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Also known as MYL-1701P
MYL-1701P, a proposed biosimilar to Eylea · 2 trials · 1 indication
Number of participants with TEAEs
Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8. Best Corrected Visual Acuity (BCVA) is measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the ETDRS chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
| Arm | Type | Description |
|---|---|---|
| Single, test arm | EXPERIMENTAL | MYL-1701P- Subjects will receive 3 doses each of 2 mg at 8 weeks interval |
| MYL-1701P | EXPERIMENTAL | MYL-1701P |
| Eylea | ACTIVE_COMPARATOR | Eylea |
| Name | Type | Description |
|---|---|---|
| MYL-1701P, a proposed biosimilar to Eylea | BIOLOGICAL | Open label and single arm |
| MYL-1701P | DRUG | Subjects will receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol. |
| Eylea | DRUG | Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks. The additional doses may be administered in accordance with the protocol. |
Inclusion Criteria: 1. Subject participated in the MYL-1701P-3001 study 2. Subject requires treatment with intravitreal anti-VEGF therapy 3. Subject is able to understand and voluntarily provide written informed consent to participate in the study. 4. If female of childbearing potential, the subjec...
Top 10 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-150 |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
MYL-1701P is a proposed biosimilar to Eylea, also known as aflibercept, developed by Viatris Inc. (ticker: VTRS). It is a monoclonal antibody being studied for the treatment of diabetic macular edema. The program has completed two Phase 3 clinical trials.
MYL-1701P is being developed as a treatment for diabetic macular edema (DME), a complication of diabetes that can cause vision loss. It is intended as a biosimilar to Eylea, meaning it is designed to be highly similar to the reference product. It is not yet approved.
MYL-1701P is being developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the sponsor of the clinical development program for this proposed biosimilar to Eylea.
MYL-1701P is in Phase 3 clinical development. Two Phase 3 trials have been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
MYL-1701P has been studied in two completed Phase 3 trials: NCT03610646, a comparative study of MYL-1701P and Eylea in diabetic macular edema with 355 participants, and NCT04674800, an extension study with 52 participants. Both trials are completed.
No, MYL-1701P is not the same as Eylea. MYL-1701P is a proposed biosimilar to Eylea, meaning it is developed to be highly similar to the reference product but is a separate investigational agent. Eylea is the brand name for aflibercept.