susvimo
Pharmaranks rates Susvimo 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Susvimo (Ranibizumab) is a vascular endothelial growth factor inhibitor used to treat Diabetic Retinopathy, Macular Edema, Retinal Vein Occlusion.
Ranibizumab · by Genentech Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ranibizumab
- Form
- Injectable
- Strength
- Ranibizumab 100MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Genentech Inc
- FDA application
- BLA761197
- FDA boxed warning
- Yes — see the boxed warning
What is Susvimo?
From the FDA label:Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor-A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product. SUSVIMO (ranibizumab injection) is supplied as a sterile, clear to slightly opalescent, colorless to slightly brownish solution for intravitreal use via the SUSVIMO implant. Each single-dose vial contains 10 mg of ranibizumab, histidine HCl (0.1 mg), polysorbate 20 (0.01 mg), sucrose (8.2 mg), and Water for Injection, in 0.1 mL of solution with a pH of 5.5. The SUSVIMO implant is designed to contain approximately 0.02 mL (2 mg) of ranibizumab solution when filled. SUSVIMO does not contain an antimicrobial preservative.
How to use
For intravitreal use via SUSVIMO ocular implant. ( 2.1 ) Neovascular (wet) Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) The recommended dose of SUSVIMO (ranibizumab injection) is 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the SUSVIMO implant with refills every 24 weeks (approximately 6 months). ( 2.2 ) Diabetic Retinopathy (DR) The recommended dose of SUSVIMO (ranibizumab injection) is 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the SUSVIMO implant with refills every 36 weeks (approximately 9 months). ( 2.3 ) Supplemental treatment with 0.5 mg intravitreal ranibizumab injection may be administered in the affected eye if clinically necessary. ( 2.4 ) Perform the initial implantation, refill-exchange, and implant removal (if necessary) procedures under strict aseptic conditions. ( 2.5 , 2.6 , 2.7 , 2.8 ) 2.1 General Information For Intravitreal Use via SUSVIMO ocular implant. The SUSVIMO initial fill and ocular implant insertion and implant removal procedures must be performed under aseptic conditions by a physician experienced in vitreoretinal surgery. The SUSVIMO ocular implant must be surgically implanted in the eye or removed from the eye (if medically necessary) in an operating room using aseptic technique. See SUSVIMO Instructions for Use and the standardized steps to optimize surgical outcomes. SUSVIMO…
Side effects
The following adverse reactions are discussed in greater detail in other sections of the label: Endophthalmitis [see Warnings and Precautions (5.1) ] Rhegmatogenous Retinal Detachment [see Warnings and Precautions (5.2) ] Implant Dislocation [see Warnings and Precautions (5.3) ] Septum Dislodgement [see Warnings and Precautions (5.4) ] Vitreous Hemorrhage [see Warnings and Precautions (5.5) ] Conjunctival Erosion or Retraction [see Warnings and Precautions (5.6) ] Conjunctival Bleb [see Warnings and Precautions (5.7) ] Postoperative Decrease in Visual Acuity [see Warnings and Precautions (5.8) ] The most common adverse reactions (≥ 10%) were conjunctival hemorrhage, conjunctival hyperemia, iritis, eye pain, conjunctival disorder, cataract and vitreous hemorrhage. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice. The data below ( Table 2 ) reflect exposure of 248 patients with AMD in the Archway study through Week 40, 320 patients with DME in the Pagoda study up to Week 64, and 105 patients…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. [see Contraindications (4.1) , Warnings and Precautions (5.1) ] . WARNING: ENDOPHTHALMITIS See full prescribing information for complete boxed warning. The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab.
