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FWY003 · 1 trial · 1 indication
To evaluate the dose response relationship of FWY003 on GA lesion area in the study eye in participants with GA secondary to age-related macular degeneration (AMD).
| Arm | Type | Description |
|---|---|---|
| FWY003 dose level 1 | EXPERIMENTAL | Participants will receive FWY003 dose level 1 |
| FWY003 dose level 2 | EXPERIMENTAL | Participants will receive FWY003 dose level 2 |
| FWY003 dose level 3 | EXPERIMENTAL | Participants will receive FWY003 dose level 3 |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo |
| Name | Type | Description |
|---|---|---|
| FWY003 | DRUG | FWY003 arm participants will receive a specific dose of FWY003 |
| Placebo | DRUG | Placebo arm participants will receive placebo |
Inclusion Criteria: Male or female participants ≥ 50 years of age. * A diagnosis of GA secondary to AMD in at least one eye (study eye). If both eyes qualify, then the eye with the better BCVA would be assigned as study eye. 1. Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), ...
FWY003 is an investigational small molecule being developed for geographic atrophy secondary to age-related macular degeneration, an advanced form of dry age-related macular degeneration that causes progressive vision loss. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
FWY003 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its potential to treat geographic atrophy secondary to age-related macular degeneration, a condition characterized by the degeneration of retinal pigment epithelial cells and photoreceptors.
FWY003 is being developed by Novartis AG, a global healthcare company headquartered in Basel, Switzerland. Novartis is listed on the New York Stock Exchange under the ticker symbol NVS.
FWY003 is currently in Phase 2 clinical development. It is being evaluated in a randomized, double-blind, placebo-controlled study to assess its efficacy and safety in participants with geographic atrophy secondary to age-related macular degeneration. The drug is investigational and not yet approved.
FWY003 is being studied in one active Phase 2 clinical trial with the identifier NCT07441642. This randomized, double-blind, placebo-controlled study is recruiting 272 participants across multiple countries, including the United States, Australia, Japan, and several European nations. The trial is currently in the recruiting stage.
FWY003 is a distinct investigational small molecule developed by Novartis for geographic atrophy secondary to age-related macular degeneration. It is not the same as approved complement inhibitors such as pegcetacoplan or avacincaptad pegol, which are administered via intravitreal injection. FWY003's mechanism of action has not been disclosed.