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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 |
| 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 |
OpRegen is an investigational cell therapy being studied for geographic atrophy and age-related macular degeneration, advanced dry-form conditions that cause progressive vision loss. It is delivered subretinally and is currently in clinical development, not yet approved by the FDA.
OpRegen is being developed by Roche Holding AG, traded over the counter as RHHBY. The company is conducting clinical trials to evaluate the safety and activity of OpRegen in patients with geographic atrophy and age-related macular degeneration.
OpRegen is in Phase 1 and Phase 2 clinical trials. The Phase 1 study (NCT02286089) is active but not recruiting, while the Phase 2 study (NCT05626114) is currently recruiting participants. It remains investigational and has not received FDA approval.
OpRegen is being studied in two trials. NCT02286089 is a Phase 1 safety and efficacy study for advanced dry-form age-related macular degeneration. NCT05626114 is a Phase 2 study optimizing subretinal surgical delivery and evaluating safety and activity in geographic atrophy, including an adaptive optics retinal imaging substudy.
OpRegen is administered via subretinal injection, a surgical delivery method. The Phase 2 trial (NCT05626114) specifically aims to optimize this subretinal surgical delivery technique in participants with geographic atrophy secondary to age-related macular degeneration.
OpRegen is a distinct investigational cell therapy for geographic atrophy and age-related macular degeneration. No alternative names have been reported for this asset in the clinical trial information available.