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Label indication SUSVIMO (ranibizumab injection) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.1 ). Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.2 ). FDA label
Also known as Ranibizumab refill exchange
Susvimo · 3 trials · 3 indications
ETDRS-DRSS classifies diabetic retinopathy (DR) into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). DRSS grades= 10 (DR absent) - 85 (very advanced PDR), DRSS 90 = ungradable. All DRSS values are converted into a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR), allowing derivation of ≥2-step change from baseline for post-baseline assessment. A lower score represents less advanced diabetic retinopathy. The Cochran-Mantel Haenszel (CMH) method was used for analysis and weighted percentage of participants are estimated and reported in this outcome measure. Participants receiving supplemental treatments, prohibited therapy, or panretinal photocoagulation (PRP) were considered non-responders. Missing values not preceded by these intercurrent events were imputed using the last observation carried forward method. SD OCT= spectral-domain optical coherence tomography.
BCVA = Best-Corrected Visual Acuity ETDRS = Early Treatment Diabetic Retinopathy Study A vision score of 20/20 vision is considered normal. A score of 20/200 is considered being legally blind.
| Arm | Type | Description |
|---|---|---|
| PDS Arm | EXPERIMENTAL | Participants randomized to the PDS arm will receive two intravitreal ranibizumab injections and will then have the PDS implant (pre-filled with ranibizumab) surgically inserted. PDS implant refill-exchange procedures will be performed on a fixed interval every 36-weeks (Q36W) thereafter |
| Comparator Arm | OTHER | Participants randomized to the comparator arm will undergo study visits every 4 weeks (Q4W) for comprehensive clinical monitoring until they receive the PDS implant (pre-filled with ranibizumab). PDS implant refill-exchange procedures will be performed on a fixed interval Q36W thereafter. Participants will be eligible to receive intravitreal ranibizumab 0.5 mg injections if treatment eligibility criteria are met. |
| Intravitreal Arm | ACTIVE_COMPARATOR | Participants randomized to the intravitreal arm will receive IVT ranibizumab injection Q4W until they receive the PDS implant (pre-filled with ranibizumab). PDS implant refill-exchange procedures will be performed on a fixed interval Q24W thereafter. |
| Substudy: Cohort 1 | EXPERIMENTAL | Participants will undergo re-implantation with the updated PDS implant (pre-filled with ranibizumab 100 milligrams per milliliter \[mg/mL\]) on Day 1 (or enrollment visit) and then will have two refill-exchanges (ranibizumab 100 mg/mL) Q24W up to 48 weeks. |
| Substudy: Cohort 2a | EXPERIMENTAL | Participants who received an updated PDS implant, have \< 24 weeks post-re-implantation follow-up and no scheduled refill-exchange visit in the main study, will undergo two refill-exchange procedures (ranibizumab 100 mg/mL) Q24W, post main study re-implantation visit. |
| Substudy: Cohort 2b | EXPERIMENTAL | Participants who received an updated PDS implant, have \< 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, regardless of whether the refill exchange was administered or the visit was missed, will undergo one refill-exchange procedure (ranibizumab 100 mg/mL) Q24W, post main study re-implantation visit. |
| PDS Implant Cohort 1 (US only) | EXPERIMENTAL | Participants with PDS implant from Study GX28228 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240. Eligible participants from Study GX28228 will be enrolled upon completion of their final visit. |
| PDS Implant Cohort 2 (US only) | EXPERIMENTAL | Participants with PDS implant from Study GR40548 treated with refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240. Eligible participants from Study GR40548 will be enrolled upon completion of their final visit. |
| PDS Implant Cohort 3 (US only) | EXPERIMENTAL | Participants in the intravitreal ranibizumab arm of Study GX28228 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 168 to Week 240. Eligible participants from Study GX28228 will be enrolled upon completion of their final visit. |
| PDS Implant Cohort 4 (US only) | EXPERIMENTAL | Participants in the intravitreal ranibizumab arm of Study GR40548 who will receive the PDS implant upon study entry and refill-exchanges of 100 mg/mL ranibizumab Q24W. Participants will switch to an every 12 weeks (Q12W) visit schedule from Week 144 to Week 240. Eligible participants from Study GR40548 will be enrolled upon completion of their final visit. |
