Susvimo: an implant replaces injections in wet AMD, but it does not make you see better

On 24 July 2026 the European Medicines Agency published a favourable opinion from its scientific committee for Susvimo, a reservoir implanted in the eye that releases an anti-VEGF drug continuously and is refilled roughly every six months. For someone who has been having repeated injections for years, the idea is appealing. What the head-to-head comparison with monthly injections actually shows deserves to be set out without hype: visual acuity is the same, and ocular complications are markedly more common. The advance is real, but it is not the one most people imagine.

THE ANNOUNCEMENT

What Europe recommended on 24 July 2026

The Committee for Medicinal Products for Human Use at the European Medicines Agency, which everyone calls the CHMP, meets every month to examine the dossiers submitted by drug companies. Its meeting of 20 to 23 July 2026 issued a favourable opinion for Susvimo, submitted by Roche Registration GmbH, for a carefully worded indication: “treatment of adults with neovascular age-related macular degeneration”, in other words the wet form of AMD.

It was the only ophthalmology product of that session. There was none at all in the previous one, at the end of June. That detail gives the measure of the real pace of innovation in our speciality: the announcements that make the headlines are rare, and they are counted in ones and twos per year, not per month.

“Recommended” is not “authorised”

The distinction is not administrative pedantry, and I repeat it in clinic whenever a patient arrives with a newspaper article in hand. The CHMP assesses and recommends; it is the European Commission that authorises. Until that decision has been taken, the product holds no European marketing authorisation.

And authorisation itself does not settle the question of access. A medicine authorised in Europe must then, in France, go through an assessment of the clinical benefit it provides, a price negotiation and a decision on reimbursement. Between the opinion of a European committee and the day your ophthalmologist can genuinely offer you something, there is a run of steps, not one of which is automatic.

Put plainly: if you are being followed for wet AMD and you have read somewhere that “the implant is on its way”, the honest answer to “when?” today is that nobody can give you a date.

THE PROBLEM

Why wet AMD means one injection after another

In the wet form of AMD, abnormal vessels grow beneath the retina and leak fluid and blood at the centre of vision. This is not slow ageing: it is a distortion of straight lines, then a patch at the centre of the visual field, and it can set in over a few weeks. The molecule that drives this vascular proliferation is called VEGF, and we know how to block it.

That is the principle behind intravitreal injections of anti-VEGF drugs, one of the clearest advances in ophthalmology of the past twenty years. They work. The problem has never been how well they work, it lies elsewhere: the drug breaks down inside the eye within a few weeks, so it has to be given again. And again. And again.

What that means in practice for a patient of 80: appointments close together, often monthly at the start, a journey to arrange, sometimes a relative called upon, a waiting room, an injection into the eye that is still dreaded even when it goes smoothly, and all of it for years on end. The literature has a name for this accumulation: treatment burden. It is what explains why some patients end up stretching the intervals, putting appointments off, then stopping altogether, and lose the ground they had gained.

One picture that gets around does need correcting straight away, though. In routine French practice, most patients do not receive twelve injections a year indefinitely. After the loading phase, the interval is matched to how active the disease is and stretched out progressively for as long as the retina stays dry. Many stable patients are seen every eight, ten or twelve weeks. The comparison used to assess the implant, on the other hand, sets it against a strict monthly schedule, the heaviest scenario of all. Keep that in mind as you read the results.

THE DEVICE

A reservoir in the eye rather than an injection every month

The principle is simple to state. Instead of reintroducing a dose of the drug at regular intervals, a small reservoir filled with ranibizumab is surgically implanted in the wall of the eye, and diffuses slowly and continuously towards the retina. The implant stays in place. When the reservoir empties, it is refilled through a septum, a self-sealing membrane reached with a dedicated needle, during a clinic visit.

Refilling comes round roughly every six months. Two procedures a year instead of twelve, in the heaviest scenario. That is where the whole promise of the device lies, and it needs naming precisely: this is not a promise of better vision, it is a promise of fewer procedures for the same vision.

Note, too, what the implant is not. It is not a new molecule: ranibizumab has been in use for years and its profile is known. Nor is it an electronic device or a prosthesis. It is a container. All of the innovation sits in the logistics of delivering the drug, not in the pharmacology, which is why, as we shall see, there is no reason for the visual result to be any different.

