Approval Probability
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Adjusted LOA
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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...
Top 16 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| 4D Molecular Therapeutics, Inc. | FDMT | 2 | PHASE3 | 4D-150, EYELEA |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE3 | Aflibercept |
| Hoffmann-La Roche | RHHBY | 6 | PHASE3 | Ranibizumab, Susvimo, RO7497372, RO7823653, Faricimab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | MK-8748 |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | Surabgene Lomparvovec |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tabirafusp tedromer |
| Alvotech | ALVO | 1 | PHASE3 | AVT29 |
| Kiora Pharmaceuticals, Inc. | KPRX | 1 | PHASE2 | KIO-104 |
| REGENXBIO, Inc. | RGNX | 1 | PHASE2 | RGX-314 |
| BioAge Labs, Inc. | BIOA | 1 | PHASE2 | BGE-102 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU200 |
| Surrozen Inc | SRZN | 1 | PHASE1 | SZN-8141 |
| Adverum Biotechnologies, Inc. | ADVM | 1 | - | ADVM-022 |
| Bayer | BAYRY | 1 | - | Aflibercept |
REGN910-3 is an investigational small molecule being developed by Regeneron Pharmaceuticals for retinal diseases. It is designed to target Ang2, a protein involved in blood vessel formation and vascular stability. Regeneron has studied it in diabetic macular edema and neovascular age-related macular degeneration, two leading causes of vision loss in adults.
REGN910-3 has been studied as an intravitreal treatment for diabetic macular edema and neovascular age-related macular degeneration. Both conditions involve abnormal blood vessel growth and leakage in the retina. The clinical program evaluated REGN910-3 in these two ophthalmology indications, with the goal of addressing the vascular abnormalities that drive fluid accumulation and vision loss.
REGN910-3 targets Ang2, also known as angiopoietin-2, a protein that regulates blood vessel stability and sprouting. By binding Ang2, the small molecule is intended to influence vascular biology in the retina. Ang2 is a distinct target from vascular endothelial growth factor, which is the focus of many existing ophthalmic therapies.
Regeneron Pharmaceuticals, Inc. is developing REGN910-3. Regeneron trades on the Nasdaq under the ticker REGN. The company has advanced the asset through Phase 1 and Phase 2 clinical testing in ophthalmology indications, including diabetic macular edema and neovascular age-related macular degeneration.
REGN910-3 has completed Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA for any indication. Regeneron has conducted two completed Phase 2 trials and one completed Phase 1 trial, with no active trials currently listed for the program.
REGN910-3 has been evaluated in three completed trials. NCT02713204 was a Phase 2 study in neovascular age-related macular degeneration with 365 patients. NCT02712008 was a Phase 2 study in diabetic macular edema with 302 patients. NCT01997164 was a Phase 1 study in both conditions with 20 patients.