Medical Policy

A port delivery system (PDS) is a novel type of drug delivery platform using a permanent drug-eluting implant inserted into and through the sclera of the eye to allow delivery of drugs to the intravitreal space. Such systems consist of a transscleral device that includes a reservoir and release control element to distribute drugs within the eye. A self-sealing extrascleral flange, which is visible through the conjunctiva, allows refilling of the reservoir as needed. Individuals can go up to 6 months between scheduled refills. PDS have been proposed as an alternative to monthly intravitreal injections in the treatment of retinal and potentially other ocular diseases.

Note: For information on ocular encapsulated cell therapy using revakinagene taroretcel-lwey see the following:

• MED.00153 Encapsulated Cell Therapy for Degenerative Ocular Disease

Note: For a high-level overview of this document, please see “Summary for Members and Families” below. 

Investigational and Not Medically Necessary:

The use of a port delivery system to treat ocular disease is considered investigational and not medically necessary for all indications.

This document describes clinical studies and expert recommendations, and explains whether a small device placed in the white part of the eye that slowly releases medicine into the inside of the eye over time, so people don’t need frequent eye injections, is appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

A port delivery system (PDS) is a small device implanted in the eye that slowly releases a drug over time to treat certain eye diseases. It is designed to reduce the need for frequent eye injections, which are commonly used to treat conditions like age-related macular degeneration (AMD), diabetic eye disease, and macular edema. The device is surgically placed into the white part of the eye and refilled with medication every few months. Although this system helps reduce the number of treatments, it may cause serious eye problems, including infections and damage to the eye. Because of these concerns, the use of a PDS to treat eye disease is still being studied and is not recommended as standard care.

What the Studies Show

The PDS releases an anti-vascular endothelial growth factor (anti-VEGF) drug called ranibizumab (brand name Susvimo) to treat eye diseases that can cause vision loss. Studies have shown that the device may work as well as monthly injections for preserving vision over short periods of time. However, people who received the device had more eye-related problems than those who got injections. Serious side effects included eye infections, bleeding, implant movement, and damage to the tissues around the implant. One study showed a three-times higher risk of infection compared to monthly injections, which led the U.S. Food and Drug Administration (FDA) to add a Black Box Warning about this risk.

Other studies showed the device can reduce how often injections are needed, and many people preferred it to injections. But the results also showed that many people still had serious side effects. Some needed surgery to remove or fix the device. Although some people kept good vision with the device, long-term safety is still unclear, and experts say more research is needed.

Is this clinically appropriate?

This treatment is not appropriate because it has not been proven to improve health. Studies show that although the device may work as well as monthly injections in the short term, it may cause more serious eye problems. These include infections, implant dislocation, and vision loss. Long-term results are still unknown, and past issues with the device led to a recall. Better studies are needed to know if this device is safe and helpful over time. Using treatments that have not been fully tested can lead to harm, such as unnecessary procedures, or worsening vision. Because of these risks, this device is considered investigational and not medically necessary for any use.

(Return to Description/Scope)

Summary

PDSs are permanent, refillable intraocular implants designed to provide continuous anti-VEGF therapy as an alternative to monthly injections, but current evidence shows that their safety, durability, and real-world effectiveness remain insufficient to support clinical use. Although phase 2 and 3 trials in neovascular AMD, diabetic macular edema (DME), and diabetic retinopathy (including Ladder, Archway, Portal, Pagoda, and Pavilion) demonstrated short-term noninferior visual outcomes compared with monthly injections, the trials consistently reported substantially higher rates of ocular complications. These complications included conjunctival erosion, conjunctival retraction, vitreous hemorrhage, implant dislocation, septum dislodgement, and a three-fold increased risk of endophthalmitis leading to an FDA Black Box Warning. Long-term safety remains uncertain due to limited follow-up, the need for repeated refills, and prior device durability concerns, including a 2022 voluntary recall for septum failures. Trials were also constrained by short duration, selective enrollment, and dependence on a highly skilled surgical technique, limiting generalizability to routine practice. Given these unresolved safety issues, procedural invasiveness, and lack of proven long-term benefit over existing therapies, the use of PDSs for ocular disease remains investigational and not medically necessary.

