Novartis presents new data at EURETINA 2017 confirming Lucentis® efficacy and durability vs aflibercept
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Novartis International AG /
Novartis presents new data at EURETINA 2017 confirming Lucentis® efficacy and
durability vs aflibercept
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* Interim results of the head-to-head RIVAL study confirm strong efficacy and
comparable durability versus aflibercept in patients with nAMD
* Five-year results from the Lucentis LUMINOUS study, the largest ever in
retinal disease, demonstrate real-world efficacy and safety across five
retinal diseases
Basel, September 09 2017 - Novartis, the global leader in ophthalmology, today
reported new data confirming Lucentis(®) (ranibizumab) efficacy and durability
in patients with nAMD at the 17(th) EURETINA Congress in Barcelona, Spain
(September 7-10, 2017). One-year interim results from the Phase IV head-to-head
RIVAL study compared ranibizumab versus aflibercept using a treat-and-extend
treatment regimen in patients with neovascular age-related macular degeneration
(nAMD).
Additionally, five-year results from the LUMINOUS study confirm the real-world
efficacy and safety of Lucentis in patients with nAMD, visual impairment due to
diabetic macular edema, branch retinal vein occlusion, central retinal vein
occlusion and myopic choroidal neovascularization. LUMINOUS is a real-world
study assessing the long-term effects of Lucentis in more than 30,000 patients
being treated across five different eye diseases in 43 countries across 494
sites, making this the largest-ever study in retinal disease. This data deepens
our knowledge of how the product is being used by patients in the real world.
"We are delighted by the RIVAL data, which confirms unsurpassed efficacy of
Lucentis," said Vas Narasimhan, Global Head, Drug Development and Chief Medical
Officer, Novartis. "Both RIVAL and LUMINOUS demonstrate our commitment to
further invest in the science of this product, a standard of care in the
treatment of nAMD for over a decade. We look forward to seeing the full RIVAL
dataset next year."
In data from the RIVAL study (n=278) presented today, individuals receiving the
anti-vascular endothelial cell growth factor (anti-VEGF) agent Lucentis 0.5 mg,
using a treat-and-extend treatment regimen, experienced clinically relevant
improvements in vision, measured as Best Corrected Visual Acuity (BCVA), at 12
months. The efficacy of Lucentis was demonstrated by a 7.1 letter gain, versus a
4.9 letter gain in the aflibercept 2.0 mg arm (p=0.063), with patients in both
arms receiving the same average number of injections.
Of the 30 Novartis scientific contributions at EURETINA 2017, 16 are Lucentis
oral presentations, including RIVAL and four LUMINOUS study abstracts across
five different retinal diseases.
About Lucentis (ranibizumab)
Lucentis (ranibizumab) is a humanized therapeutic antibody fragment designed to
block all biologically active forms of vascular endothelial cell growth factor-A
(VEGF-A). Increased levels of VEGF-A are seen in neovascular age-related macular
degeneration (nAMD) and other ocular diseases such as diabetic macular edema
(DME) and retinal vein occlusion (RVO). Lucentis was specifically designed for
the eye, minimizing systemic exposure.
Lucentis is indicated for the treatment of nAMD, and for the treatment of visual
impairment due to DME, branch retinal vein occlusion (BRVO), central retinal
vein occlusion (CRVO), choroidal neovascularization (CNV) secondary to
pathologic myopia (PM) and CNV associated with causes other than nAMD or
pathologic myopia (PM).
Lucentis is available in more than 110 countries and has a well-established
safety profile supported by a portfolio of 129 sponsored clinical studies in
addition to extensive real-world experience. The safety profile of Lucentis has
been well established in a clinical development program that has enrolled
approximately 120,000 patients across indications and has over 4.3 million
patient-treatment years of exposure since its launch in the United States in
2006. Lucentis was developed by Genentech and Novartis. Genentech has the
commercial rights to Lucentis in the United States. Novartis has exclusive
rights in the rest of the world.
About the RIVAL study
The RIVAL study is a 24-month, randomized, controlled, multi-center, Phase IV
study conducted in Australia. It is the first head-to-head clinical trial
designed to compare Lucentis with aflibercept in patients with neovascular age-
related macular degeneration (nAMD) using the same treat-and-extend regimen.
A total of 278 treatment-naïve patients are enrolled in the RIVAL study and
randomized to receive either Lucentis 0.5 mg or aflibercept 2.0 mg over the 24-
month study period. Patients eligible for inclusion in the study included visual
impairment of >=23 letters on a Logarithm of Minimal Angle of Resolution
(LogMAR) chart. After receiving three initial monthly injections, patients
entered the treatment and extension phase of the study, whereby the treatment
interval was extended by two weeks at a time to a maximum of 12 weeks.
The primary efficacy endpoint of the RIVAL study is defined as mean change in
the area of geographic atrophy (GA) from baseline to month 24. Results from a
pre-planned 12-month interim analysis assessed key secondary endpoints: number
of injections and change in BCVA from baseline to month 12. These findings were
presented at the EURETINA Congress in Barcelona on 9 September 2017. Full
results of the study are anticipated in 2018.
About the LUMINOUS study
The LUMINOUS study is a five-year, multi-center, global, observational study
designed to evaluate the long-term effectiveness, safety, and treatment patterns
associated with Lucentis treatment in patients with nAMD, with visual impairment
due to DME, BRVO, CRVO, and CNV in a real-world setting. It is the largest study
of its kind ever conducted.
Thirty thousand adults who have previously been treated with, who were currently
being treated with or are initiating treatment with Lucentis in the indications
nAMD or visual impairment due to DME, BRVO, CRVO, or mCNV participated in
LUMINOUS. The study was conducted in 494 sites in 43 countries.
The primary endpoints of the LUMINOUS study include mean visual acuity (VA),
mean change in VA at three, six and 12 months from baseline visit, and annually
thereafter; incidence rate, relationship and severity of treatment-emergent
ocular and non-ocular adverse events (AEs) and mean visual acuity at quarterly
intervals for the primary treated eye set.
About Novartis in Ophthalmology
Novartis is the leading ophthalmology company, with therapies that treat both
front and back of the eye disorders, including retina diseases, glaucoma, dry
eye and other external eye diseases. In 2016, 200 million patients worldwide
were treated with Novartis ophthalmic products.
Disclaimer
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About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
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E-mail: media.relations(at)novartis.com
Eric Althoff Amy Wolf
Novartis Global Media Relations Global Head Ophthalmology Communications
+41 61 324 7999 (direct) +41 61 696 5894 (direct)
+41 79 593 4202 (mobile) +41 79 576 07 23 (mobile)
eric.althoff(at)novartis.com amy.wolf(at)novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
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Central North America
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 09.09.2017 - 11:00 Uhr
Sprache: Deutsch
News-ID 559330
Anzahl Zeichen: 13032
contact information:
Town:
Basel
Kategorie:
Business News
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