Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VIS-101 6.0mg High concentration
VIS-101 High concentration · 1 trial · 1 indication
BCVA as measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The ETDRS letter score ranges from 0 to 100, with a higher score indicating better visual acuity
| Arm | Type | Description |
|---|---|---|
| VIS-101 6.0mg Low concentration | EXPERIMENTAL | VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol. |
| VIS-101 6.0mg High concentration | EXPERIMENTAL | VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol. |
| VIS-101 9.0mg High concentration | EXPERIMENTAL | VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol. |
| Aflibercept | ACTIVE_COMPARATOR | Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W). |
| Name | Type | Description |
|---|---|---|
| VIS-101 6.0mg High concentration | BIOLOGICAL | VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol. |
| VIS-101 9.0mg High concentration | BIOLOGICAL | VIS-101 will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol. |
| Aflibercept (Eylea) | BIOLOGICAL | Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W). |
Inclusion Criteria: 1. Willingness to sign the informed consent form, aged ≥50 years (on Day 0 of dosing), with no gender restrictions 2. Able to adhere to the study protocol per the Investigator judgment 3. Female participants of childbearing potential (WOCBP) or male participants with partners wh...