Discussion

Wet or neovascular age-related macular degeneration (AMD)

Untreated AMD will result in progressive vision loss. The current treatments of neovascular AMD include photodynamic or intravitreal injections of an anti-VEGF. Anti-VEGF therapy blocks the VEGF protein, slowing the growth of abnormal blood vessels and slowing the rate of vision loss. The current U.S. Food and Drug Administration (FDA) approved anti-VEGF agents include bevacizumab (Avastin), aflibercept (Eylea) and ranibizumab (Lucentis). Individuals with AMD typically require monthly intravitreal injections. The use of anti-VEGF therapy has been used for other ocular disease including macular edema, diabetic retinopathy and retinal vein occlusion. However, the vision gains reported by the use of anti-VEGF agents in clinical trials have not replicated in clinical practice. In clinical practice, initial vison gains shown were lost or significantly reduced in later years. This reduced efficacy appears to be related to the treatment regimen. Khanani and colleagues (2021) reported that individuals who remain on long-term fixed-interval anti-VEGF therapy maintained vision outcomes through year 7. The implanted, refillable PDS has been proposed as a way of reducing treatment burden without compromising vision through the sustained release of an anti-VEGF agent. The PDS decreases the number of intravitreal injections an individual needs to undergo, as the reservoir only needs to be refilled approximately every 6 months. Currently the only anti-VEGF agent FDA approved for use with the PDS is ranibizumab.

On October 22, 2021, the FDA approved Susvimo^™ (Genentech, Inc. South San Francisco, CA), a form of the biologic drug ranibizumab, for intravitreal use via a PDS ocular implant for the treatment of neovascular AMD. Susvimo and the ocular implant are meant to be used in those who had previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.

Holekamp and associates (2021) reported on the results of a phase 3, open-label, randomized, visual acuity assessor-masked noninferiority and equivalence trial (Archway). Individuals aged 50 years or older with a diagnosis of neovascular AMD made within 9 months of screening, with a positive response to at least three prior anti-VEGF intravitreal injections, were randomized to receive either the PDS with ranibizumab (n=248) or intravitreal injections every 4 weeks (n=167). The primary end point was established as the change in best-corrected visual acuity (BCVA) score from baseline averaged over weeks 36 and 40. A total of 240 (96.8%) individuals in the PDS group and 162 (97.0%) individuals in the monthly injection group completed the study through week 40. The change in the BCVA score from baseline averaged over weeks 36 and 40 was +0.2 in the PDS group and +0.5 in the monthly injection group. Based on the pre-study standards, the PDS was clinically noninferior and equivalent to the monthly injections. The PDS group reported more ocular adverse events (AEs) compared to the monthly injection group, with most events occurring during the post-operative period. In addition to non-serious AEs, there were a total of 20 serious AEs occurring in the PDS group including conjunctival erosion, conjunctival retraction, endophthalmitis, rhegmatogenous retinal detachment, necrotizing retinitis, retinal tear, visual acuity reduced, vision impairment, choroidal detachment and implant dislocation. There were 2 serious AEs in the monthly injection group including vitreous hemorrhage and facial bone fracture. The rate of AEs in this trial resulted in the FDA inserting a Black Box Warning to the prescribing information (PI) label. The study analysis included data from only one complete refill interval. Further studies with longer follow-up are needed.

In 2023, the 2-year results of the Archway trial were reported by Regillo. Following an initial transient and reversible decrease in BCVA in the implantation group, both groups reported similar mean BCVA change from baseline through week 96. An additional 8 serious ocular AEs were reported in the implantation group compared to 2 in the monthly injection group. These serious ocular AEs included 3 cases of implant dislocation and conjunctival erosion, reduced visual acuity, cataract cortical, conjunctival bleb, corneal disorder, retinal pigment epithelial tear, scleral thinning, retinal tear and endophthalmitis. One individual in the implantation group experienced a traumatic cataract which was the result of surgical removal of a dislocated implant. The 4 cases of implant dislocation were treated with implant removal. The vision returned to baseline in 3 individuals. The 4^th individual experienced additional complications and the vision remained markedly decreased (Snellen equivalent 20/32 at baseline compared to < 20/200 at last available visit). These cases were attributed to surgical error regarding length of the surgical incision. There were 3 cases of implant septum dislodgement with 2 cases occurring after at least 1 refill-exchange procedure. The third case occurred 112 days after the 3^rd refill-exchange procedure. Additional follow-up data is being collected through 5 years post-implantation. The authors note:

However, whether or not these or other novel long-lasting treatments are able to respond to the unmet medical need for reduced treatment burden in nAMD will depend not only on their effectiveness in gaining and maintaining visual function but also on their overall long-term safety profile.

