Sustained-release medication for age-related macular degeneration (AMD) and diabetic eye disease is transforming the treatment landscape.
Susvimo (ranibizumab injection, 100 mg/mL), delivered via the Port Delivery System (PDS), is the first and only FDA-approved continuous delivery system for both neovascular AMD (nAMD), diabetic macular edema (DME), and
diabetic retinopathy (DR), significantly reducing the frequency of intravitreal injections while maintaining visual outcomes.
1,2 For nAMD, the
phase 3 ARCHWAY trial showed that Susvimo, with biannual refills, maintained vision comparable to monthly intravitreal ranibizumab, with
95% of patients not requiring supplemental injections.
Most recently, the
FDA approved Susvimo for DR in May 2025 based on results from the
phase 3 PAVILION trial, wherein
80% of patients achieved a ≥2-step improvement in DR severity with a single refill every
9 months—making it the first approved therapy capable of such sustained efficacy for DR.
1,2Additionally,
Susvimo was approved for DME in February 2025 following the
phase 3 PAGODA study, marking another milestone as the first continuous delivery DME treatment that maintains vision with fewer injections than standard of care.
1Although the implantation and refill procedures require surgical precision and carry risks such as conjunctival complications or endophthalmitis, outcomes are generally favorable with appropriate patient selection and technique. We spoke with Michael Klufas, MD, who shared his insights on implanting this device.
What do you feel are the benefits of Susvimo?
Our treatment paradigm has been to have many patients start on injections, but in my experience, there are some patients who just don't like the injection process. I mean, none of us would love to get an injection in our eye. In other instances, the patient is not able to go beyond 4 to 6 weeks, even with newer agents like
Eylea HD or
Vabysmo, so Susvimo is a good alternative for them.
Doctors are a little mistaken in considering it to be the same thing as monthly injections of ranibizumab (Lucentis), but it's really a continuous therapy, so it's a more concentrated version. Using the same compound, this new treatment paradigm allows continuous release every day over 6 to 9 months, and then it can be refilled in the office.
Whether it's preference or medically indicated, it's a good treatment option as an alternative to injections for the right patient. Also, in terms of patient satisfaction, patients indicate high treatment satisfaction with both PDS and intravitreal injection, but the lower number of treatments with PDS was reported as a preferred choice.3
Can you speak briefly to complications?
Of course, it is a surgical procedure and the complication rate may be higher than the injection, but there have been a lot of advancements in the procedure and learnings over the past 10 years of development.
At this point,
thousands of these devices have been placed, so we've been able to tone down the initial complications, which included
vitreous hemorrhage and
infection. These things have certainly improved, and we're going to see more real-world evidence on it.
Are there any contraindications?
Because this is a permanent implant, if there's no healthy conjunctiva, I usually don't bring this device up with patients. We know that if there is erosion or retraction of the conjunctiva, then that increases the risk of infection.
Also, as this is a surgical procedure, if a patient is not able to come in for post-operative monitoring, compliance makes them a less-than-ideal candidate.
7 steps for Susvimo success
1. Follow the IFU provided by the manufacturer
Genentech has an awesome surgical excellence academy that everyone goes through prior to placing the device. In addition, they provide a surgical device liaison (SDL) who will come to the operating room with you.
They've developed this procedure over 10 years to make it so both you and the patient are successful, so I wouldn't deviate significantly from the IFU for the first couple of cases. Of course, you'll have your own nuances moving forward, but embrace the key learnings, which were designed to prevent complications.
2. Handle the conjunctiva with care
Make sure it's undermined and released and then closed properly without button holes over the conjunctiva. Use forceps that are non-toothed, so the tissue is not damaged.
3. Use a traction suture
This allows much better exposure of the supratemporal quadrant and makes it easier to allow the scleral incision to be made.
4. Make sure the incision is not more than 3.4 to 3.5 millimeters
In the past, incisions used to be up to 3.7mm, which created complications with the device dislocating. Though a rare occurrence, it is definitely something we don't want to have happen. If the opening does end up being larger and 3.5mm, a 10-0 nylon stitch can be placed to make the incision smaller.
After the scleral incision is made, we apply laser to prevent vitreous hemorrhage from the choroid, and then remeasure the incision, as the laser can make the incision a little smaller or larger. I like to undersize it a little bit, knowing I can always make it larger if needed.
5. Be prepared to utilize infusion if necessary
Place the infusion at the start of the case, but do not turn it on. It's often not necessary; however, as the incision is fairly large, if the eye becomes a little soft during insertion of the device, turn the infusion on. This allows the incision to accept it.
6. Adequately close the Tenon’s capsule and conjunctiva to ensure the device is well covered
We actually often recommend that the conjunctiva be repositioned a millimeter or two over the cornea, because we expect it to retract back. Make sure the conjunctiva is free and undermined, and then reposition it, putting over the conjunctiva, and let it heal.
7. Remember, these devices can be replaced if necessary
A really remarkable feature of this device is that it can be exchanged or replaced if post-operative complications develop. The conjunctiva can be revised if there are issues with it, and these eyes can do very well from a visual standpoint.
We do expect complications with surgery. Of course, we try to mitigate them, but with this device, a lot of the complications can be mitigated with repeat surgery and still yield good visual outcomes.
In conclusion
With the global prevalence of DR being 103 million in 2020 and expected to reach 161 million by 2045, Susvimo provides a compelling long-term treatment alternative, particularly for those seeking to minimize treatment burden without compromising efficacy.4
This represents a significant advancement in the management of chronic retinal diseases, offering a transformative alternative to frequent intravitreal injections through its continuous drug delivery system.
Backed by robust clinical trial data and growing real-world experience, it provides sustained efficacy for patients with nAMD, DR, and DME while reducing treatment burden and improving patient satisfaction.
Though not without surgical considerations, with proper training, technique, and patient selection, Susvimo offers a compelling option for both physicians and patients seeking long-term disease control and quality-of-life improvement in the evolving landscape of retinal care.