Genentech, a member of the Roche Group, released new 5-year efficacy, safety, and durability findings on SUSVIMO (ranibizumab injection) for the treatment of wet age-related macular degeneration (AMD).
The results were reported during the American Society of Retina Specialists (ASRS) 2025 annual meeting in Long Beach, California, over the weekend.
Right off the bat: Start with SUSVIMO.
Already FDA-approved (we’ll get to that in a moment), the intravitreal (IVT) ocular implant is designed to provide a continuous delivery of a customized formulation of 100 mg/mL ranibizumab (FDA-approved in 2006) via a proprietary drug delivery system: the Port Delivery Platform (PDP).
- About PDP: This refillable ocular implant is surgically inserted into the eye during a one-time, outpatient procedure that treats specific vision loss-associated retinal conditions.
And this brings us to … its approved indications?
Indeed it does. The medication is currently approved for:
- Wet AMD (as of October 2021, though it was relaunched in the U.S. last year after a voluntary recall)
- Diabetic macular edema (DME; as of February 2025)
- Diabetic retinopathy (DR; as of May 2025)
A word on these: SUSVIMO and PDP are intended for use in patients who previously responded to at least two injections of a vascular endothelial growth factor (VEGF) inhibitor administered via IVT.
Noted. So what does its dosing schedule look like?
Per SUSVIMO’s prescribing information (PI): 2 mg (0.02 mL of 100 mg/mL solution in a single-dose vial) continuously delivered via the implant, with refills every:
- 24 weeks (an estimated 6 months) for wet AMD and DME
- See how this compares to other wet AMD treatments
- 36 weeks (an estimated 9 months) for DR
And take note: A supplemental treatment of 0.5 mg intravitreal ranibizumab injection may also be administered in the affected eye, if clinically necessary.
Any warnings and precautions associated with its use?
Of course. Check them out.
Now to this phase 3 study of interest.
As we mentioned, the 5-year findings are reserved for SUSVIMO’s wet AMD indication.
The clinical study: The Portal study, a long-term, open-label extension of the phase 3 Archway trial (NCT03677934)—whose results supported its 2021 FDA approval.
A few details on that original Archway study:
- The purpose: To determine the efficacy and safety of SUSVIMO refilled every 6 months at fixed intervals versus ranibizumab, IVT-injected on a monthly basis
- The design: Randomized, multicenter, open-label
- The participants: 415 patients (aged 50+) diagnosed with wet AMD
- The setup: Patients randomized 3:2 to either:
- SUSVIMO (n = 248)
- Ranibizumab (n = 167)
- The outcome measures:
- Primary: Change in best-corrected visual acuity (BCVA) from baseline at the average of Weeks 36 and 40
- Secondary: Safety, overall change in BCVA from baseline, and change from baseline in center point thickness
And how did the open-label extension compare?
A total of 352 participants from the Archway trial who were originally treated with SUSVIMO continued on to the Portal study.
- Cohort 1: 220 patients continued to receive SUSVIMO (refilled every 6 months)
- Cohort 2: 132 patients originally treated with monthly IVT ranibizumb injections received SUSVIMO (also refilled every 6 months)
So what was found at the 5-year mark?
In general: The company reported that SUSVIMO’s immediate and predictable durability was sustained over the 5-year period, with "approximately 95% of people receiving treatment every six months requiring no supplemental treatment before each refill.”
- Also noted: “Consistent and sustained disease control and retinal drying” among patients, with “vision at or near peak levels after receiving an average of five (IVT) injections.”
Break the data down by cohort.
Looking at vision gains:
- For Cohort 1 (SUSVIMO-injected patients):
- BCVA: 74.4 letters at baseline vs 67.6 letters at 5 years
- For Cohort 2 (ranibizumab-to-SUSVIMO-injected patients):
- BCVA: 76.3 at baseline vs 68.6 letters at 5 years
“Half of all patients had better than 20/40 vision at 5 years (Snellen visual acuity test),” according to Genentech.
And how did central subfield thickness fare?
The average CST remained stable—with a reduction from baseline noted for both cohorts.
- Cohort 1 (SUSVIMO-injected patients):
- CST: 1.4 (95% Confidence interval [CI]: -13.1, 11.1) µm reduction
- Cohort 2 (ranibizumab-to-SUSVIMO-injected patients):
- CST: 4.2 (95% CI: -25.7, 5.0) µm reduction
What else to know?
The company emphasized that the Portal study’s participants are “the largest cohort of people with wet AMD to be followed prospectively and continuously for 5 years in a clinical study.”
Impressive. So what does all of this mean?
Levi Garraway, MD, PhD, Genentech’s chief medical officer, stated that the long-term findings reinforce SUSVIMO’s “unique therapeutic approach” in offering an alternative treatment to regular eye injections—all while "preserving vision in a sustained manner.”