Campochiaro published interim results of an extension clinical trial titled the Portal Extension Trial (2025). Individuals who had participated in the Archway or Ladder trials (n=555) participated with a mean follow-up of 111 weeks. Participants from the monthly injection groups in the original studies were transitioned to a PDS. All participants received refill exchanges of ranibizumab every 24 weeks. All participants were evaluated at 8 and 4 weeks prior to scheduled refill for decrease in BCVA, triggering supplemental treatment. Approximately 24.7% of participants experienced at least 1 ocular AE of special interest, the most common being cataracts (11.4%). Endophthalmitis was documented in 2.0% of participants (11/555). Over a period of 48 months, visual acuity remained stable for these individuals, with a mean change in BCVA of 0.1 letters for those previously treated with the implant 100 mg/mL and 2.3 letters for those who received monthly ranibizumab. Approximately 95% of participants did not require supplemental treatment between refill exchanges, and 92% preferred the PDS over traditional injections. While these interim results suggest that the visual and anatomic outcomes can be sustained over at least 48 months, the data available at the cutoff data included only a small number of individuals. A more comprehensive evaluation of the long-term outcomes can be done when further data is available.

In a phase 2, multicenter, randomized, active treatment controlled clinical trial, Campochiaro (2019) reported on the safety and efficacy of the PDS used with ranibizumab. The inclusion criteria included those aged 50 and older who had been diagnosed within 9 months of study screening and who had been responsive to between 2 and 9 anti-VEGF agent injections. Individuals receiving monthly intravitreal injections (n=41) were compared to individuals receiving ranibizumab at varying concentration levels with the PDS including 10 mg/ml (n=58), 40 mg/ml (n=62) and 100 mg/ml (n=59). The primary endpoint was the time to first implant refill. Additionally, improvement in BCVA, central foveal thickness (CFT) and safety endpoints were assessed. The PDS used with the 100 mg/ml concentration reported the highest efficacy rate, with only 1.7% of participants not meeting clinical efficacy criteria. The lower concentration groups reported 22.4% and 4.8% of participants did not meet clinical efficacy criteria. The BCVA and CFT were similar across the monthly injection group and the PDS concentration 100 mg/ml group. The monthly injection group did not report any serious ocular AEs. The PDS groups reported serious ocular AEs in 8.9% (16/179) of participants. This phase 2 study met its primary objective of assessing the relative efficacy of PDS therapy at varying formulations. Further studies beyond this proof-of-concept study are needed to fully evaluate implications of using a permanent refillable intraocular reservoir to deliver biologic therapy for neovascular AMD.

The use of anti-VEGF agents such as ranibizumab are very effective and are considered standard therapy to treat neovascular AMD. In clinical practice, long-term visual acuity outcomes are worse than outcomes reported in clinical trials. This is likely due to compliance issues resulting in decreased monitoring and treatment frequency (Holekamp, 2021). The PDS is being evaluated as an alternative to monthly injections which may increase treatment compliance. The PDS is more invasive than the current approach and is associated with a significantly increased risk of endophthalmitis. Additional research is needed to evaluate the long-term performance and complication rate of the PDS. Longitudinal data is needed to confirm potential improved visual outcomes and real-world results will not be available for several years. In addition, further investigation is needed to address whether treatment with the PDS is generalizable to a more diverse clinical population, including those living with a longstanding neovascular AMD diagnosis. A clinical trial (NCT03683251) is underway to further evaluate the individuals in previous trials for approximately 240 weeks. The estimated study completion date is December 2026. Interim results have been published (Campochiaro, 2025).

Diabetic Retinopathy or DME

Diabetic retinopathy is a diabetes-related condition characterized by damage to the retinal blood vessels due to prolonged high blood sugar levels, leading to vision impairment and potentially blindness. It progresses through various stages, from mild to severe nonproliferative diabetic retinopathy, to proliferative diabetic retinopathy, which involves neovascularization and can significantly threaten vision. Diabetic macular edema is a specific manifestation of diabetic retinopathy, involving the accumulation of fluid in the macula due to increased vascular permeability and retinal swelling. This results in significant visual distortion or loss, especially central vision. The relationship between diabetic retinopathy and diabetic macular edema is intrinsic: as diabetic retinopathy progresses, particularly to more advanced stages like PDR, the risk of developing diabetic macular edema increases, exacerbating the impact on vision. Effective management of diabetic retinopathy is crucial in reducing the risk and impact of diabetic macular edema, making careful monitoring and timely intervention essential to prevent severe vision loss.