The trade-off is just as plain once you put it into words: placing a reservoir in the wall of an eye means surgery, and leaving that reservoir there permanently creates a site that did not exist before. An injection passes through the eye and seals over. An implant stays.

THE RESULTS

What the comparison with monthly injections shows

A meta-analysis published in 2026 in Seminars in Ophthalmology pooled the randomised trials that set the reservoir system directly against monthly ranibizumab. It brings together 3 trials and 1,149 eyes: 688 treated with the implant, 461 with monthly injections. Its scope is that of VEGF-driven macular disease, overwhelmingly wet AMD, only one of these three trials dealing with diabetic macular oedema. It is currently the most reliable synthesis available to answer the question a patient actually cares about.

Vision: no difference

In neovascular AMD, the mean difference in visual acuity between the two strategies is −0.69 letters, with a 95% confidence interval running from −2.52 to +1.14 and a p value of 0.46.

Let us translate that. A “letter” is one letter on the standardised reading charts used in research; five letters make up one line. A difference of 0.69 letters sits well below anything a human eye can perceive. And, more to the point, the confidence interval contains zero and p is 0.46: the data do not allow us to say that there is a difference, in one direction or the other. Central retinal thickness measured on imaging differs no more than acuity does; the anatomy confirms what the acuity says.

This is neither a disappointment nor a failure: it was precisely the objective. A device intended to show that it can replace an established treatment must first demonstrate that it does no worse. That has been done. But it also means that a patient hoping to see better thanks to the implant has the wrong end of the argument: nobody has ever shown that, and nobody has claimed it.

Complications: ocular risk almost doubled

This is where the balance shifts. Ocular adverse events are significantly more frequent with the implant: relative risk 1.80, confidence interval 1.49 to 2.17, p below 0.00001. A relative risk of 1.80 means that the risk of an ocular event is multiplied by 1.8 in the implant group compared with the injection group. The finding is clear-cut and the confidence interval is narrow: this is not a fragile signal.

The detail is instructive, because it points squarely to where the excess risk comes from. The complications that are significantly more frequent are leakage at the conjunctival bleb covering the implant (relative risk 15.29), erosion of the conjunctiva over the implant (8.87), conjunctival retraction (5.78), hyphaema, that is, blood in the anterior chamber of the eye (5.77), and vitreous haemorrhage (3.61).

These very high figures have to be read for what they are. First and foremost, they reflect the fact that such complications barely occur at all in the injection group: you do not get erosion over an implant when you have no implant. A ratio of 15 between two quantities, one of which is close to zero, impresses more than it informs. The question a patient would ask, “how many in a hundred?”, is not settled by these ratios, and that is a genuine limitation when it comes to informing an individual decision.

What does hold, on the other hand, is solid and consistent: the excess risk is local and tied to the presence of the implant itself, it concentrates on the outer surface of the eye and on bleeding, and it is of the order of a doubling. On the systemic side, nothing to report: general adverse events are comparable between the two strategies (relative risk 1.00).

One caveat to finish with, raised by the authors themselves: in diabetic macular oedema the data come from a single trial and the conclusions there remain exploratory. The European opinion covers wet AMD alone, in any case. If you are being followed for diabetic retinopathy, this news does not concern you at this stage.

THE BACKSTORY

The 2022 recall, and why it still matters

This device has a history, and leaving it out would give an incomplete picture. On 18 October 2022, a voluntary class III recall was registered with the American drug agency. The reason: separation of the septum, that is, of the membrane through which the reservoir is refilled.

Two points to put the seriousness in perspective. In the American classification of recalls, class III denotes the least severe level, the one where exposure to the product concerned is unlikely to cause adverse health consequences. And the recall was closed in July 2024, after design changes affecting both the implant and the refill needle, validated by the agency.

So why raise it, if it is settled? Because the episode illustrates a difference in kind between an injected drug and an implanted device. A syringe is used and discarded. An implant has a life cycle: it ages inside the eye, it goes through design revisions, it can be subject to recalls, and the patient carrying it is concerned by those developments for as long as they carry it. That dimension simply does not exist with an injection.

