Retinal specialists understand the benefits of anti-VEGF injections to treat wet age-related macular degeneration can save vision and slow its progression; however, the inconvenience of visiting their office or clinic for each injection could discourage patients and lead to undertreatment.

New findings from the Vabysmo YOSEMITE and RHINE studies on diabetic macular edema as well as from Susvimo Archway study on wet AMD may enable physicians to extend the interval between injections for these diseases.

Macugen (faricimab-svoa)

Macugen (faricimab-svoa) is an intravitreal injection designed to inhibit vascular endothelial growth factor (VEGF). Studies have demonstrated its efficacy at slowing wet macular degeneration progression and decreasing choroidal neovascularization, making it one of the first injectable drugs ever shown to provide benefit in all subtypes of wet age-related macular degeneration.

VEGF inhibitors work by inhibiting VEGF-A from binding with its receptors on endothelial cells, thus decreasing vascular leakage and new blood vessel formation in the eye (1-3). FDA has approved Lucentis and its biosimilars as treatments for wet neovascular age-related macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema and myopic choroidal neovascularization.

This policy has been updated to incorporate two new products, faricimab-svoa and ranibizumab injection (Vabysmo and Susvimo), as well as our coverage position on combination VEGF/Angiopoietin-2 inhibitors such as bevacizumab/aflibercept (Eylea). Our renewal criteria for these drugs has also changed, moving away from no loss of 15 letters or more in best corrected visual acuity to improvement/maintenance or reduction of rate of vision loss.

Vabysmo (faricimab-svoa)

Vabysmo is a bispecific antibody which binds and inhibits both vascular endothelial growth factor (VEGF)-A and angiopoietin-2 (Ang-2). The FDA approved Vabysmo in January 2022 for use in treating wet age-related macular degeneration (nAMD) and diabetic macular edema (DME), with potential to help those living with these conditions achieve improved vision, as well as slow progression of their disease and delaying additional treatments such as retinal transplant or laser procedures.

The BALATON and COMINO studies were two randomized, double-masked Phase III trials designed to test the efficacy of Vabysmo for wet AMD and DME patients. Patients in each of the studies received six monthly injections of either Vabysmo or aflibercept for six months prior to transitioning onto a treat-and-extend regimen that permitted injections every four months depending on individual response.

Vabysmo demonstrated significant and sustained improvements in vision at 24 weeks in both studies. This was mainly attributed to less blood vessel leakage in the macula and faster drying of retinal fluid in his retina – both factors which helped prevent blurry vision caused by fluid build-up or swelling within his eye.

Vabysmo proved more successful at reducing retinal fibrosis than Aflibercept in treating DME, leading to significantly less frequent and severe episodes for certain individuals. This finding is especially striking when combined with its two-year post-hoc analysis: this data clearly supports it being significantly better for treating DME than Aflibercept does. Fibrosis is a natural process, yet can negatively alter eye anatomy leading to more frequent and severe attacks of DME for some patients.

Patients diagnosed with nAMD or DME should discuss their options with a retina specialist for advice tailored to each person’s individual circumstances and needs. There may also be options to help make Vabysmo more affordable regardless of health insurance provider – contact Molina to find out more information on such solutions.

Susvimo (ranibizumab injection)

Susvimo port delivery system (PDS) is an implanted surgical device that continuously delivers ranibizumab to the eye, providing patients with wet age-related macular degeneration an alternative to intravitreal injections. Every six months in doctor’s offices around the country, this PDS device is refilled with 0.1 mL of ranibizumab at 100 mg/mL dose through its special dual bore 34-gauge refill needle in aseptic conditions using task lighting, loupes and topical anesthesia as part of this procedure.

The PDS allows up to 95% of patients in Archway trial two-year data to go six months without needing a refill-exchange procedure, with few serious adverse events reported by users of the device. Additionally, studies show it was well tolerated with few serious adverse events reported as side effects.

An ophthalmologist will assess which device best fits your individual needs by performing an eye exam, optical coherence tomography (OCT), or fluorescein angiography and providing referral to a registrant specialist for implant insertion and removal procedures. At present, formal diagnosis for both wet AMD (MBS items #11219 & 11215) requires formal diagnostic angiographies; optical coherence tomography/fluorescein angiographs may also be used during initial clinical management for identification of active lesions while tracking therapy progress (MBS items #42738/2739/43741).

Current management of DME and wet AMD involves regular injections of either ranibizumab or aflibercept, administered by ophthalmologists. According to the 2018 DUSC Utilisation report, an average of 8.9 injections was given between ranibizumab and aflibercept groups with up to 13 injections being necessary in some cases.

Vabysmo YOSEMITE and RHINE studies for DME, and Susvimo Archway study for wet AMD show that individuals can be treated more frequently with less frequent eye injections. A 2-year primary analysis from Archway demonstrated this by showing that most individuals treated every six months (four-fold improvement over current average monthly injection schedule) achieved non-inferior vision outcomes when compared to high standard-of-care, monthly intravitreal injection regimen.

BEOVU (brolucizumab-dbll)

Beovu was developed by Novartis as an injection drug to treat wet age-related macular degeneration (AMD). AMD damages the macula, leading to vision loss. Beovu can help slow this decline by decreasing fluid buildup within the eye; its mechanism involves attaching and blocking an unwanted protein called vascular endothelial growth factor A (VEGF-A), thus stopping new blood vessel formation from appearing and leakage from existing vessels.

Drug studies have demonstrated the ability of this treatment to increase visual acuity for those living with wet AMD and reduce their risk of macular oedema – an eye condition where fluid accumulates on the retina, blocking sharp central vision. Macular oedema often occurs as a side effect of diabetes and, left untreated, can lead to serious vision problems and require expensive surgical intervention to correct.

BEOVU is an anti-VEGF medication and, similar to similar products, works by targeting a protein which causes blood vessels to form and leak fluid from within the eye. The active ingredient, brolucizumab, acts like an antibody which blocks VEGF-A from binding with its receptors; thus preventing new blood vessel formation as well as fluid leakage from within.

BEOVU has been shown in clinical trials to significantly slow the progression of wet AMD, compared with placebo, by 38%. Furthermore, BEOVU reduced risk for another serious eye condition called neovascular macular degeneration; which involves abnormal blood vessels growing within the eye, leading to abnormal bleeding from abnormal blood vessels forming and bleeding into it.

Medicine for intravitreal injection into the eye is administered as an outpatient procedure in most cases, though a small percentage of people may experience inflammation and retinal vasculitis symptoms; should these arise, contact your eye care provider immediately.