Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| 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 |
MYL-1701P is an investigational proposed biosimilar to Eylea being developed for the treatment of Diabetic Macular Edema (DME). It is a monoclonal antibody administered in ophthalmology. The drug is currently in Phase 3 clinical development and has completed two trials, including a comparative study against Eylea in patients with DME.
MYL-1701P is a proposed biosimilar to Eylea, which targets vascular endothelial growth factor (VEGF). As a monoclonal antibody, it is designed to bind to VEGF and inhibit its activity, which is involved in the pathogenesis of Diabetic Macular Edema. The drug is being studied for its efficacy and safety in treating this condition.
MYL-1701P is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. Viatris is conducting Phase 3 clinical trials to evaluate the proposed biosimilar for the treatment of Diabetic Macular Edema.
MYL-1701P is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, including a comparative study against Eylea and an extension study, with a total enrollment of 407 patients.
MYL-1701P has completed two Phase 3 trials. The first, NCT03610646, compared MYL-1701P to Eylea in 355 patients with Diabetic Macular Edema across multiple countries. The second, NCT04674800, was an extension study in 52 patients in India. Both trials were randomized, double-blind, and active-controlled.
MYL-1701P is a proposed biosimilar to Eylea, meaning it is designed to be highly similar to the reference product Eylea in terms of safety, efficacy, and quality. However, it is not the same as Eylea; it is an investigational product being developed by Viatris to potentially serve as a more affordable alternative.