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Also known as Lampalizumab
FCFD4514S · 3 trials · 1 indication
GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.
| Arm | Type | Description |
|---|---|---|
| Lampalizumab: Open-label Safety Run-In | EXPERIMENTAL | Participants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period. |
| Q2W Lampalizumab: Randomized Treatment | EXPERIMENTAL | Participants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period. |
| Q4W Lampalizumab: Randomized Treatment | EXPERIMENTAL | Participants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period. |
| Sham: Randomized Treatment | SHAM_COMPARATOR | Participants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab. |
| FCFD4514S | EXPERIMENTAL | - |
| sham | SHAM_COMPARATOR | - |
| A | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Sham | OTHER | Sham injection will be administered as a matching intravitreal injection of lampalizumab. |
| Lampalizumab | DRUG | 10 mg dose of lampalizumab administered intravitreally |
| FCFD4514S | DRUG | Repeating intravitreal injection |
Inclusion Criteria: * Complement Factor I (CFI) profile biomarker-positive result * Women of child bearing potential and men should remain abstinent or use contraceptive methods Exclusion Criteria: * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in stud...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Annexon, Inc. | ANNX | 2 | PHASE3 | Vonaprument (ANX007) |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Genentech, Inc. | RHHBY | 1 | PHASE2 | OpRegen |
| 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.