Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ESBA1008 · 3 trials · 1 indication
A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline: * Greater than or equal to 4 letter gain in BCVA at Day 14 * Greater than or equal to 4 letter gain in BCVA at Day 28 * Greater than or equal to 80 micron decrease in CSFT at Day 14 * Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis.
This outcome measure was used to compare the ESBA1008 and EYLEA groups in regards to fluctuations in treatment effect during the maintenance phase with 8-week treatment cycles (ie, to evaluate treatment effect stability during the maintenance phase). BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.
CSFT is a retinal thickness measurement and was measured with SD-OCT. A thickening of the retina is characteristic of wet AMD, and a reduction in CSFT may indicate an improvement in ocular health. One eye (ie, study eye) contributed to the mean.
| Arm | Type | Description |
|---|---|---|
| ESBA1008 1.2 mg/10 μL | EXPERIMENTAL | Cohort 1: One intravitreal injection on Day 0, followed by one intravitreal (IVT) injection of ESBA1008 6 mg/50 μL on Day 28 |
| ESBA1008 1 mg/8.3 μL | EXPERIMENTAL | Cohort 2: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 |
| ESBA1008 0.6 mg/10 μL | EXPERIMENTAL | Cohort 3: One intravitreal injection on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 |
| ESBA1008 0.5 mg/8.3 μL | EXPERIMENTAL | Cohort 4: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 |
| Ranibizumab 0.5 mg in 50 μL | ACTIVE_COMPARATOR | Cohorts 1-4: One intravitreal injection on Day 0, followed by another intravitreal injection on Day 28 |
| ESBA1008 | EXPERIMENTAL | ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol |
| EYLEA | ACTIVE_COMPARATOR | Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol |
| LUCENTIS | ACTIVE_COMPARATOR | Ranibizumab 0.5 mg, single intravitreal injection |
| Name | Type | Description |
|---|---|---|
| ESBA1008 solution | DRUG | Intravitreal injection or infusion |
| Ranibizumab | DRUG | Intravitreal injection |
| Aflibercept | DRUG | For intravitreal (IVT) injection |
| Ranibizumab 0.5 mg | BIOLOGICAL | Administered as a single intravitreal injection |
Inclusion Criteria: * Sign informed consent document; * Able to make the required study visits and follow instructions; * Age-related macular degeneration in the study eye; * Visual acuity within protocol-specified range; * 340 μm minimal central subfield thickness (CSFT; Spectralis Equivalent) * O...
ESBA1008 is an investigational monoclonal antibody being developed for exudative age-related macular degeneration (wet AMD), a condition that causes vision loss due to abnormal blood vessel growth in the eye. It is administered as an intravitreal injection and is currently in clinical development, though it has not been approved by regulatory authorities.
ESBA1008 is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is a global medical device and pharmaceutical company focused on eye care, and it is conducting clinical trials to evaluate ESBA1008 for the treatment of wet age-related macular degeneration.
ESBA1008 is in Phase 2 clinical development. It has completed three clinical trials, including a Phase 1 safety study and two Phase 2 efficacy and safety studies. The drug remains investigational and has not received FDA approval, as it is still being evaluated for safety and effectiveness in patients with wet AMD.
ESBA1008 has completed three clinical trials: NCT01304693, a Phase 1 safety and tolerability study in wet AMD patients; NCT01796964, a Phase 2 study comparing ESBA1008 to EYLEA (aflibercept); and NCT01849692, a Phase 2 microvolume study. All trials were completed and enrolled a total of 656 patients.
No, ESBA1008 is not the same as EYLEA. ESBA1008 is an investigational monoclonal antibody developed by Alcon, while EYLEA (aflibercept) is an approved treatment for wet AMD. In a Phase 2 clinical trial (NCT01796964), ESBA1008 was directly compared to EYLEA to evaluate its efficacy and safety.
ESBA1008 is a monoclonal antibody designed to target and neutralize a specific protein involved in the development of abnormal blood vessels in the eye, which is a key driver of wet age-related macular degeneration. By blocking this target, ESBA1008 aims to reduce vascular leakage and prevent vision loss in affected patients.