Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04674800 | Extension Study of MYL-1701P-3001 for Safety and Efficacy | PHASE3 | COMPLETED | 52 | — | — | Nov 23, 2020 | Apr 20, 2022 | Aug 26, 2022 | 15 | India |
| NCT03610646 | Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME) | PHASE3 | COMPLETED | 355 | — | — | Aug 23, 2018 | Sep 10, 2021 | Mar 7, 2023 | 73 | United States, Czechia +7 |
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 |