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PDS Pre-Filled with/mL Ranibizumab · 2 trials · 2 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. |
| 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. |
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...
| 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 |
PDS Pre-Filled with/mL Ranibizumab is an investigational ophthalmology treatment being studied for diabetic retinopathy and diabetic macular edema. It is a Port Delivery System pre-filled with 100 mg/mL ranibizumab, designed to deliver the medication continuously. The drug is in Phase 3 clinical development and is not yet approved.
PDS Pre-Filled with/mL Ranibizumab contains ranibizumab, which targets vascular endothelial growth factor A (VEGF-A). By inhibiting VEGF-A, ranibizumab aims to reduce abnormal blood vessel growth and leakage in the retina, which are central to diabetic retinopathy and diabetic macular edema.
PDS Pre-Filled with/mL Ranibizumab is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. Roche is conducting Phase 3 clinical trials to evaluate the efficacy, safety, and pharmacokinetics of this Port Delivery System with ranibizumab in patients with diabetic eye conditions.
PDS Pre-Filled with/mL Ranibizumab is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 3 trials have been conducted: one active but not recruiting and one completed, both evaluating the treatment in patients with diabetic retinopathy or diabetic macular edema.
PDS Pre-Filled with/mL Ranibizumab is being studied in two Phase 3 trials. NCT04108156, with 672 participants, evaluates the Port Delivery System with ranibizumab versus intravitreal ranibizumab in diabetic macular edema and is active but not recruiting. NCT04503551, with 174 participants, studies the treatment in diabetic retinopathy without center-involved diabetic macular edema and is completed.
Yes, PDS Pre-Filled with/mL Ranibizumab is also known as PDS Implant Pre-Filled with 100 mg/mL Ranibizumab. Both names refer to the same Port Delivery System implant pre-filled with ranibizumab at a concentration of 100 mg/mL, developed by Roche for treating diabetic retinopathy and diabetic macular edema.