| PDS Implant Cohort 5 (ex-US only) | EXPERIMENTAL | Participants from Study WR42221 who completed Week 24 but were not eligible to be randomized within WR42221 and who will be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor. |
| PDS Implant Cohort 6 (ex-US only) | EXPERIMENTAL | Participants from Study WR42221 randomized to the Q24W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q24W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor. |
| PDS Implant Cohort 7 (ex-US only) | EXPERIMENTAL | Participants from Study WR42221 randomized to the Q36W arm, who will continue to be treated with refill-exchanges of ranibizumab 100 mg/mL Q36W. Participants will be in the study for a minimum of 144 weeks and may continue after Week 144 until the PDS has received Health Authority approval (or non-approval) in their respective country and/or until the decision to close the study has been made by the sponsor. |
| Sub-study 1: PDS Implant | EXPERIMENTAL | Participants will receive PDS implant using TPC on Day 1 followed by refill-exchanges of ranibizumab 100 mg/mL via the PDS Q24W. |
| Sub-study 2: Cohort 1 | EXPERIMENTAL | Participants will undergo re-implantation with the updated PDS implant and receive 2 refill-exchanges of ranibizumab 100 mg/mL Q24W. |
| Sub-study 2: Cohort 2a | EXPERIMENTAL | Participants who received an updated PDS implant, have \< 24 weeks post-re-implantation follow-up and no refill exchange visit in the main study, will undergo two refill-exchange procedures with ranibizumab 100 mg/mL Q24W post main study re-implantation visit. |
| Sub-study 2: Cohort 2b | EXPERIMENTAL | Participants who received an updated PDS implant, have \< 48 weeks post-re-implantation follow-up and one refill exchange visit in the main study, will undergo one refill-exchange procedure with ranibizumab 100 mg/mL Q24W post main study re-implantation visit. |
| Name | Type | Description |
|---|---|---|
| PDS Implant Pre-Filled with 100 mg/mL Ranibizumab | DRUG | Will be administered as per the schedule described in individual arm. |
| Intravitreal Ranibizumab 0.5 mg Injection | DRUG | Will be administered as per the schedule described in individual arm. |
| Ranibizumab refill exchange | DRUG | Will be administered as per the schedule described in individual arm. |
| PDS Implant with Ranibizumab 100 mg/mL | DRUG | Will be administered as per the schedule described in individual arm |
Inclusion Criteria: * Age ≥18 years at time of signing Informed Consent Form * Documented diagnosis of diabetes mellitus (Type 1 or Type 2) * HbA1c level of ≤12% within 2 months prior to screening or at screening Inclusion Criteria for Study Eye * Moderately severe or severe NPDR (ETDRS-DRSS leve...
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 |
Susvimo is an ocular implant that delivers ranibizumab continuously into the eye. It is being developed by Roche Holding AG (ticker RHHBY) for retinal conditions including neovascular age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The implant is a monoclonal antibody-based treatment administered through a refill exchange system.
Susvimo is used for the treatment of neovascular age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. It delivers ranibizumab directly into the eye via a port delivery system, offering an alternative to frequent intravitreal injections for these retinal conditions.
Susvimo targets VEGFA, vascular endothelial growth factor A. Ranibizumab, the active agent delivered by the implant, is a monoclonal antibody fragment that acts as a VEGFA inhibitor, binding and neutralizing VEGF-A to reduce abnormal blood vessel growth and leakage in the retina.
Susvimo is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the company behind the port delivery system and the ranibizumab formulation used in the implant.
Susvimo is in Phase 3 clinical development. It is an investigational therapy and has not been established as approved for the indications studied. The Phase 3 program includes trials in diabetic retinopathy, diabetic macular edema, and neovascular age-related macular degeneration.
Susvimo has been studied in Phase 3 trials including NCT04503551 in diabetic retinopathy, NCT04108156 in diabetic macular edema, and NCT03683251, an extension study in neovascular age-related macular degeneration. These trials are randomized and active-controlled, with enrollment ranging from 174 to 1,000 participants.