eye. It is administered as an intravitreal injection and is currently in Phase 3 clinical development.
Brolucizumab/50 μL is being developed by Alcon Inc., a company traded on the stock exchange under the ticker symbol ALC. The drug is currently in Phase 3 clinical trials for the treatment of neovascular age-related macular degeneration.
Brolucizumab/50 μL is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of neovascular age-related macular degeneration.
Brolucizumab/50 μL has completed three clinical trials. Two Phase 3 trials, NCT02307682 and NCT02434328, compared the drug to aflibercept in patients with neovascular age-related macular degeneration. A Phase 2 trial, NCT02507388, evaluated its safety and pharmacokinetics. All trials have been completed.
Yes, Brolucizumab/50 μL is also known as RTH258. The clinical trials for this drug, including NCT02307682, NCT02434328, and NCT02507388, refer to it as RTH258. It is being developed by Alcon Inc. for neovascular age-related macular degeneration.