Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FCFD4514S · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| FCFD4514S | EXPERIMENTAL | - |
| sham | SHAM_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| FCFD4514S | DRUG | Repeating intravitreal injection |
| sham | DRUG | Repeating sham injection |
Inclusion Criteria: * Willingness and ability to provide signed Informed Consent; in addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws * Well-demarcated area of GA secondary to age-related...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628, SYFOVRE |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597, Sham Comparator |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
FCFD4514S is an investigational small molecule being developed for geographic atrophy, a form of age-related macular degeneration that causes progressive vision loss. It is administered by intravitreal injection directly into the eye. The drug is currently in clinical development and has not been approved by regulatory authorities.
FCFD4514S is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded over-the-counter under the ticker symbol RHHBY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for geographic atrophy.
FCFD4514S is in Phase 2 clinical development. It has completed a Phase 1 study and a Phase 2 study, both of which are finished. The drug remains investigational and has not received FDA approval. Its development status reflects ongoing research into its potential as a treatment for geographic atrophy.
FCFD4514S has been studied in two completed clinical trials. NCT00973011 was a Phase 1 study with 18 participants evaluating safety, tolerability, pharmacokinetics, and immunogenicity. NCT01229215 was a Phase 2 study with 143 participants testing monthly or every-other-month dosing. Both trials involved patients with geographic atrophy.
FCFD4514S is administered via intravitreal injection, meaning it is injected directly into the vitreous humor of the eye. This route of administration delivers the drug locally to the retina, where geographic atrophy occurs. The Phase 2 trial evaluated dosing schedules of monthly or every other month injections.