Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as bevacizumab
ONS-5010 · 5 trials · 5 indications
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
Number of participants with adverse events
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
| Arm | Type | Description |
|---|---|---|
| ONS-5010 bevacizumab | EXPERIMENTAL | - |
| ranibizumab | ACTIVE_COMPARATOR | - |
| Biological: bevacizumab | EXPERIMENTAL | - |
| bevacizumab | EXPERIMENTAL | ONS-5010 |
| Name | Type | Description |
|---|---|---|
| bevacizumab | BIOLOGICAL | 1.25 mg, intravitreal injection |
| ranibizumab | BIOLOGICAL | 0.5mg, intravitreal injection |
Inclusion Criteria: * Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye * Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 Snellen equivalent) * Study eye must: * Have active leakage on Fluorescein A...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 7 | PHASE3 | Surabgene Lomparvovec, RGX-314, ABBV-6628 |
| Ocular Therapeutix Inc | OCUL | 3 | PHASE3 | OTX-TKI |
| 4D Molecular Therapeutics, Inc. | FDMT | 3 | PHASE3 | 4D-150 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Aflibercept, Pozelimab, Cemdisiran |
| Novartis AG Sponsored ADR | NVS | 5 | PHASE2 | Iptacopan, GT005, FWY003 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Hoffmann-La Roche | RHHBY | 10 | PHASE3 | Ranibizumab, Susvimo, RO7965032, OpRegen, Faricimab |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Adverum Biotechnologies, Inc. | ADVM | 4 | PHASE3 | Ixo-vec, ADVM-022 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-3007 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 938, Aflibercept |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Ocugen Inc | OCGN | 1 | PHASE3 | OCU410 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-033 |
| Bayer | BAYRY | 2 | - | Aflibercept |
ONS-5010 is an investigational ophthalmic formulation being developed for the treatment of neovascular age-related macular degeneration, also called wet AMD. It is also being studied in patients with visual impairment due to retinal disorders, including branch retinal vein occlusion and diabetic macular edema.
ONS-5010 targets VEGFA, vascular endothelial growth factor A. It is a monoclonal antibody that acts as an inhibitor of VEGFA. By binding VEGFA, the drug is designed to block the signaling that drives abnormal blood vessel growth and leakage in the retina.
ONS-5010 is being developed by Outlook Therapeutics, Inc., which trades under the ticker OTLK. The company is advancing the asset as an ophthalmic monoclonal antibody formulation for retinal disease.
ONS-5010 is in Phase 3 clinical development. It is an investigational product and has not been established as approved. Four Phase 3 trials have been conducted or are ongoing, with three completed and one active but no longer recruiting.
ONS-5010 has been studied in four Phase 3 trials: NCT06190093 in neovascular AMD, NCT05112861 comparing vial versus pre-filled syringe safety, NCT04516278 assessing safety in retinal disorders, and NCT03844074 examining efficacy and safety in neovascular AMD. Total enrollment across these trials is 606 participants.
Yes, ONS-5010 is also known as bevacizumab. It is an ophthalmic formulation of the monoclonal antibody bevacizumab, developed by Outlook Therapeutics for retinal indications rather than the intravenous oncology uses associated with the same molecule.