Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ESBA1008 solution, RTH258
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 being developed for the treatment of exudative age-related macular degeneration, also known as wet AMD. It is an investigational monoclonal antibody administered as an ophthalmic solution. All clinical testing to date has enrolled patients with this form of macular degeneration.
ESBA1008 is being developed by Alcon Inc., which trades under the ticker ALC. Alcon is an eye care company, and ESBA1008 is part of its ophthalmology pipeline. The program has completed three clinical trials in patients with exudative age-related macular degeneration.
ESBA1008 is in Phase 2 development. Three trials have been completed, including two Phase 2 studies and one Phase 1 study, with no trials currently active. It is an investigational therapy and has not been approved for commercial use.
ESBA1008 has been evaluated in three completed trials: NCT01849692, a Phase 2 microvolume study with 107 patients; NCT01796964, a Phase 2 efficacy and safety study versus EYLEA with 173 patients; and NCT01304693, a Phase 1 safety and tolerability study with 376 patients. All enrolled adults with exudative age-related macular degeneration.
Yes. ESBA1008 solution is another name for ESBA1008, the investigational monoclonal antibody being developed by Alcon Inc. for exudative age-related macular degeneration. Both names refer to the same ophthalmic product candidate.
The ESBA1008 trials were randomized, double-blind, and active-controlled, with a combined enrollment of 656 patients across three completed studies. Participants were adults aged 50 years and older with exudative age-related macular degeneration. One Phase 2 trial compared ESBA1008 directly against EYLEA.