Warnings
Important safety information
The SUSVIMO implant and/or implant-related procedures have been associated with endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival erosion, conjunctival retraction, and conjunctival blebs. Patients should be instructed to report any signs or symptoms that could be associated with these events without delay. In some cases, these events can present asymptomatically. The implant and the tissue overlying the implant flange should be monitored routinely following the implant insertion, and refill-exchange procedures to permit early medical or surgical intervention as necessary. Special precautions need to be taken when handling SUSVIMO components [see How Supplied/Storage and Handling (16.3) ]. The SUSVIMO implant and/or implant-related procedures have been associated with endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival retraction, conjunctival erosion, and conjunctival bleb. Patients should be instructed to report signs or symptoms that could be associated with these events without delay. Additional surgical and/or medical management may be required. ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 ) Vitreous Hemorrhage : Temporarily discontinue antithrombotic medication prior to the implant insertion procedure to reduce the risk of vitreous hemorrhage. Vitrectomy may be needed. ( 5.5 ) Postoperative Decrease in Visual Acuity : A decrease in visual acuity usually occurs over the first two postoperative months. ( 5.8 ) 5.1 Endophthalmitis In the active comparator period of controlled clinical trials in AMD, the ranibizumab implant has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab (1.7% in the SUSVIMO arm vs 0.5% in the intravitreal arm). When including extension phases of clinical trials, 2% (11/555) of patients receiving the ranibizumab implant experienced an episode of endophthalmitis. Reports occurred between days 5 and 853, with a median of 173 days. Many, but not all, of the cases of endophthalmitis reported a preceding or concurrent conjunctival retraction or erosion event. In the active comparator period of the controlled clinical trial in DME, 0% of patients in the SUSVIMO arm compared to 0.3% in the intravitreal arm experienced an episode of endophthalmitis. When including the extension phase of the clinical trial, 0.7% (4/556) of patients receiving the ranibizumab implant experienced an episode of endophthalmitis. Reports occurred between days 625 and 1016, with a median of 824 days. In the period with an observational comparator arm of the clinical trial in DR, there were no patients (0/105) in the SUSVIMO arm who experienced an episode of endophthalmitis [see Clinical Studies (14.3) ] . When including the extension phase of the clinical trial 0.8% (1/128) patients receiving the ranibizumab implant experienced an episode of endophthalmitis, with the event reported on day 695. Endophthalmitis should be treated promptly in an effort to reduce the risk of vision loss and maximize recovery. The SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed until resolution of endophthalmitis [see Dosage and Administration (2.10) and Adverse Reactions (6.1) ] . Patients should not have an active or suspected ocular or periocular infection or severe systemic infection at the time of any SUSVIMO implant or refill procedure. Appropriate intraoperative handling followed by secure closure of the conjunctiva and Tenon's capsule, and early detection and surgical repair of conjunctival erosions or retractions and strict/controlled aseptic technique conditions throughout refill-exchange procedures may reduce the risk of endophthalmitis [see Dosage and Administration (2.1) and Warnings and Precautions (5.5) ] . 5.2 Rhegmatogenous Retinal Detachment Rhegmatogenous retinal detachments have occurred in clinical trials of SUSVIMO and may result in vision loss. Rhegmatogenous retinal detachments should be promptly treated with an intervention (e.g., pneumatic retinopexy, vitrectomy, or laser photocoagulation). SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed in the presence of a retinal detachment or retinal break [see Dosage and Administration (2.10) ] . Careful evaluation of the retinal periphery is recommended to be performed, and any suspected areas of abnormal vitreo-retinal adhesion or retinal breaks should be treated before inserting the implant in the eye. 5.3 Implant Dislocation In clinical trials, the device has dislocated/subluxated into the vitreous cavity or has extended outside the vitreous cavity into or beyond the subconjunctival space. Device dislocation requires urgent surgical intervention. Strict adherence to the scleral incision length and appropriate targeting of the pars plana during laser ablation may reduce the risk of implant dislocation. 5.4 Septum Dislodgement In clinical trials, a type of implant damage where the septum has dislodged into the implant body has been reported. Perform a dilated slit lamp exam and/or dilated indirect ophthalmoscopy to inspect the implant in the vitreous cavity through the pupil prior to and after the refill-exchange procedure to identify if septum dislodgement has occurred. Discontinue treatment with SUSVIMO (ranibizumab injection) following septum dislodgement and consider implant removal should the benefit of the removal procedure outweigh the risk [ see Dosage and Administration (2.9) ]. The benefits and risks of retaining, removing, or removing and replacing an implant with a dislodged septum are not well characterized. Appropriate handling and insertion of the refill needle into the septum (avoid twisting and/or rotation) is required to minimize the risk of septum dislodgement [ see Dosage and Administration (2.8) ]. 