On February 4, 2025, the FDA expanded the approved indications for Susvimo to include treatment of individuals with DME who have previously responded to at least 2 intravitreal injections of a VEGF inhibitor. The FDA approval was supported by results from the Pagoda trial (Khanani, 2025), a phase 3, randomized, visual assessor-masked, active-controlled study evaluating continuous ranibizumab delivery via the PDS every 24 weeks compared with monthly intravitreal ranibizumab for treatment of DME. Adults with center-involved DME (PDS n=381; monthly injections n=253) were followed for 64 weeks, with the primary endpoint defined as the change in BCVA averaged over weeks 60 and 64. The PDS demonstrated noninferiority, achieving a mean gain of +9.6 letters, comparable to +9.4 letters with monthly injections. As expected, the surgical implantation led to a transient early postoperative decrease in vision (mean drop of ~4 letters in the first month). While the PDS substantially reduced treatment frequency, it was associated with a higher incidence of ocular AEs, including conjunctival complications, vitreous hemorrhage, and other implant-related events. Across the PDS arm, 925 ocular AEs occurred in 91.9% of participants, including 12 serious events (5 conjunctival erosions, 4 conjunctival blebs, and 1 each of cataract, conjunctival retraction, vitreous hemorrhage, and implant dislocation). Isolated device-related complications included one implant dislocation requiring explantation and one septum dislodgement after two refill exchanges. In contrast, the monthly injection arm reported 359 ocular AEs in 44.6% of participants and 2 serious events (cataract and endophthalmitis). Limitations of the trial included variability in postoperative responses, procedural complexity requiring experienced surgeons, and the need for ongoing evaluation of long-term safety and device durability.

Susvimo received FDA approval for diabetic retinopathy on May 22, 2025 based on results from the phase 3 Pavilion trial (Pieramici, 2025). The Pavilion trial was a multicenter, randomized, partially masked study evaluating the PDS with ranibizumab refilled every 36-40 weeks in individuals with moderately severe to severe nonproliferative diabetic retinopathy without center-involved DME. In Pavilion, 174 participants underwent monthly monitoring, with examiners and reading-center graders masked to treatment assignment. The primary endpoint was the proportion of participants achieving a ≥ 2-step improvement in Early Treatment Diabetic Retinopathy Study - Diabetic Retinopathy Severity Scale (ETDRS-DRSS) at week 52, which was met with a marked difference between groups: 80.1% of PDS-treated participants improved vs. 9.0% in the control arm (difference 71.1%, p<0.001). The PDS group also showed reduced progression to center-involved DME, proliferative diabetic retinopathy, or anterior segment neovascularization (7.1% vs. 47.0%, p<0.001) and a modest improvement in BCVA (+1.4 letters vs. -2.6 letters, p<0.01). No participants required supplemental anti-VEGF injections. Safety findings were consistent with the established Susvimo profile, including expected conjunctival and peri-implant events. Limitations included unclear details regarding control-arm management, the relatively short 52-week follow-up, and the need for further long-term data addressing visual acuity, central subfield thickness, and treatment burden.

The standard of care for diabetic retinopathy involves regular screenings, effective management of blood pressure and glucose levels, and appropriate therapeutic interventions. The American Academy of Ophthalmology (AAO) preferred practice pattern regarding diabetic retinopathy (2024) emphasizes annual dilated fundus examinations, management of glucose and blood pressure, and the use of intravitreal anti-VEGF agents for treating center-involved diabetic macular edema and proliferative diabetic retinopathy. Panretinal photocoagulation remains a primary treatment for proliferative diabetic retinopathy. While the Pagoda and Pavilion trials provided short-term data regarding clinical outcomes compared to current accepted treatments, additional data regarding long-term outcomes and using real world clinical settings are needed.

Warnings

The PI label (2025) includes the following Black Box Warning regarding endophthalmitis:

The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab.

The FDA also requested the following additional warnings and precautions be included in the label:

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 any signs or symptoms that could be associated with these events without delay. Additional surgical and/or medical management may be required.