This is not an argument against the device. It is one element to weigh at the moment of choosing, alongside the number of appointments saved.

IN PRACTICE

Who might this make sense for?

No patient in France can be offered this device today, so the question is a prospective one. But it is worth asking now, because it sheds light on how to read the news.

The profile for whom the trade-off naturally falls on the right side is a patient who responds well to anti-VEGF drugs, so someone in whom the aim is not to do better but to hold steady, and in whom injections remain frequent and impossible to space out without the disease waking up. Add to that a heavy logistical load: a long journey, a carer called on every time, severe anxiety about the needle. For that person, trading twelve visits for two genuinely changes life, and the doubling of a local risk becomes a price that can be discussed.

Conversely, the calculation turns round for a patient already stable on long intervals of three or four months: the number of procedures avoided becomes small, and there is not much left to set against the additional risk. I would add a consideration that any surgeon will have in mind: an eye whose conjunctiva has already been operated on, for glaucoma in particular, offers less favourable ground for an implant placed precisely beneath that conjunctiva. These are matters of clinical judgement, not rules; formal criteria, if they ever exist in France, will be set by the authorities.

What the implant does not change

One point is often misunderstood, and it is central. Spacing out treatment does not mean spacing out monitoring. Wet AMD remains a progressive disease, capable of flaring up again. Examination of the fundus and retinal imaging keep exactly the same role: picking up renewed activity before it damages the centre of vision.

An implant can empty faster than expected, the disease can escape control, and it must then be possible to go back to injections. The Amsler grid and self-monitoring at home, one eye covered, then the other, every day, remain the rule with or without an implant. Any new distortion of straight lines, any patch appearing at the centre of vision, warrants prompt advice.

Finally, this news concerns the wet form only. It says nothing about dry AMD or about geographic atrophy, where the issues are altogether different.

THE TAKEAWAY

An advance in convenience, not in vision

The summer of 2026 has delivered three pieces of macular news in quick succession, and it is worth setting them side by side, because they are not talking about the same thing at all.

The PRIMA implant addresses the advanced dry form, geographic atrophy, in the face of which medicine had nothing to offer: it restores an ability to read where there was none left, at the cost of artificial vision and major surgery. The macular transplant performed in Turin is a one-off case, spectacular, and what it will lead to is not yet known. Susvimo, for its part, addresses the wet form, the one we already treat well: it does not set out to make people see more, it sets out to weigh less heavily.

Filing each of these announcements correctly avoids two mirror-image mistakes, equally costly. Believing that a treatment will give sight back when all it does is lighten a protocol. And, the other way round, concluding that nothing is happening because acuity does not move. For a patient of 82 who depends on her daughter for every journey, going from twelve appointments to two is not a matter of convenience: it is sometimes what decides whether treatment carries on or is abandoned, and so, indirectly, what her vision will be in five years.

The fact remains that none of this is available in France as things stand, and that the best decision a patient with AMD can take this summer has not changed: do not miss the next check-up.

FAQ

Frequently asked questions

Sources

1. European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026. Published 24 July 2026. ema.europa.eu
2. Port Delivery System Vs Monthly Ranibizumab in VEGF-Driven Macular Disease: A Systematic Review and Meta-Analysis. Semin Ophthalmol. 2026. PMID: 42360009
3. An update on the port delivery system with ranibizumab for retinal diseases. Expert Opin Drug Deliv. 2026. PMID: 41937714

Further reading

• AMD: diagnosis and treatment
• Intravitreal anti-VEGF injection: what happens on the day
• Dr Moïse Tourabaly, Ophthalmologist

Cachan practice · Tel. +33 1 45 47 08 11

Disclaimer

This article is intended for information only. A personalised ophthalmological opinion remains essential for any treatment decision.

This article describes the state of published knowledge in early August 2026 and constitutes neither a treatment proposal nor a surgical indication. At the time of writing, the opinion of the European scientific committee had not yet been followed by a decision of the European Commission, and the device is neither available nor reimbursed in France: the regulatory status should be checked with your ophthalmologist. The results quoted come from comparative trials whose averages say nothing about any individual outcome. Any decision concerning AMD is a matter for an ophthalmological opinion after examination.