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OpRegen · 2 trials · 2 indications
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. The AE's were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0.
| Arm | Type | Description |
|---|---|---|
| OpRegen | EXPERIMENTAL | OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space. |
| Name | Type | Description |
|---|---|---|
| OpRegen | BIOLOGICAL | OpRegen dose of up to approximately 200,000 cells will be delivered into the subretinal space. |
Inclusion Criteria: * Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care * Diagnosis of GA secondary to AMD * Best corrected visual acuity (BCVA) score ≥ 29 letters and ≤ 60 letters in the study eye as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS)...
| 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 |
OpRegen is an investigational cell therapy being developed for age-related macular degeneration and geographic atrophy, a late-stage form of the disease. It is delivered by subretinal injection and is currently in clinical trials for patients aged 50 years and older with these conditions.
OpRegen is being developed by Roche Holding AG, which trades over the counter under the ticker RHHBY. The company is conducting clinical trials of OpRegen in the United States and Israel for geographic atrophy secondary to age-related macular degeneration.
OpRegen is in clinical development. One trial is in Phase 1 and another is in Phase 2. Both are ongoing, with the Phase 2 study actively recruiting participants. OpRegen is not approved by the FDA and remains investigational.
OpRegen is being studied in two trials. NCT02286089 is a Phase 1 safety and efficacy study in advanced dry-form age-related macular degeneration, with 24 participants. NCT05626114 is a Phase 2 study in geographic atrophy secondary to age-related macular degeneration, with 60 participants, and includes an adaptive optics retinal imaging substudy.
No, OpRegen is not a monoclonal antibody. It is a cell therapy administered by subretinal injection. It is being evaluated for its safety and activity in treating geographic atrophy, a form of age-related macular degeneration.
OpRegen is associated with the GAlette study, which is the title of a Phase 2 clinical trial evaluating OpRegen in participants with geographic atrophy secondary to age-related macular degeneration. GAlette is the study name, not an alternative name for the drug itself.