Vitreous Hemorrhage: Temporarily discontinue antithrombotic medication prior to the implant insertion procedure to reduce the risk of vitreous hemorrhage. Vitrectomy may be needed.

Postoperative Decrease in Visual Acuity: A decrease in visual acuity usually occurs over the first two postoperative months.

Voluntary Recall

In October 2022, the Susvimo ocular implant and initial fill needle were voluntarily recalled due to issues with the durability of the product over the long-term following multiple refills. In clinical trials, the septum of the implant has become dislodged from the implant body resulting a potential for medication leakage. The recall does not include the refill equipment. For individuals with a defective implant, further refill-exchange procedures should not be performed. The manufacturer notes “The long-term risks of retaining vs. removing an implant with a dislodged septum are not well characterized at this time.” In March 2025, the manufacturer provided additional information regarding the recalled devices and the known risk of septum dislodgement.

Timmons and associates (2022) reported on an individual who experienced an implanted septum dislodgement case in a clinical trial. Post refill implant photography after the third refill revealed that the septum had fallen into the implant reservoir. The septum began a downward migration following device implantation and progressed with each subsequent refill. The provider confirmed the correct refill procedure was followed and penetration of the septum was achieved on the first attempt at each refill. The presence of the implant with a nonfunctioning seal may be associated with a risk of intraocular inflammation. The voluntary recall was lifted in April 2024.

AEs

Campochiaro and associates (2024) categorized a group of AEs as potentially related to the device or insertion of the device as AEs of special interest noting:

These ocular AESIs [adverse events of special interest] were AEs that were considered to be potentially related to the PDS implant or implant insertion procedure, as follows: cataract (i.e., cataract, cataract nuclear, cataract cortical, and cataract subcapsular), conjunctival thickening (bleb) or thickening filtering (bleb) leak, conjunctival erosion, conjunctival retraction, endophthalmitis, hyphema, implant dislocation, rhegmatogenous retinal detachment, vitreous hemorrhage, and septum dislodgement (nonprespecified AESI, defined as a type of device deficiency where the septum has dislodged into the body of the implant and normal device functioning cannot be assured).

Holekamp and associates (2024) systematically compared the long-term safety and complications of the PDS with ranibizumab against other ocular implants. The authors reported that the PDS reported comparable safety profiles to established ocular implants, with device-related complications noted at median rates of 0.7% in clinical trials and 1.3% in real-world studies, and conjunctival complications at 2.1% and 2.2% respectively across clinical trials (n=16) and real-world studies (n=43). The authors concluded further long-term studies are needed noting:

Further studies with longer follow-up, larger sample sizes, and a greater range of pre-specified, consistently defined complications will help contextualize and build confidence regarding the long-term safety of ocular implants, including the PDS.

The ocular implant used with Susvimo is inserted during an outpatient procedure, with the reservoir filled prior to placement. The implant is surgically placed in an incision through the sclera and pars plana. The implant contains a self-sealing septum used to refill the port. The drug is continuously released into the vitreous through passive diffusion. The reservoir is refilled approximately every 6 months during an office setting visit.

AMD is the leading cause of vision loss in older adults, affecting approximately 11 million people in the U.S. AMD is categorized as either dry or atrophic AMD, which is more common, and wet or advanced neovascular AMD. Neovascular AMD is characterized by macular or choroidal neovascularization, fluid leakage and central vision loss. Monthly intravitreal anti-VEGF therapy is considered the standard of care therapy for wet AMD. In clinical practice, decreased treatment frequency over time is often reported and has been identified as a possible cause of reduced VEGF therapy effectiveness in clinical practice compared to clinical trials (Khanani, 2021).

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:

