Genentech, Inc., a member of the Roche Group, has received FDA approval for SUSVIMO (ranibizumab injection) 100 mg/mL to treat diabetic macular edema (DME).
This marks the second indication for the first sustained-release drug delivery system, which was originally approved in 2021 for wet age-related macular degeneration (AMD).
Let’s get some details on SUSVIMO.
Designed as an intravitreal (IVT) ocular implant—and previously referred to as the Port Delivery System—SUSVIMO provides ongoing delivery of a customized formulation of ranibizumab via a proprietary drug delivery system.
A note about ranibizumab: This vascular endothelial growth factor (VEGF) inhibitor is also the active ingredient in Genentech’s LUCENTIS, which was approved in 2006 and already indicated for wet AMD, retinal vein occlusion (RVO), and DME.
Got it. And its indication?
SUSVIMO is indicated for the treatment of DME (and wet AMD, but more on that below) in patients who previously responded to at least two IVT injections of a VEGF inhibitor medication.
According to its prescription information (PI), its recommended dosage includes:
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)
- Note: If clinically necessary, supplemental treatment of 0.5 mg intravitreal ranibizumab injection may also be administered in the affected eye.
Can I get a visual of how this works?
You bet. Watch a video of how the drug delivery system works here.
Talk about this initial wet AMD indication for a moment.
That October 2021 wet AMD-indicated approval of the SUSVIMO injection and accompanying ocular implant was later followed by Genentech issuing a voluntary recall.
What this included: The initial fill kit and not (most notably) the actual ranibizumab injection or refill needle. See details on that situation (and the reason for the recall) here.
And didn’t the company also announce plans for a reintroduction?
They did! In July 2024, Genentech announced it would be bringing SUSVIMO back to the U.S. market after making updates to (and conducting testing on) the delivery system.
- Since then, the wet AMD treatment is now available.
Now circling back to this DME indication. What clinical data is it based on?
One-year findings from the multicenter, randomized, active treatment-controlled, non-inferiority phase 3 PAGODA study (NCT04108156).
A brief overview: The trial evaluated the safety, efficacy, and pharmacokinetics of SUSVIMO when refilled every six months compared to monthly IVT ranibizumab 0.5 mg injections.
- The participants: 634 DME patients randomized 3:2 to receive either SUSVIMO or ranibizumab
- A note about the SUSVIMO arm: Four loading doses of ranibizumab were administered before SUSVIMO implantation at Week 16
- The outcome measure: Change in best-corrected visual acuity (BCVA) score from baseline at the average of Weeks 60 and 64. See here for all primary outcome measures.
And what were the findings?
Positive one-year data found SUSVIMO to demonstrate “sustained vision improvements in DME patients” along with "safety consistent with the known safety profile for SUSVIMO.”
Specifically: Patients with 6-month refills of SUSVIMO achieved non-inferiority visual acuity (VA) gains vs those receiving monthly 0.5 mg ranibizumab IV injections
- The numbers: 9.6 eye chart letters, similar to gaining two more lines on an eye chart, compared to 9.4 letters, respectively
Further: 95% of SUSVIMO patients didn’t need additional supplemental injections through Week 64.
Nice! And wasn’t there actually 2-year data from the study as well?
Good memory! In July 2024 (just after announcing its plans for a SUSVIMO wet AMD relaunch), Genentech reported positive phase 3 data from the Pagoda trial along with the Pavilion trial, which evaluated SUSVIMO for diabetic retinopathy (DR).
The DME-focused findings: SUSVIMO continued to demonstrate sustained efficacy over 2 years along with a promising safety profile.
- See here for the numbers.
Amazing! Now I have to ask: Are there any precautions or safety risks to be aware of with this?
A few … based on clinical investigation, the SUSVIMO implant and / or other related procedures have been associated with:
- Endophthalmitis
- Rhegmatogenous retinal detachment
- Implant dislocation
- Septum dislodgement
- Vitreous hemorrhage
- Conjunctival erosion
- Conjunctival retraction
- Conjunctival blebs
See SUSVIMO’s PI for further details on these potential ocular events.
Duly noted. Now, what’s the significance of this approval?
As Genentech has noted, SUSVIMO is now the first and only FDA-approved treatment to provide continuous treatment and maintain vision in DME patients with fewer injections (just two refills per year) than standard eye injections.
See here for how it compares to other retinal disease treatments.
And lastly: When will this be available for my patients?
Click here to learn more.