Positive phase II data highlights benefits of Alcon's RTH258 for patients with neovascular (wet) age-related macular degeneration
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Novartis International AG /
Positive phase II data highlights benefits of Alcon's RTH258 for patients with
neovascular (wet) age-related macular degeneration
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* Phase II study met primary endpoint, demonstrating promising visual acuity
gains in patients with neovascular (wet) age-related macular degeneration
* Data shows the potential for less frequent dosing and reduced treatment
burden with RTH258 compared to aflibercept
* Phase III clinical trial program initiated in December 2014, with 1700
patients expected to be enrolled in more than 50 countries
Basel, February 27, 2015 - Alcon, the global leader in eye care, presented
positive results from its second Phase II clinical study of RTH258 during the
38(th) Annual Macula Society Meeting in Scottsdale, Arizona. This study
evaluated the efficacy and safety of the compound versus aflibercept in patients
with neovascular (wet) age-related macular degeneration (AMD). RTH258 (formerly
known as ESBA1008) is a novel, single-chain antibody fragment developed to treat
wet AMD.
The Phase II study met its primary endpoint, demonstrating promising visual
acuity gains that were non-inferior to aflibercept, with numerically greater
reduction and rapid improvement in abnormal retinal fluid observed in RTH258-
treated patients. Patients treated every three months with RTH258 also
experienced a prolonged duration-of-action, potentially leading to a reduced
treatment burden. A total of 90 patients diagnosed with wet AMD participated in
the prospective, randomized, double-masked multicenter, two-arm study. The
primary objective was to compare the efficacy of RTH258 6mg versus aflibercept
2mg with the primary endpoint being the mean change in best corrected visual
acuity (BCVA), from Baseline to Week 12. Secondary endpoints included the change
assessment in BCVA and central subfield foveal thickness (CSFT) as measured by
spectral domain optical coherence tomography (SD-OCT). Both RTH258 and
aflibercept were well tolerated and no new safety signal was reported during the
study.
"Alcon is deeply committed to addressing unmet patient needs in retina, and
RTH258 demonstrates the potential to improve visual outcomes and reduce the
treatment burden for patients with wet AMD," said Sabri Markabi, Senior Vice
President, Research & Development for Alcon. "We have initiated our Phase III
study program based on the encouraging results we received from the Phase II
studies with RTH258."
RTH258 Phase III Study Program Initiated
With these positive Phase II results, Alcon has initiated its Phase III clinical
study program to evaluate the efficacy and safety of RTH258 versus aflibercept
in patients with wet AMD. As part this innovative study program, Alcon expects
to enroll approximately 1,700 patients in more than 50 countries worldwide. The
primary objective of the first Phase III study is to compare the efficacy of
RTH258 3mg and 6mg versus aflibercept 2mg, with the mean change in BCVA, from
Baseline to Week 48 as the primary endpoint. The second study within the Phase
III trial program will also compare the efficacy of RTH258 versus aflibercept,
and is expected to commence in 2015. Patients participating in the Phase III
studies will be dosed every three months with RTH258, while a bi-monthly-dosing
regimen will be followed for those patients considered unsuitable for a
quarterly dosing schedule due to disease activity. Aflibercept will be dosed
according to its approved label. Please visit www.clinicaltrials.gov for further
details about the RTH258 Phase III clinical trial program.
AMD is a leading cause of severe vision loss in people over age 50,[1],[2] and
the United Nations estimates that it impacts 25 to 30 million people
worldwide.[3] AMD occurs when the center of the retina, known as the macula,
deteriorates leading to gradual loss in central vision.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "potential," "expected," "promising," "potentially,"
"committed," "encouraging," "to evaluate," "expects," "will," or similar terms,
or by express or implied discussions regarding potential marketing approvals for
RTH258, or regarding potential future revenues from RTH258. You should not place
undue reliance on these statements. Such forward-looking statements are based on
the current beliefs and expectations of management 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 RTH258
will be submitted or approved for sale in any market, or at any particular time.
Nor can there be any guarantee that RTH258 will be commercially successful in
the future. In particular, management's expectations regarding RTH258 could be
affected by, among other things, the uncertainties inherent in research and
development, including unexpected clinical trial results and additional analysis
of existing clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry conditions;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected manufacturing issues, 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 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 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,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and over-the-
counter products. Novartis is the only global company with leading positions in
these areas. In 2014, the Group achieved net sales of USD 58 billion, while R&D
throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion
excluding impairment and amortization charges). Novartis Group companies employ
approximately 130,000 full-time-equivalent associates. Novartis products are
available in more than 180 countries around the world. For more information,
please visit http://www.novartis.com.
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http://twitter.com/novartis.
*Aflibercept is marketed under the brand name of Eylea(®) in the United States
by Regeneron and outside the United States by Bayer, and is a prescription
medicine for the treatment of patients with wet AMD, macular edema following
retinal vein occlusion (RVO), and diabetic macular edema (DME).
References
[1] National Eye Institute. Facts About Age-Related Macular Degeneration.
http://www.nei.nih.gov/health/maculardegen/armd_facts.asp.
[2] Klein R, et al "Incidence of visual impairment over a 20-year period"
Ophthalmology 2013; DOI: 10.1016/j.ophtha.2013.11.041.
http://bmctoday.net/practicaldermatology/dermwire/view.asp?20130405-
amd_remains_leading_cause_of_vision_loss.
[3] BMJ, 2003 March 1; 326(7387): 485-488.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1125371/
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Datum: 27.02.2015 - 17:30 Uhr
Sprache: Deutsch
News-ID 374943
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