Oct 05, 2020
  • In a post-hoc analysis of HAWK and HARRIER, fewer Beovu (brolucizumab) patients had early persistent fluid (12.5% vs. 20.4% of aflibercept patients), defined as the presence of intra-retinal fluid and/or sub-retinal fluid through week 12 of treatment1
  • Patients with early persistent fluid treated with Beovu experienced greater gains in best-corrected visual acuity (BCVA) at week 96 versus patients treated with aflibercept (6.4 vs. 3.7 letters, respectively)1

  • This data, along with nine additional analyses of HAWK and HARRIER presented at EURETINA 2020 virtual congress, further support Beovu as an efficacious treatment option for wet AMD

Basel, October 5, 2020 — Novartis today announced that results of two new post-hoc analyses of the Phase III HAWK and HARRIER clinical trials in wet age-related macular degeneration (AMD) were presented at the EURETINA 2020 virtual congress. The first analysis demonstrated fewer Beovu® (brolucizumab) patients had early persistent fluid, defined as the presence of intra-retinal fluid and/or sub-retinal fluid through week 12 of treatment, compared with aflibercept patients1. For patients who did have early persistent fluid, those treated with Beovu achieved greater best-corrected visual acuity (BCVA) gains and greater reductions in central subfield thickness (CST) at week 96 versus those treated with aflibercept1.

A second analysis showed Beovu was associated with better control of retinal fluid, as measured by achievement and maintenance of defined CST levels. In the study, more Beovu patients than aflibercept patients achieved CST control (80% vs. 69% at week 96 at a defined CST threshold of 320 µm, respectively)2. Patients who stayed longer in a controlled CST state had better visual gains compared with those who remained in an uncontrolled CST state2. CST is a key indicator of fluid in the retina, and drying the retina is a core aim of treatment for wet AMD2.

“The data presented at EURETINA suggests Beovu can better help patients who have persistent retinal fluid achieve disease control by reducing CST and improving their vision in the long term,” said Dirk Sauer, Global Head Development, Novartis Pharma Ophthalmology. “These results further strengthen our confidence in Beovu as an effective and important treatment option for wet AMD patients aiming to improve their vision.”

Novartis has nine podium presentations at the congress and is sponsoring a Beovu symposium and an independent medical education program conducted by EURETINA.

About Beovu (brolucizumab)
Beovu (brolucizumab, also known as RTH258) is the first advanced humanized single-chain antibody fragment (scFv) approved for clinical use3-5. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics5-7.

The proprietary innovative structure results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms6. Beovu is engineered to deliver a high concentration of drug, thus providing more active binding agents3-5. In preclinical studies, Beovu inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction6-8. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema9. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions and suppress endothelial cell proliferation and vascular permeability9.

Beovu is approved in more than 40 countries, including in the US10, EU11, UK11, Japan12, Canada13 and Australia14, based on the results of the HAWK and HARRIER clinical trials.

About the HAWK and HARRIER studies
With more than 1,800 patients across nearly 400 centers worldwide, HAWK (NCT02307682) and HARRIER (NCT02434328) are the first global head-to-head trials in patients with wet AMD that prospectively demonstrated efficacy of Beovu at week 48 using an innovative q12w/q8w regimen, with a majority of patients on q12w immediately following the loading phase3,4. Both studies are 96-week prospective, randomized, double-masked multi-center studies and part of the Phase III clinical development of Beovu3,4. The studies were designed to compare the efficacy and safety of intravitreal injections of brolucizumab 6 mg (HAWK and HARRIER) and 3 mg (HAWK only) versus aflibercept 2 mg in patients with wet AMD3,4. The most common adverse events (≥5% of patients) with Beovu were vision blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye pain3,4.

Disclaimer
This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at
https://www.novartis.com.

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References

  1. Lally D. An assessment of BCVA and CST outcomes with brolucizumab and aflibercept in patients with early persistent retinal fluid: 96 week pooled data from HAWK and HARRIER. Presented at: EURETINA 2020 congress. October 2020.
  2. Singh RP, et al. Multi-State Model Analysis of Central Subfield Thickness with Brolucizumab and Aflibercept in Neovascular Age-related Macular Degeneration: 96 week pooled data from HAWK and HARRIER. Presented at: EURETINA 2020 Congress. October 2020.
  3. 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. J Ophthalmol. 2020;127(1):72-84
  4. 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]. J Ophthalmol. 2020. https://doi.org/10.1016/j.ophtha.2020.06.028.
  5. Nimz EL, et al. Intraocular and systemic pharmacokinetics of brolucizumab (RTH258) in nonhuman primates. Presented at: Association for Research in Vision and Ophthalmology (ARVO) annual meeting. 2016. Abstract 4996
  6. Escher D, et al. Single-chain antibody fragments in ophthalmology. Presented at: EURETINA congress. 2015. Abstract.
  7. Gaudreault J, et al. Preclinical pharmacology and safety of ESBA1008, a single-chain antibody fragment, investigated as potential treatment for age related macular degeneration. Invest Ophthalmol Vis Sci 2012;53:3025.
  8. 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.
  9. 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.
  10. Beovu [US prescribing information] East Hanover, NJ. Novartis: 2019.
  11. Beovu [summary of product characteristics] Basel, Switzerland. Novartis: 2020.
  12. 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.
  13. 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.
  14. Beovu [prescription medicine decision summary] Australia. Novartis: 2020.

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