Genentech, Inc., a member of the Roche Group, has received FDA approval for SUSVIMO (ranibizumab injection) 100 mg/mL to treat diabetic retinopathy (DR).
This news follows just over 3 months after the sustained-release delivery system was granted approval for wet age-related macular degeneration (AMD).
First, let’s talk about SUSVIMO.
The intravitreal (IVT) ocular implant is designed to provide a continuous delivery of a customized formulation of ranibizumab via a proprietary drug delivery system—known as the Port Delivery Platform (PDP).
- About PDP: This is a refillable ocular implant that is surgically inserted into the eye during a one-time, out-patient procedure that introduces medicine directly into the eye to treat specific vision loss-associated retinal conditions.
Give me a quick rundown on ranibizumab.
As a vascular endothelial growth factor (VEGF) inhibitor, ranibizumab is also the active ingredient in Genentech’s LUCENTIS (indicated for wet AMD, retinal vein occlusion, and DME).
How it works: In general, this anti-VEGF agent binds to and neutralizes VEGF-A (a protein that stimulates the growth of new blood vessels in the retina).
- Through this binding, ranibizumab helps to slow or stabilize vision loss in retinal diseases.
Got it. And what are Susvimo’s current indications?
- DME (as of February 2025)
- Wet AMD (as of October 2021)
The injection and delivery system are indicated for the treatment of these retinal diseases in patients who previously responded to at least two injections of a vascular endothelial growth factor (VEGF) inhibitor administered via IVT.
- And keep in mind: The drug delivery system actually made a comeback to the U.S. market last year following a near-2-year hiatus due to Genentech voluntarily recalling it.
- Read up on that here.
Let’s talk dosage.
Looking specifically at this new DR indication (via its prescribing information [PI]), Susvimo’s recommended dosage is:
- 2 mg (0.02 mL of 100 mg/mL solution in a single-dose vial) continuously delivered via the implant, with refills every 36 weeks (an estimated 9 months).
A couple of notes:
- If clinically necessary, supplemental treatment of 0.5 mg intravitreal ranibizumab injection may also be administered in the affected eye
- The initial implantation, refill exchange, and (if needed) implant removal are advised to be performed under strict aseptic conditions
How does this dosing schedule compare to its prior indications?
It’s considerably longer—and requires fewer injections for patients per year.
Case in point: While both Susvimo’s wet AMD and DME indications require the same dosage amount as the DR indication, their frequency is … more frequent.
- Refills are required every 24 weeks (an estimated 6 months)
Nice! So what clinical study was this new approval based on?
That would be 1-year data from the phase 3 Pavilion study (NCT04503551), which actually evaluated SUSVIMO for both DR and DME. See here for a look at the trial design and setup.
The primary endpoint: Number of patients with at least a two-step improvement from baseline on the Early Treatment DR Study-DR Scale (ETDRS-DRS) at Week 22.
And what did that supporting data find?
Genentech reported:
- Patients with 9-month refills of SUSVIMO achieved “superior improvements on the (Diabetic Retinopathy Severity Scale) DRSS” compared to those under monthly clinical observation
- No SUSVIMO patients required additional supplemental injections through 52 weeks (vs 60% of control-arm patients)
- SUSVIMO maintained BCVA following the expected transient postsurgical drop in vision (at Week 8), with SUSVIMO-treated patients achieving an average of +1.4-letter increase versus -2.6-letter decrease for control patients
As a bonus: Though it wasn’t included in Susvimo’s submission package, the company also reported 2-year data from Pavilion—which supported SUSVIMO’s promising safety profile and sustained efficacy demonstration. Check it out here.
Alrighty, now what safety risks and precautions should I be aware of?
As associated with Susvimo’s DME and wet AMD indications, just a few.
Click here for the full rundown.
And see common side effects associated with use here.
And what’s the big-picture significance of this approval?
As Genentech noted: “(Susvimo is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months.”
Lastly: When will this be available for DR patients?
Speak with your eyecare provider—and for those in need: check out Genentech’s patient assistant programs (and other financing options) for qualifying patients.