Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN910-3 · 3 trials · 2 indications
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Best Corrected Visual Acuity (BCVA) score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 36.
Incidence of TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910 TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910
| Arm | Type | Description |
|---|---|---|
| REGN910-3 (3 mg: 2 mg) | EXPERIMENTAL | Participants were administered intravitreal injection of REGN910-3 (3 milligram \[mg\]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32. |
| REGN910-3 (6 mg:2 mg) | EXPERIMENTAL | Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32. |
| Aflibercept (IAI) 2 mg | EXPERIMENTAL | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32. |
| Aflibercept 2 mg | ACTIVE_COMPARATOR | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. |
| REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8 | EXPERIMENTAL | Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at Week 16 and Q8 through Week 32. |
| REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12 | EXPERIMENTAL | Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at Week 20 and Q12 through Week 32. |
| Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8 | EXPERIMENTAL | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI at Week16 and Q8 through Week 32. |
| Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12 | EXPERIMENTAL | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI at Week 20 and Q12 through Week 32. |
| Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8 | EXPERIMENTAL | Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at week 16 and Q8 through week 32. |
| Cohorts 1 through 4 | EXPERIMENTAL | Participants in cohorts 1 through 4 will receive IVT REGN910-3 and IAI |
| Cohort 5 | EXPERIMENTAL | Participants in cohort 5 will receive IVT REGN910 and IAI |
| Name | Type | Description |
|---|---|---|
| REGN910-3 | DRUG | - |
| Intravitreal Aflibercept Injection (IAI) | DRUG | - |
| REGN910 | DRUG | - |
Key Inclusion Criteria: 1. Men or women ≥50 years of age with active subfoveal CNV secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye as assessed by a central reading center 2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to...
| 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 |
REGN910-3 is an investigational small molecule being developed for neovascular (wet) age-related macular degeneration and diabetic macular edema. It is administered as an intravitreal injection and has been studied in patients with these retinal conditions.
REGN910-3 is being developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker symbol REGN on the NASDAQ. The company has conducted clinical trials of this investigational therapy in the United States.
REGN910-3 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and is not FDA approved. The completed trials evaluated the therapy in patients with neovascular age-related macular degeneration and diabetic macular edema.
REGN910-3 has been studied in three completed trials: NCT01997164, a Phase 1 study in wet AMD and diabetic macular edema; NCT02712008, a Phase 2 study in diabetic macular edema; and NCT02713204, a Phase 2 study in neovascular AMD. Total enrollment across these trials was 385 patients.
REGN910-3 is designed to target both vascular endothelial growth factor and angiopoietin 2, as indicated by the trial titles. This dual mechanism aims to address retinal diseases by inhibiting these pathways involved in abnormal blood vessel growth and leakage.