Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RFB002 · 1 trial · 2 indications
Visual acuity (VA) was assessed on the study eye during every study visit using best correction determined from protocol refraction. VA measurements were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.
| Arm | Type | Description |
|---|---|---|
| RFB002 | EXPERIMENTAL | RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved. |
| Laser photocoagulation | ACTIVE_COMPARATOR | At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4. |
| Name | Type | Description |
|---|---|---|
| RFB002 | DRUG | 0.5 mg |
| Laser photocoagulation | PROCEDURE | - |
Inclusion Criteria: 1. Diabetes mellitus 1 or 2, HbA1c \< 11.0%, With: Clinically significant Diabetic Macular Edema in at least one eye. 2. Previous treatment with macular photocoagulation only should be considered if the investigator believes that the study eye may possibly benefit from additiona...
| 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 |
RFB002 is an investigational small molecule being developed for diabetic macular edema, a condition that causes visual impairment due to fluid buildup in the macula of the eye. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
RFB002 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is in Phase 2 clinical development for diabetic macular edema.
RFB002 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. One Phase 2 clinical trial for the drug has been completed.
RFB002 has one completed clinical trial, identified as NCT00901186. This Phase 2 study evaluated the efficacy and safety of ranibizumab intravitreal injections versus laser treatment in patients with visual impairment due to diabetic macular edema. The trial enrolled 83 participants in Spain.
RFB002 is not the same as ranibizumab. The completed clinical trial NCT00901186 compared ranibizumab intravitreal injections against laser treatment in patients with diabetic macular edema. RFB002 is a separate investigational small molecule being developed by Novartis.