-- Beovu (brolucizumab) met MERLIN's primary endpoint of non-inferiority in 
      change in best corrected visual acuity from baseline and superiority on 
      anatomical secondary endpoints at year one versus aflibercept when given 
      every four weeks following the loading phase1 
 
   -- In this study evaluating every four week dosing, Beovu was associated 
      with higher rates of IOI including retinal vasculitis and retinal 
      vascular occlusion versus aflibercept1 
 
   -- Patient safety is of paramount importance and led Novartis to decide on 
      early termination of the MERLIN study 
 
   -- Novartis has also decided on early termination of the RAPTOR and RAVEN 
      studies, which assessed the efficacy and safety of brolucizumab in 
      retinal vein occlusion, and included six initial monthly injections 
 
   -- Novartis has proactively communicated these data to health authorities 
      and will pursue an update to the Beovu prescribing information globally 
      regarding every four week dosing 
 
   -- When used on a two- to three-month interval following the loading phase, 
      Beovu remains an important and effective treatment option for appropriate 
      patients with wet AMD2,3 
 
 
   Basel, May 28, 2021 -- Today, Novartis reported the first interpretable 
year one results of the Phase III MERLIN study, a two-year study 
initiated in H2 2018, assessing the efficacy and safety of Beovu(R) 
(brolucizumab) 6 mg versus aflibercept 2 mg given every four weeks 
following the loading phase in patients with wet age-related macular 
degeneration (AMD) who have persistent retinal fluid despite anti-VEGF 
therapy. 
 
   Beovu met MERLIN's primary endpoint of non-inferiority in change in best 
corrected visual acuity from baseline and superiority on select 
anatomical secondary endpoints at year one versus aflibercept when given 
every four weeks following the loading phase(1) . However, given every 
four weeks in MERLIN, IOI including RV, and RO were reported with a 
higher frequency in the Beovu 6 mg every four weeks arm when compared to 
aflibercept 2 mg every four weeks (IOI: 9.3% vs 4.5% of which RV: 0.8% 
vs 0.0%; RO: 2.0% vs 0.0%.)(1) . The overall rate of vision loss (15 
letters or more) due to all causes was 4.8% in the Beovu arm and 1.7% in 
the aflibercept arm(1) . 
 
   "Although longer dosing intervals may benefit many people living with 
wet AMD and other retinal diseases, some are in need of monthly dosing 
to address persistent fluid. We initiated MERLIN and other clinical 
programs to explore Beovu for these patients," said John Tsai, MD, 
Global Head of Drug Development and Chief Medical Officer, Novartis. 
"These data help inform our trials moving forward, so we can best 
determine how appropriate patients can benefit most from this important 
medicine." 
 
   Novartis evaluated all ongoing brolucizumab clinical programs assessing 
studies with four week dosing intervals after the loading phase. In the 
interest of patient safety, Novartis has decided to terminate the MERLIN 
study and the RAPTOR and RAVEN studies, which were assessing the 
efficacy and safety of brolucizumab with six initial monthly injections 
in retinal vein occlusion. All other relevant ongoing trial protocols 
will be amended to discontinue four week dosing intervals after the 
loading phase. Clinical trial investigators have been informed and will 
appropriately follow up with their patients. Physicians should not treat 
patients with Beovu 6 mg at intervals less than two months beyond the 
first three doses. 
 
   Novartis has proactively communicated these data to health authorities 
and will pursue an update to the Beovu prescribing information globally. 
 
 
   When used on a two- to three-month interval following the loading phase, 
Beovu continues to be an important and effective treatment option for 
appropriate patients with wet AMD(2,3) . Novartis remains committed to 
supporting the retina community with information regarding Beovu. Beovu 
is contraindicated in patients with ocular or periocular infections, 
active intraocular inflammation or known hypersensitivity to 
brolucizumab(4) . 
 
   Further analysis of the clinical data from MERLIN is ongoing, and 
detailed data will be presented at an upcoming medical meeting. Novartis 
has a strong ongoing commitment to Ophthalmology and to bringing 
innovative treatments to patients with or at risk of developing eye 
conditions where there is a high unmet need. 
 
   About wet AMD 
 
   Wet AMD is the leading cause of severe vision loss and legal blindness 
in people over the age of 65 in North America, Europe, Australia and 
Asia, impacting an estimated 20 million people worldwide(5-7) . Wet AMD 
occurs when abnormal blood vessels form underneath the macula, the area 
of the retina responsible for sharp, central vision(8-10) . These blood 
vessels are fragile and leak fluid, disrupting the normal retinal 
architecture and ultimately causing damage to the macula(8-10) . 
 
   Early symptoms of wet AMD include distorted vision (or metamorphopsia) 
and difficulties seeing objects clearly(11) . Prompt diagnosis and 
intervention are essential. As the disease progresses, cell damage 
increases, further reducing vision quality(1) (2) . This progression can 
lead to a complete loss of central vision, leaving the patient unable to 
read, drive or recognize familiar faces and potentially depriving them 
of their independence(12,13) . Without treatment, vision can rapidly 
deteriorate(1) (4) . 
 
   About Beovu (brolucizumab) 
 
   Beovu (brolucizumab, also known as RTH258) is approved for the treatment 
of wet age-related macular degeneration (AMD) in more than 60 countries, 
including in the US, EU, UK, Japan, Canada and Australia(4,15-18) . 
Additional trials, which study the effects of brolucizumab in patients 
with wet AMD, diabetic macular edema (DME), and proliferative diabetic 
retinopathy (PDR), are currently ongoing. 
 
   About Novartis in Ophthalmology 
 
   At Novartis, our mission is to discover new ways to improve and extend 
people's lives. In ophthalmology, we develop and deliver life-changing 
medicines and therapies for diseases and conditions from front to back 
of the eye, enabled by data and transformative technologies. Our 
ophthalmic solutions reach more than 150M people per year, from 
premature infants to the elderly. 
 
   Disclaimer 
 
   This press release contains forward-looking statements within the 
meaning of the United States Private Securities Litigation Reform Act of 
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providing the information in this press release as of this date and does 
not undertake any obligation to update any forward-looking statements 
contained in this press release 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 110,000 people of more than 140 nationalities work at 
Novartis around the world. Find out more at https://www.novartis.com. 
 
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May 28, 2021 16:30 ET (20:30 GMT)