New 2-year data supports faricimab-svoa for treatment of wet AMD

New 2-year data from the TENAYA and LUCERNE studies confirm the long-term efficacy, safety, and durability of faricimab svoa (Vabysmo) for the treatment of neovascular age-related macular degeneration (wet AMD), Genentech announced Thursday.

According to a news release on the data —which was presented at the 2022 American Society of Retina Specialists (ASRS) annual scientific meeting— highlights from both trials include:

• More than 60% of participants receiving faricimab-svoa could be treated every 4 months (which was an increase of 15 percentage points since the primary analysis at 1 year) while achieving comparable vision gains versus aflibercept given every 2 months.
• Nearly 80% of patients receiving faricimab-svoa could be treated every 3 months or longer.
• Patients treated with faricimab-svoa received a median number of 10 injections over 2 years versus 15 injections for those who were treated with aflibercept (potentially decreasing the number of injections.
• Comparable reductions in central subfield thickness (CST) were observed with faricimab-svoa given at up to 4-month intervals versus aflibercept given at 2-month intervals.
• No new safety signals were identified; faricimab-svoa continued to be well tolerated with a favorable benefit-risk profile.
  

Faricimab-svoa is the first bispecific antibody for the eye as well as the only injectable eye medicine approved by the FDA with the option for treatments from 1 to 4 months apart in the first year after 4 initial monthly loading doses, according to the release.

In both studies, patients diagnosed with wet AMD received faricimab-svoa at intervals of either 2, 3, or 4 months, or were given aflibercept every 2 months. In year 2 of the studies, the dosing schedule patients who received faricimab-svoa could be adjusted based on their response to treatment.

Additionally, vision improvements were comparable across both treatment arms at 2 years.

In TENAYA, the average vision gains from baseline at 2 years were +3.7 eye chart letters in the arm with faricimab-svoa and +3.3 letters in the aflibercept arm.

In LUCERNE, the average vision gains from baseline at 2 years were +5.0 letters in the faricimab-svoa arm and +5.2 letters in the aflibercept arm, according to the release.

Other reported data include:

59% (n=160/271) of faricimab-svoa patients in TENAYA and 67% (n=192/287) in LUCERNE achieved 4-month dosing at 2 years— an increase over 1-year results, which showed 46% (n=144/315) of faricimab-svoa patients in TENAYA and 45% (n=142/316) in LUCERNE achieved 4-month dosing.

An additional 15% (n=41/271) of faricimab-svoa patients in TENAYA and 14% (n=41/287) in LUCERNE achieved 3-month dosing at 2 years. In total, more than 78% of faricimab-svoa patients were able to go 3 months or longer between treatments at the end of the second year.

Further, comparable reductions in central subfield thickness were observed with faricimab-svoa given at intervals of up to 4months versus aflibercept given every 2 months in both studies.

Lastly, there were consistent safety results across study arms, with no reported cases of retinal vasculitis or intraocular inflammation that were associated with retinal vein or retinal artery occlusion, the release stated.