Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
6E11 vg/eye of ADVM-022 · 1 trial · 2 indications
Time to worsening of DME disease activity in the study eye through 96 weeks. Time to worsening of DME disease activity defined by either: An increase in CST \> 50 µm as assessed by SD-OCT compared to the lower of the two CST measurements recorded at Day 1 or Week 4; A loss of \> 5 letters in BCVA due to worsening DME disease activity compared to the higher of the two BCVA measurements recorded at Day 1 or Week 4. Number of weeks was relative to Day 1.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 6E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT |
| 2 | EXPERIMENTAL | 2E11 vg/eye ADVM-022 +/- aflibercept 2mg IVT |
| 3 | ACTIVE_COMPARATOR | Aflibercept 2mg IVT |
| Name | Type | Description |
|---|---|---|
| 6E11 vg/eye of ADVM-022 | BIOLOGICAL | ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept |
| 2E11 vg/eye of ADVM-022 | BIOLOGICAL | ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-incompetent adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept |
| Aflibercept | BIOLOGICAL | Commercially available Active Comparator |
Inclusion Criteria: * Age ≥ 18 * Type 1 or Type 2 diabetes mellitus * Willing and able to provide informed consent * Vision impairment due to center involving diabetic macular edema Exclusion Criteria: * Uncontrolled diabetes defined as HbA1C \>10%, or history of diabetic ketoacidosis within 3 mo...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901, Aflibercept |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Oculis Holding AG | OCS | 2 | PHASE3 | Dexamethasone, Vehicle |
| AbbVie, Inc. | ABBV | 3 | PHASE2 | ABBV-RGX-314 Dose 1, Steroid, Aflibercept |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | bevacizumab |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 IVT, Aflibercept IVT |
| Alvotech | ALVO | 1 | PHASE3 | AVT29, Eylea HD |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 Dose 1, RGX-314 Dose 2, Aflibercept |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
6E11 vg/eye of ADVM-022 is an investigational gene therapy being studied for the treatment of Diabetic Macular Edema (DME). It is administered via intravitreal injection and is currently in Phase 2 clinical development. The therapy is designed to address the underlying causes of DME, a condition that can lead to vision loss.
6E11 vg/eye of ADVM-022 is being developed by Adverum Biotechnologies, Inc., a biopharmaceutical company. Adverum Biotechnologies is publicly traded under the ticker symbol ADVM. The company is focused on developing gene therapies for serious diseases, including those affecting the eye.
6E11 vg/eye of ADVM-022 is in Phase 2 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The Phase 2 trial has been completed, and the therapy is being evaluated for its safety and efficacy in patients with Diabetic Macular Edema.
6E11 vg/eye of ADVM-022 has been studied in one clinical trial, identified as NCT04418427. This Phase 2 trial, titled 'ADVM-022 Intravitreal Gene Therapy for DME,' was completed and enrolled 36 participants with Diabetic Macular Edema and Diabetic Retinopathy. The trial was conducted in the United States and Puerto Rico.
Yes, 6E11 vg/eye of ADVM-022 is a specific dose of the gene therapy ADVM-022. The '6E11 vg/eye' designation refers to the dose of the therapy administered, which is 6 x 10^11 vector genomes per eye. ADVM-022 is the investigational gene therapy being developed by Adverum Biotechnologies for Diabetic Macular Edema.