5.5 Vitreous Hemorrhage Vitreous hemorrhages may result in temporary vision loss. Vitrectomy may be needed in the case of a non-clearing vitreous hemorrhage [see Dosage and Administration (2.10) ] . In clinical trials of SUSVIMO including the extension phases in patients with AMD, vitreous hemorrhages were reported in 5.2% (23/443) of patients receiving SUSVIMO. In the clinical trial of SUSVIMO including the extension phases in patients with DME, vitreous hemorrhages were reported in 10.1% (56/556) of patients receiving SUSVIMO. In the clinical trial of SUSVIMO including the extension phase in patients with DR, vitreous hemorrhages were reported in 9.4% (12/128) of patients receiving SUSVIMO. The majority of these hemorrhages occurred within the first post-operative month following surgical implantation and the majority of vitreous hemorrhages resolved spontaneously. Patients on antithrombotic medication (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) may be at increased risk of vitreous hemorrhage. Antithrombotic medications are recommended to be temporarily interrupted prior to the implant insertion procedure. The SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed in the event of sight-threatening vitreous hemorrhage. The use of pars plana laser ablation and scleral cauterization should be performed to reduce the risk of vitreous hemorrhage. 5.6 Conjunctival Erosion or Retraction A conjunctival erosion is a full thickness degradation or breakdown of the conjunctiva in the area of the implant flange. A conjunctival retraction is a recession or opening of the limbal and/or radial peritomy. Conjunctival erosions or retractions have been associated with an increased risk of endophthalmitis, especially if the implant becomes exposed. Surgical intervention (e.g., conjunctival/Tenon's capsule repair) is recommended to be performed in case of conjunctival erosion or retraction with or without exposure of the implant flange. In clinical trials of SUSVIMO including the extension phases in patients…
Who should not take Susvimo
Ocular or periocular infections ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections SUSVIMO (ranibizumab injection) is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation SUSVIMO (ranibizumab injection) is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity SUSVIMO (ranibizumab injection) is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in SUSVIMO (ranibizumab injection).
Storing Susvimo, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store SUSVIMO initial fill needle kit at 2°C to 8°C (36°F to 46°F).”
- “Store SUSVIMO (ranibizumab injection) 100 mg/ mL vial at 2°C to 8°C (36°F to 46°F).”
- “Store the SUSVIMO implant and insertion tool assembly, refill needle and explant tool at room temperature 15°C to 25°C (59°F to 77°F).”
- “Store the SUSVIMO initial fill needle at 2°C to 25°C (36°F to 77°F).”
Drug class
How this class works, per Aflibercept - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Susvimo ranks — best-rated vascular endothelial growth factor inhibitor for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Request a 90-day supply
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Frequently asked questions
- What does Susvimo treat?
- Susvimo (Ranibizumab) may be used to treat diabetic retinopathy, macular edema, retinal vein occlusion, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Susvimo work?
- Susvimo is a vascular endothelial growth factor inhibitor. VEGF inhibitors block VEGF, the signal that tells the body to grow new blood vessels. By soaking up or blocking this signal, they starve tumors of the new vessels they need to grow, or calm the leaky abnormal vessels that damage the retina in eye diseases.
- How is Susvimo rated?
- pharmaranks gives Susvimo a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Susvimo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Susvimo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Susvimo?
- Susvimo is marketed by Genentech Inc. You can see Genentech Inc's full profile, rating, and other products on pharmaranks.
- Is Susvimo a brand-name or generic drug?
- Susvimo is a brand-name product with the active ingredient Ranibizumab.
- Is Susvimo available over the counter?
- No. Susvimo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Susvimo come in?
- Susvimo is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Susvimo?
- Susvimo is classified as vascular endothelial growth factor inhibitor, per the FDA's Established Pharmacologic Class.
- Is Susvimo FDA-registered?
- Susvimo is on record with the U.S. FDA under application number BLA761197. You can verify this on its official FDA label.
- Has Susvimo been recalled by the FDA?
- Yes. Susvimo has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Susvimo safe?
- There's no single safe-or-not verdict. pharmaranks gives Susvimo a recall-safety score of 72/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Susvimo?
- Susvimo's side effects are taken directly from its FDA label. From the label: The following adverse reactions are discussed in greater detail in other sections of the label: Endophthalmitis [see Warnings and Precautions (5.1) ] Rhegmatogenous Retinal Detachment [see Warnings and Precautions (5.2) ] Implant Dislocation [see Warnings and Precautions (5.3) ] Septum Dislodgement… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about RANIBIZUMAB
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 5,286 reports naming RANIBIZUMAB — the active ingredient in Susvimo, and the FDA flagged 97% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- visual acuity reduced550 reports
- retinal haemorrhage275 reports
- cerebrovascular accident272 reports
- vitreous haemorrhage202 reports
- endophthalmitis199 reports
- myocardial infarction197 reports
- cataract160 reports
- visual impairment156 reports
Read these as a signal, not a rate. A report does not mean RANIBIZUMAB caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 26, 2026.
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susvimo
72/100