RANIBIZUMAB INJ,SOLN
Clinical Criteria Summary
Indication & Patient Population
- Treatment of neovascular age-related macular degeneration (nAMD)
- Previously responded to at least two intravitreal injections of a VEGF inhibitor
- Age 50 years or greater
- nAMD-related neovascular lesions involving the macula diagnosed within 9 months of screening
- At least 3 prior VEGF inhibitor intravitreal injections within 6 months of screening with anatomical and visual response
Dosing & Administration
- 100 mg/mL solution for intravitreal use via SUSVIMO ocular implant
- Recommended dose: 2 mg (0.02 mL) continuously delivered via the implant with refills every 24 weeks (approximately 6 months)
- Supplemental treatment with 0.5 mg intravitreal ranibizumab injection may be administered in the affected eye if clinically necessary
Contraindications & Safety Warnings
- Ocular or periocular infection
- Active intraocular inflammation
- Hypersensitivity to ranibizumab or excipients in SUSVIMO
- Boxed warning for 3-fold higher rate of endophthalmitis compared to monthly intravitreal injections
Procedural & Monitoring Requirements
- Implant and refill procedure must be performed under strict aseptic conditions by an ophthalmologist experienced in vitreoretinal surgery
- Temporarily discontinue antithrombotic medication prior to implant insertion procedure to reduce risk of vitreous hemorrhage
- Close monitoring required due to frequency of adverse events and to assess need for supplemental IVT ranibizumab
- Patients instructed not to push on, rub, or touch the eye/implant area for 30 days following implant surgery and refill-exchange procedure; avoid rubbing/touching throughout treatment
Place in Therapy / Reserve Criteria
- Reserved for patients with nAMD who have demonstrated response to VEGF inhibitors and who would benefit from reducing treatment burden (e.g., long travel times, physical mobility limitations)