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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 by Novartis AG for geographic atrophy secondary to age-related macular degeneration, an ophthalmology condition. It is currently in Phase 2 clinical development and has not been approved by the FDA. The program includes one active trial with a planned enrollment of 272 participants.
FWY003 is being studied for the treatment of geographic atrophy secondary to age-related macular degeneration. Geographic atrophy is an advanced form of age-related macular degeneration that involves progressive loss of retinal tissue. FWY003 is investigational and is not approved for this or any other indication.
FWY003 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the Phase 2 clinical program evaluating FWY003 in geographic atrophy secondary to age-related macular degeneration.
FWY003 is in Phase 2 clinical development. The single registered trial for FWY003 is a Phase 2 study, and it is currently recruiting participants. FWY003 has not completed any trials and is not FDA approved; it remains an investigational agent.
FWY003 is being evaluated in the Phase 2 trial NCT07441642, titled a study to investigate efficacy and safety of FWY003 compared with placebo in participants with geographic atrophy secondary to age-related macular degeneration. The trial is recruiting, is randomized, double blind, and placebo controlled, and plans to enroll 272 participants across 18 countries.
The Phase 2 trial NCT07441642 enrolls participants aged 50 years and older of any sex. It does not accept healthy volunteers, since participants must have geographic atrophy secondary to age-related macular degeneration. The study is recruiting across the United States, Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Czechia, France, Germany, Hungary, Italy, Japan, Poland, Puerto Rico, Romania, Spain, and the United Kingdom.