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2020-02-18| R&DTrials & Approvals

VEGF Inhibitor, Beovu Gets EC Approval for Wet Age-Related Macular Degeneration Treatment

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

Developed by Novartis, Beovu becomes the first anti-VEGF treatment of wet age-related macular degeneration to receive approval from the European Commission today. Beovu is the first EC-approved treatment to demonstrate superior resolution of retinal fluid (IRF/SRF), a key marker of disease activity in comparison to Eylea (aflibercept) developed by Regeneron. The EC approval came after the drug met the primary endpoint in Phase III HAWK and HARRIER clinical trials that demonstrated gains in best-corrected visual acuity (BCVA) when compared to aflibercept. The biggest advantage of Beovu in comparison to other drugs like Lucentis and Eylea is reduced need to visit clinics as it offers three-month dosing intervals immediately after the loading phase to eligible individuals. This is a big achievement for wet AMD treatments as more than 20 million people worldwide affected by the disease drop off existing treatments because of the frequent need to get injected.

EC commission approved the drug in all 27 European Union members as well as the UK, Iceland, Norway, and Liechtenstein. Late last year and early this year, Beovu also received FDA approval in the US, Swissmedic approval in Switzerland and TGA approval in Australia.

“Drying the retina is one of the main goals in the treatment of wet AMD with anti-VEGF therapy,” said Frank Holz, MD, FEBO, FARVO, Professor and Chairman, Department of Opthalmology, University of Bonn, Germany. “Beovu, with its superior fluid resolution as demonstrated in the HAWK and HARRIER trials, will provide physicians with a new option to treat wet AMD.”

Wet Macular Degeneration

Wet AMD or neovascular AMD is a chronic disorder that affects the eye and causes visual distortions, reduced central vision, decreased intensity of colors and a blind spot in the field of vision. It is caused by abnormal blood vessels that leak fluid or blood into the macula, a retinal area responsible for central vision. Wet AMD is a variable disease, as patients affected by this disease, not necessarily present similar symptoms. This calls for a need for a personalized treatment that achieves optimal visual outcome with minimal clinic visits and intravitreal injections. The first line of treatment for the disease includes medication like Lucentis (Ranibizumab), and Eylea (Aflibercept) that dampen the disease symptoms by blocking the growth of new blood vessels. However, treatment with these drugs requires monthly monitoring of the patient that increases the overall burden to patients, clinics and the healthcare system.

Beovu: Antibody Therapy for Wet AMD

Beovu or Brolucizumab is the humanized single-chain antibody fragment (ScFv) with a high affinity to, all VEGF-A isoforms. VEGF signaling is an important pathway to target, as it is known to cause endothelial cell proliferation and increase vascular permeability. In the retina, the wet MD progresses with an increase in VEGF, which causes increase retinal fluid accumulation and subsequently functional deterioration. By inhibiting the VEGF ligand-receptor interaction and therefore VEGF signaling, Beovu prevents pathologic ocular angiogenesis and retinal edema.

HAWK and HARRIER Trials

This was the very first global, head to head, 2 year randomized double-masked trial in patients with wet AMD that included more than 1800 patients across nearly 400 centers worldwide. Both the studies were designed to compare the efficacy and safety of intravitreal injections of brolucizumab 6mg (HAWAK and HARRIER) and 3mg (only HAWK) with aflibercept 2mg in patients with wet AMD. After injections at 0,4, and 8 weeks (loading phase), brolucizumab was injected every 12 weeks (q12w) unless disease activity was identified, resulting in a permanent adjustment to injections every 8 weeks (q8w). Aflibercept was injected q8w as per the label at the time of study initiation.

Collectively known as q12w/q8w, this regimen was used to determine the efficacy of the ScFv against aflibercept. The study demonstrated noninferiority to aflibercept in BCVA change from baseline at week 48. Vision gains at year one were maintained at year two. In additional secondary endpoints, Beovu worked better than aflibercept. A significantly less number of patients had intra-retinal/sub-retinal fluid (IRF/SRF), which is a good sign of recovery as these fluids cause damage to the macula (31% for 6 mg brolucizumab vs 45% for alibercept in HAWK on the first year). Beovu also improved central subfield thickness, another indicator of retinal fluid on week 16 and completion of one year. In both the trials, 30% fewer patients had signs of disease activity with Beovu when compared to aflibercept as early as week 16.

“Today’s approval is a step forward for patients in Europe who have been looking for a new treatment option which may help them maintain their sight and their independence for longer,” said Christina Fasser, President, Retina International. “This can really help to alleviate a burden, not only on the patient themselves, but also on those who care for them.”

Related Article: FDA Greenlights Tepezza as First Treatment for Thyroid Eye Disease

References

  1. Beovu [summary of product characteristics] Basel, Switzerland. Novartis: 2020.
  2. Dugel P, Koh A, Ogura Y, et al; HAWK and HARRIER Study Investigators. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127(1):72-84.
  3. https://www.novartis.com/news/media-releases/novartis-receives-ec-approval-beovu-next-generation-anti-vegf-treatment-wet-amd-leading-cause-blindness-worldwide

 

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