Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MHU650 · 1 trial · 4 indications
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Best Correct Visual Acuity was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Central subfield thickness was measured by spectral domain optical coherence tomography (SD-OCT).
Intraocular pressure was measured per the sites' local standard operating procedures, via tonometry.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1; open-label, non-randomized, single administration |
| Cohort 2 | EXPERIMENTAL | Cohort 2; open-label, non-randomized, single administration |
| Cohort 3 | EXPERIMENTAL | Cohort 3, open-label; non-randomized, single administration |
| Cohort 4 | EXPERIMENTAL | Cohort 4, open-label, non-randomized, single administration |
| Name | Type | Description |
|---|---|---|
| MHU650 | DRUG | MHU650 powder for solution for injection |
Key Inclusion Criteria: * Patients with macular edema in at least one eye, including those with focal or diffuse diabetic macular edema (DME), neovascular age-related macular degeneration (nAMD), or retinal vein occlusion (RVO). In the opinion of the investigator, the decrease in vision in the stud...
| 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 |
MHU650 is an investigational small molecule being developed for the treatment of macular edema, a condition involving fluid accumulation in the macula of the eye. It is being studied in patients with macular edema, including those with diabetic macular edema, neovascular age-related macular degeneration, and retinal vein occlusion.
MHU650 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the safety, tolerability, and pharmacokinetics of this investigational therapy.
MHU650 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study evaluating the drug has been completed, and it remains in early-stage clinical development for the treatment of macular edema.
MHU650 has one completed Phase 1 clinical trial, identified as NCT04635800. This study evaluated the safety, tolerability, and pharmacokinetics of intravitreal MHU650 in patients with macular edema, including those with diabetic macular edema, neovascular age-related macular degeneration, and retinal vein occlusion. The trial enrolled 21 participants.
MHU650 is administered via intravitreal injection, meaning it is injected directly into the vitreous humor of the eye. This route of administration is commonly used for ophthalmic therapies to deliver the drug directly to the site of disease in the retina.