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Lampalizumab · 1 trial · 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. |
| 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 |
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 |
| 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 |
Lampalizumab is an investigational small molecule being developed for the treatment of Geographic Atrophy, an advanced form of age-related macular degeneration that causes progressive vision loss. It is administered as an intravitreal injection. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Lampalizumab is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the safety and efficacy of Lampalizumab for the treatment of Geographic Atrophy.
Lampalizumab is in Phase 2 clinical development. A Phase 2 study has been completed, but the drug remains investigational and has not received regulatory approval. The completed trial enrolled 96 participants with Geographic Atrophy and was conducted in the United States.
Lampalizumab has one completed clinical trial registered under NCT02288559. This Phase 2 study evaluated intravitreal injections of Lampalizumab administered every two weeks or every four weeks in participants with Geographic Atrophy. The trial enrolled 96 participants, was sham-controlled, and was conducted in the United States.
No, Lampalizumab is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Geographic Atrophy. The completed Phase 2 trial (NCT02288559) has finished, but the drug has not yet received marketing authorization from the FDA or any other regulatory body.