Current treatments for wet age-related macular degeneration involve blocking vascular endothelial growth factor, or VEGF, with monthly injections into the eye to stop new blood vessels from forming in the retina. A recent study suggests that some individuals may be able to forgo monthly injections altogether.

Nancy Lurker from EyePoint Pharmaceuticals presented 12-month safety results from the DAVIO trial examining EYP-1901 vorolanib for use in neovascular AMD. This bioerodible implant provides a safe and effective alternative to injecting ranibizumab.

Vabysmo

Vabysmo was approved in January 2022 as the first bispecific antibody treatment for macular edema caused by retinal vein occlusion. It can also help treat wet age-related macular degeneration (nAMD) and diabetic macular edema (DME), among other conditions linked to retinal disease by inhibiting two disease pathways involving angiopoietin-2 and vascular endothelial growth factor-A (VEGF-A).

Vabysmo received FDA approval based on data from two phase 3 randomized, double-masked studies: BALATON and COMINO trials that demonstrated faricimab-svoa’s effective retinal drying properties in patients suffering from neovascular AMD or DME, along with early and sustained improvements in best corrected visual acuity after one year compared with Aflibercept. Both trials met their primary endpoint of non-inferiority at one year for change from baseline in BCVA change from baseline compared with Aflibercept at this stage of study.

Rahul Khurana, MD, from University of Southern California in Los Angeles and colleagues recently published an analysis of real-world data regarding Vabysmo use in treating neovascular age-related macular degeneration. They conducted this multicenter retrospective chart review study from February to September 2022 using patients treated with anti-VEGF agents for this condition; data collection included demographic information, treatment history changes from baseline in best-corrected visual acuity levels as well as anatomic changes as safety markers.

The authors found that patients receiving Vabysmo were less likely to develop new macular edema at week four compared to those taking Aflibercept, possibly as a result of its inhibitory properties against Ang-2/VEGF-A signaling pathways. Furthermore, this research indicates that those requiring frequent treatments with anti-VEGF drugs could potentially benefit from switching over to Vabysmo as an anti-VEGF alternative.

Susvimo’s YOSEMITE and RHINE studies revealed that 60% of individuals eligible for every-four-month dosing could go six months between treatments, an improvement over Archway’s four month dosing interval. More research must be conducted in order to understand whether these results apply in reality – optical coherence tomography evaluations will play an essential part in this assessment process.

Susvimo

Susvimo is a six-month refillable implant designed to deliver ranibizumab continuously to treat wet age-related macular degeneration (AMD). The drug works by inhibiting vascular endothelial growth factor (VEGF), which contributes to new blood vessel formation that leak fluid, leading to progressive loss of central vision. Susvimo was approved by the FDA last year on two year results of Archway study where it was compared with monthly ranibizumab injections as treatments for treating wet AMD in people who had responded well to at least two anti-VEGF treatments before.

Study results demonstrated that 95% of patients could go six months without needing implant treatment; in some instances however, such as retinal tears or serious complications arising, implants were removed for safety reasons; during the course of this research study there were no instances of severe vision loss or vitreous hemorrhage (vitreous hemorrhage). Susvimo’s safety and efficacy have also been demonstrated through its participation in three additional studies; two-year data from all three will be presented at Angiogenesis meeting before going commercial availability across Europe next year.

Medicare Benefits Schedule has been amended to cover implantation, initial fill, refill-exchange and explantation procedures of ranibizumab (Susvimo; Roche/Genentech). Wet age-related macular degeneration is caused by abnormal blood vessels that leak blood into the macula and results in blindness; it is a major cause in America among older people.

Many medications exist to slow the progression of wet macular degeneration, including injectable medications such as Aflibercept (Eylea; Regeneron) and Bevacizumab (Avastin; Genentech). A recently approved therapy called Susvimo from Genentech/Roche can also help slow progression; its delivery by way of an implant surgically placed in one eye can reduce injection frequency while potentially cutting costs; yet whether this approach will actually result in improved vision outcomes is yet unknown but certainly it seems promising.

Aflibercept

Aflibercept is an anti-angiogenic drug which inhibits blood vessel formation and decreases fluid accumulation in the area of sharpest vision, the macula. Neovascular (or wet) AMD occurs when blood vessels leak fluid that creates blurry spots or blind spots at the centre of your vision, leading to central vision loss in its wake. Aflibercept works by blocking VEGF, an important protein which causes blood vessels to form in the retina, thus increasing quality of life and decreasing risks of vision loss. Studies have proven its efficacy. At first, injections will be given intravitreally every month before slowly increasing to every eight weeks as soon as treatment shows promise for each patient. Repeated injections can prevent further vision loss but can become burdensome to some individuals; doctors attempt to lengthen or shorten injection schedules depending on how successful treatment has been for individual patients.

It may be considered experimental at present and research results remain limited; nevertheless, their preliminary evidence base appears encouraging. In the phase 3 VIEW 2 clinical trial conducted with patients suffering from neovascular wet AMD who received monthly injections of either Aflibercept or Ranibizumab showed non-inferiority in terms of best corrected visual acuity (BCVA) and central macular thickness (CMT), when compared to standard care patients.

PULSAR and PHOTON trials for DME/wet AMD are double-masked, active-controlled pivotal trials which compare aflibercept to laser treatment in multiple sites around the world and should be completed by 2023. They will establish the maximum safe dose for this drug while testing whether or not it improves vision.

Bayer has accepted the PBAC decision and looks forward to releasing Aflibercept onto the Australian market, though they are disappointed at being restricted only for treatment-naive patients. Bayer will work constructively with PBAC in order to address this issue and open access for those who have previously received therapy. Patients should be aware of any associated risks during intravitreal injection procedures – endophthalmitis and retinal detachment can occur; proper aseptic technique must be adhered to throughout this procedure.

Lytenava

Outlook Therapeutics was issued a complete response letter (CRL) by the Food and Drug Administration regarding ONS-5010/Lytenava, its investigational bevacizumab eye injection for wet age-related macular degeneration. They are currently working to address their CRL. If approved, this product would become the first ever ophthalmic formulation of bevacizumab ever on the market – replacing existing off-label compounded bevacizumab products that currently exist off-label compounded versions currently in circulation.

Studies conducted to date indicate that intravitreal Aflibercept is effective at preventing progression to advanced exudative AMD among high-risk eyes with intermediate dry AMD. Furthermore, its findings support the hypothesis that anti-vascular endothelial growth factor agents may protect aging eyes against disease progression.

Researchers also studied how SD-OCT could detect primary open angle glaucoma (POAG) progression using SD-OCT, and discovered that GCC thinning predicted functional loss more reliably than retinal nerve fiber layer (RNFL) thinning among glaucoma patients; although RNFL thinning is linked with more severe cases and may predict surgery; the study did not investigate why this difference existed or whether its source lies elsewhere; for example in treatment methods or baseline characteristics of study population members.