Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication EYLEA is indicated for the treatment of: EYLEA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.2 ) Diabetic Macular Edema (DME) ( 1.3 ) Diabetic Retinopathy (DR) ( 1.4 ) Retinopathy of Prematurity (ROP) ( 1.5 ) 1.1 Neovascular (Wet)… FDA label
Also known as Eylea, Aflibercept
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 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
IVT Aflibercept is being studied for diabetic macular edema, a complication of diabetes in which fluid accumulates in the macula and impairs vision. Clearside Biomedical developed it as part of a suprachoroidal delivery program combining intravitreal aflibercept with suprachoroidal CLS-TA. It remains an investigational approach in clinical development.
IVT Aflibercept is being developed by Clearside Biomedical, Inc., which trades under the ticker CLSD. The company sponsored the clinical program evaluating intravitreal aflibercept given with suprachoroidal CLS-TA in patients with diabetic macular edema, conducted at sites in the United States.
IVT Aflibercept has been studied in Phase 2 clinical development for diabetic macular edema. Both of its recorded trials are completed, and no trials are currently active. It is an investigational therapy and is not described as FDA approved for this use.
IVT Aflibercept has been evaluated in two completed trials in diabetic macular edema. NCT03126786 was a Phase 2 study of suprachoroidal CLS-TA with intravitreal aflibercept versus aflibercept alone, enrolling 71 patients. NCT02949024 was a Phase 1/Phase 2 study of suprachoroidal CLS-TA alone or with aflibercept, enrolling 20 patients.
Both IVT Aflibercept trials were randomized, double-blind studies in adults with diabetic macular edema, conducted in the United States. NCT03126786 used an active-controlled design comparing suprachoroidal CLS-TA plus intravitreal aflibercept against aflibercept alone. Together the two completed studies enrolled 91 participants.