When services may also be Investigational and Not Medically Necessary:
For the following procedure code or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Campochiaro PA, Eichenbaum D, Chang MA, et al. Interim results of the phase III portal extension trial of the port delivery system with ranibizumab in neovascular age-related macular degeneration. Ophthalmol Retina. 2025; 9(2):144-155.
2. Campochiaro PA, Maass KF, Singh N, Barteselli G. Reply. Ophthalmology. 2019; 126(11):e88-e89.
3. Campochiaro PA, Marcus DM, Awh CC, et al. The port delivery system with ranibizumab for neovascular age-related macular degeneration: results from the randomized phase 2 Ladder clinical trial. Ophthalmology. 2019; 126(8):1141-1154.
4. Holekamp NM, Campochiaro PA, Chang M, et al.; Archway Investigators. Archway randomized phase 3 trial of the port delivery system with ranibizumab for neovascular age-related macular degeneration. Ophthalmology. 2022; 129(3):295-307.
5. Holekamp NM, Yaqub M, Ranade SV, et al. Systematic literature reviews comparing the long-term safety outcomes for the port delivery system with ranibizumab (PDS) versus other ocular implants. Ophthalmol Ther. 2024; 13(9):2303-2329.
6. Khanani AM, Aziz AA, Weng CY, et al. Port delivery system: a novel drug delivery platform to treat retinal diseases. Expert Opin Drug Deliv. 2021; 18(11):1571-1576.
7. Khanani AM, Callanan D, Dreyer R, et al.; of the Ladder Investigators. End-of-study results for the Ladder Phase 2 trial of the port delivery system with ranibizumab for neovascular age-related macular degeneration. Ophthalmol Retina. 2021; 5(8):775-787.
8. Khanani AM, Campochiaro PA, Graff JM, et al. Continuous ranibizumab via port delivery system vs monthly ranibizumab for treatment of diabetic macular edema: the pagoda randomized clinical trial. JAMA Ophthalmol. 2025; 143(4):326-335.
9. Pieramici DJ, Awh CC, Chang M, et al. Port delivery system with ranibizumab vs monitoring in nonproliferative diabetic retinopathy without macular edema: the pavilion randomized clinical trial. JAMA Ophthalmol. 2025; 143(4):317-325001.
10. Regillo C, Berger B, Brooks L, et al. Archway phase 3 trial of the port delivery system with ranibizumab for neovascular age-related macular degeneration 2-year results. Ophthalmology. 2023; 130(7):735-747.
11. Sharma A, Khanani AM, Parachuri N, et al. Port delivery system with ranibizumab (Susvimo) recall- what does it mean to the retina specialists. Int J Retina Vitreous. 2023; 9(1):6.
12. Sharma A, Kumar N, Kuppermann BD, Francesco B. Re: Campochiaro et al.: The port delivery system with ranibizumab for neovascular age-related macular degeneration: results from the randomized phase 2 Ladder clinical trial (Ophthalmology. 2019;126:1141-1154). Ophthalmology. 2019; 126(11):e87-e88.
13. Timmons K, Heckmann LC, Ren Y, et al. Ranibizumab injection (Susvimo) implant septum dislodgement in a patient with neovascular age-related macular degeneration. JAMA Ophthalmol. 2022; 140(8):832.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Ophthalmology (AAO). For additional information, see the AAO website at https://www.aao.org/. Accessed on December 2, 2025.
   • Age-Related Macular Degeneration Preferred Practice Pattern^®. Approved on February 2025.
   • Diabetic Retinopathy Preferred Practice Pattern. Approved on June 2024.
2. Genentech. Dear Health Care Provider Letter. Subject: Update on SUSVIMO^® Ocular Implants Voluntarily Recalled in October 2022 - Potential to Affect the Refill-Exchange Procedure. March 2025. Available at: https://www.gene.com/download/pdf/Susvimo_DHCP_Important-Prescribing-Information_March2025.pdf. Accessed on December 3, 2025.
3. Susvimo [Product Information], South San Francisco, CA. Genentech, Inc.; Updated on September 2025. Available at: https://www.gene.com/download/pdf/susvimo_prescribing.pdf. Accessed on December 2, 2025.
4. U.S. National Library of Medicine. Clinical Trials.
   • NCT03683251. A multicenter, open-label extension study to evaluate the long-term safety and tolerability of the port delivery system with Ranibizumab in patients with neovascular age-related macular degeneration (Portal). Last updated November 4, 2025. Available at: https://clinicaltrials.gov/ct2/show/NCT03683251. Accessed on December 3, 2025.

1. National Institute of Health (NIH). National Eye Institute. Age-Related Macular Degeneration. Last updated: June 22, 2021. Available at: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration. Accessed on December 3, 2025.
2. The American Society of Retina Specialists (ASRS). Age-Related Macular Degeneration. Available at: https://www.asrs.org/patients/retinal-diseases/2/agerelated-macular-degeneration. Accessed on December 3, 2025.

Susvimo

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

© CPT Only – American Medical Association