Novartis reports positive topline results from the first Phase III trial of Beovu versus aflibercept in patients with diabetic macular edema (DME)
Sep 14, 2020
- In Phase III KITE study, Beovu (brolucizumab) 6 mg achieved its primary endpoint of non-inferiority to aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52)1
- In a key secondary endpoint, more than half of Beovu patients were maintained on a three-month dosing interval through year one, following the loading phase1
- Beovu showed superior improvement versus aflibercept in change of central subfield thickness, a secondary endpoint, over the period of week 40 through week 521
- Beovu demonstrated an overall well-tolerated safety profile comparable to aflibercept; in addition the rate of intraocular inflammation was equivalent between Beovu and aflibercept1
- Novartis actively progressing full clinical development program of Beovu, with studies across wet AMD, DME, retinal vein occlusion and proliferative diabetic retinopathy
- Novartis data on file. September 2020.
- ClinicalTrials.gov. Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema (KESTREL).?https://clinicaltrials.gov/ct2/show/NCT03481634. Accessed September 2020.
- Leasher JL, et al. Global Estimates on the Number of People Blind or Visually Impaired by Diabetic Retinopathy: A Meta-Analysis from 1990 to 2010. Diabetes Care. 2016;39:1643-9.
- Romero-Aroca P. Managing diabetic macular edema: The leading cause of diabetes blindness. World J Diabetes. 2011;2(6):98-104. doi:10.4239/wjd.v2.i6.98.
- National Eye Institute. Diabetic Retinopathy. Available at:?https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/diabetic-retinopathy. Accessed August 2020.
- National Eye Institute. Macular Edema. Available at:?https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema#section-id-1556. Accessed August 2020.
- Beovu [US prescribing information] East Hanover, NJ. Novartis: 2019
- Beovu [summary of product characteristics] Basel, Switzerland. Novartis: 2020.
- Pharma Japan. National Health Insurance Pricing. Available at:?https://pj.jiho.jp/sites/default/files/pj/document/2020/05/New%20Drugs%20to%20Be%20Added%20to%20NHI%20Price%20List%20on%20May%2020_1.pdf. Accessed September 2020.
- Canadian Agency for Drugs and Technologies in Health. CADTH Canadian Drug Expert Committee Recommendation. Available at:?https://cadth.ca/sites/default/files/cdr/complete/SR0632%20Beovu%20-%20CDEC%20Final%20Recommendation%20%E2%80%93%20May%2025%2C%202020_for%20posting.pdf. Accessed September 2020.
- Beovu [prescription medicine decision summary] Australia. Novartis: 2020.
- 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
- Dugel PU, Singh RP, Koh A, et al. HAWK and HARRIER: 96-Week outcomes from the phase 3 trials of brolucizumab for neovascular age-related macular degeneration [published online ahead of print]. Ophthalmology. 2020.?https://doi.org/10.1016/j.ophtha.2020.06.028.
- Nimz EL, et al. Intraocular and systemic pharmacokinetics of brolucizumab (RTH258) in nonhuman primates. The Association for Research in Vision and Ophthalmology (ARVO) annual meeting. 2016. Abstract 4996
- Escher D, et al. Single-chain antibody fragments in ophthalmology. Oral presentation at EURETINA congress. 2015. Abstract.
- Gaudreault J, et al. Preclinical pharmacology and safety of ESBA1008, a single-chain antibody fragment, investigated as potential treatment for age related macular degeneration. ARVO Annual Meeting abstract. Invest Ophthalmol Vis Sci 2012;53:3025.?http://iovs.arvojournals.org/article.aspx?articleid=2354604?(link is external). Accessed February 2020
- Tietz J, et al. Affinity and Potency of RTH258 (ESBA1008), a Novel Inhibitor of Vascular Endothelial Growth Factor A for the Treatment of Retinal Disorders. IOVS. 2015; 56(7):1501.
- Kim R. Introduction, mechanism of action and rationale for anti-vascular endothelial growth factor drugs in age-related macular degeneration. Indian J Ophthalmol. 2007;55(6):413-415.
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Novartis Media Relations E-mail:?media.relations@novartis.comPeter Zuest Novartis External Communications + 41 79 899 9812 (mobile) peter.zuest@novartis.com Eric Althoff Novartis US External Communications +1 646 438 4335 eric.althoff@novartis.com | Amy Wolf Novartis Division Communications + 41 61 696 58 94 (direct) + 41 79 576 07 23 (mobile) amy.wolf@novartis.com |
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