Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IVT Aflibercept · 2 trials · 1 indication
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up
| Arm | Type | Description |
|---|---|---|
| Active | ACTIVE_COMPARATOR | Treatment will consist of IVT injection of Aflibercept followed by an SC injection of CLS-TA |
| Control | SHAM_COMPARATOR | Treatment will consist of IVT aflibercept injection followed by a sham SC procedure |
| TX Naïve Arm | EXPERIMENTAL | Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye. |
| Previous TX Arm | EXPERIMENTAL | Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA. |
| Name | Type | Description |
|---|---|---|
| IVT aflibercept | DRUG | IVT aflibercept \[2 mg/0.05 mL\] |
| Sham SC | DRUG | sham SC |
| SC CLS-TA | DRUG | CLS-TA \[4 mg/100 μL\] SC injection |
Inclusion Criteria: * Clinical diagnosis of type 1 or type 2 DM * DME with central involvement (\> 300 µm in the central subfield on spectral-domain optical coherence tomography \[SD-OCT\], in the study eye * ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye * Naïve to lo...
| 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 |
IVT Aflibercept is an investigational small molecule being studied for the treatment of Diabetic Macular Edema. It is administered via suprachoroidal injection, either alone or in combination with intravitreal aflibercept, to evaluate its safety and efficacy in patients with this condition.
IVT Aflibercept is being developed by Clearside Biomedical, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLSD. The company is conducting clinical trials to assess the drug's potential in treating Diabetic Macular Edema.
IVT Aflibercept is in Phase 2 clinical development. It has completed two trials, including a Phase 1 study and a Phase 2 study, both of which have been completed. The drug remains investigational and is not yet approved for commercial use.
IVT Aflibercept has been studied in two completed clinical trials. NCT02949024 was a Phase 1 study with 20 participants, and NCT03126786 was a Phase 2 study with 71 participants. Both trials were conducted in the United States and focused on Diabetic Macular Edema.
IVT Aflibercept is administered via suprachoroidal injection, as studied in clinical trials. In the Phase 2 trial, it was given in combination with intravitreal aflibercept and compared to aflibercept alone. The trials were randomized, double-blind, and controlled.