Duravyu (vorolanib intravitreal insert)

Wet (neovascular) age-related macular degeneration (AMD) is the late neovascular form of AMD. The AAO estimates that about 80% of people with AMD have the non-neovascular form, yet the neovascular form accounts for nearly 90% of severe visual acuity loss (20/200 or worse) from AMD. The estimated annual incidence of neovascular AMD in White US adults aged 50 years or older is 1.8 per 1,000, and an estimated 168,400 people in the United States had new-onset neovascular AMD in 2018. In 2019, an estimated 1.49 million US adults aged 40 years or older (crude prevalence 0.94%) had late-stage AMD (choroidal neovascularization and/or geographic atrophy); globally, 196 million people were projected to have AMD in 2020 and 288 million in 2040.

Without treatment, eyes lose a mean of 2.7 lines of visual acuity by 12 months and 4 lines by 24 months, and the proportion with visual acuity worse than 20/200 rises from 19.7% at baseline to 75.7% by 3 years. With anti-VEGF therapy, scar developed in 480 of 1,059 eyes (45.3%) by 2 years in CATT, and in routine US practice the mean visual acuity gain at 1 year was 0.95 letter after a mean of 7.3 injections.

The humanistic burden includes depressive symptoms in 42.04% of 547 participants presenting for treatment (CES-D-10) and time trade-off utility values that fall from 0.89 at 20/20 to 20/25 to 0.40 at counting fingers to light perception in the better-seeing eye. The economic burden is concentrated in intravitreal anti-VEGF drugs: 2024 Medicare Part B spending, across all indications, was $2.37 billion for aflibercept 2 mg, $1.92 billion for faricimab, and $0.67 billion for aflibercept 8 mg. Mean annual societal ophthalmic costs were $39,910 in participants with visual loss compared with $6,116 in those with good vision, and direct nonmedical costs, primarily caregiver costs, made up 67.1% of the costs in participants with visual loss. Each treatment visit took a mean of 90 minutes in clinic and almost 12 hours including travel and recovery, 24.8% of caregivers in a UK survey required time off work, and 11.6% of treated participants in the IRIS Registry were lost to follow-up within 12 months.