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New Two-year Data Confirm Roche’s Vabysmo Improves Vision With Fewer Treatments for People With Neovascular Age-related Macular Degeneration

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New Two-year Data Confirm Roche’s Vabysmo Improves Vision With Fewer Treatments for People With Neovascular Age-related Macular Degeneration | Pharmtech Focus

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new two-year data from the TENAYA and LUCERNE studies that reinforce the long-term efficacy, safety and durability of Vabysmo® (faricimab) in neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of vision loss. 1,2 Neovascular AMD affects nearly 20 million people globally and can require treatment with eye injections every one to two months. 2,3,4 The two-year data were presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting on 14 July. 1

“These longer-term results reinforce confidence in Vabysmo and support its continued use in people with neovascular AMD,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “With the potential to require fewer injections over time, Vabysmo continues to represent an important step forward for people with vision-threatening retinal conditions, and these data exemplify our commitment to redefining standards of care and reducing treatment burden.”

In the TENAYA and LUCERNE studies, at two years:1

  • More than 60% of people receiving Vabysmo could be treated every four months – an increase of over 15 percentage points since the primary analysis at one year – while achieving comparable vision gains versus aflibercept given every two months.
  • Nearly 80% of people receiving Vabysmo could be treated every three months or longer.
  • Patients treated with Vabysmo received a median number of 10 injections over the two years versus 15 injections for those patients treated with aflibercept, potentially decreasing the number of injections.
  • Comparable reductions in central subfield thickness (CST) were observed with Vabysmo given at intervals of up to four months versus aflibercept given every two months.
  • No new safety signals were identified and Vabysmo continued to be well tolerated, with a favourable benefit-risk profile.

The primary analyses at one year formed the basis of the recent nAMD approvals in the US, Japan, the UK and several other countries around the world. Vabysmo is also approved in these countries for diabetic macular edema (DME). Vabysmo is currently under review by the European Medicines Agency for these conditions, and submissions to other regulatory authorities around the world are ongoing.

Vabysmo is the first bispecific antibody for the eye and the only injectable eye medicine approved in a number of countries for treatments up to four months apart. 4,5 Vabysmo is designed to block two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilising blood vessels, which may cause new leaky blood vessels to form and increase inflammation. 4

Detailed Two-Year Results 1
In the TENAYA and LUCERNE studies, nAMD patients received Vabysmo given at intervals of two, three or four months or aflibercept given every two months. In the second year, the dosing schedule for Vabysmo patients could be adjusted based on their response to treatment.

At two years, vision improvements were comparable across both treatment arms. In TENAYA, the average vision gains from baseline at two years were +3.7 eye chart letters in the Vabysmo arm and +3.3 letters in the aflibercept arm. In LUCERNE, the average vision gains from baseline at two years were +5.0 letters in the Vabysmo arm and +5.2 letters in the aflibercept arm.

Furthermore, 59% (n=160/271) of Vabysmo patients in TENAYA and 67% (n=192/287) in LUCERNE achieved four-month dosing at two years. This is an increase over one-year results, which showed 46% (n=144/315) of Vabysmo patients in TENAYA and 45% (n=142/316) in LUCERNE achieved four-month dosing. An additional 15% (n=41/271) of Vabysmo patients in TENAYA and 14% (n=41/287) in LUCERNE achieved three-month dosing at two years. Combined, more than 78% of Vabysmo patients were able to go three months or longer between treatments at the end of the second year.

In both studies, comparable reductions in CST were observed with Vabysmo given at intervals of up to four months versus aflibercept given every two months. Safety results were consistent across study arms, with no reported cases of retinal vasculitis or intraocular inflammation (IOI) associated with retinal vein or retinal artery occlusion.

Roche has a robust phase III clinical development programme for Vabysmo. The programme includes AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in nAMD, and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in DME. 6,7 Additionally, the COMINO and BALATON trials are also underway, evaluating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion. 8,9 Roche has also initiated the phase IV Elevatum study of Vabysmo in underrepresented patient populations with DME. 10

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