Alcon receives FDA approval of Pazeo(TM) Solution for ocular allergy itch relief
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Alcon receives FDA approval of Pazeo(TM) Solution for ocular allergy itch relief
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* US Food and Drug Administration grants approval of Pazeo(TM) (olopatadine
hydrochloride ophthalmic solution) 0.7% for sale in the United States
* Developed with efficacy data at 24 hours, post dose, to provide one-drop
daily ocular itch relief associated with allergic conjunctivitis (eye
allergies)
* Up to 30% of the U.S. population is affected by seasonal allergy symptoms,
with as many as 70 to 80% of these demonstrating ocular symptoms such as
itching[1]
Basel, February 2, 2015 - Alcon, the global leader in eye care and a division of
Novartis, has received approval from the US Food and Drug Administration (FDA)
of Pazeo(TM) (olopatadine hydrochloride ophthalmic solution) 0.7%, for the
treatment of ocular itching associated with allergic conjunctivitis. Pazeo
solution is dosed one drop daily, and was approved with efficacy data at 24
hours, post dose.
"Pazeo solution represents an important addition to our ocular allergy portfolio
in the United States," said Sabri Markabi, Senior Vice President, Research &
Development for Alcon. "Patients who experience itching due to allergic
conjunctivitis (eye allergies), will now be able to turn to a one-drop daily
product with efficacy data 24 hours after dosing."
As much as 30% of the U.S. population is affected by seasonal allergy symptoms,
and up to 70 to 80% of these demonstrate ocular symptoms such as itchy eyes.[1]
Results from two Conjunctival Allergen Challenge clinical studies showed that
Pazeo (olopatadine hydrochloride ophthalmic solution) 0.7%, demonstrated
statistically significantly improved relief of ocular itching associated with
allergic conjunctivitis at 24 hours post-treatment compared to olopatadine 0.2%
(known as Pataday(®) solution).* The safety profile of Pazeo solution is
comparable to that of olopatadine 0.2%. In the two clinical studies, the most
common adverse reactions occurred in 2 to 5% of patients treated with either
Pazeo solution or a vehicle. These events were blurred vision, dry eye,
superficial punctate keratitis, dysgeusia and abnormal sensation in the eye.
"Allergic conjunctivitis (eye allergies) can be a 24-hour-a-day burden for
patients suffering from those symptoms," said Eric Donnenfeld, MD, founding
partner of Ophthalmic Consultants of Long Island and clinical professor of
ophthalmology at New York University. "Patients now have an available option
that can provide ocular itch relief with efficacy demonstrated at 24 hours. This
approval represents an exciting new option in ocular allergy itch relief
therapy."
Pazeo solution is anticipated to be available by prescription in the United
States in March 2015, followed by Latin American and Asian markets through 2017.
About Allergic Conjunctivitis
Allergic conjunctivitis is more commonly referred to as eye allergies and
affects the conjunctiva, which is the clear layer of skin overlying the eyes.
Eye allergies are not typically harmful to a person's eyes or vision; however,
they can cause discomfort. The most common subtypes of allergic conjunctivitis
are seasonal allergic conjunctivitis, which lasts for a short period of time,
and perennial allergic conjunctivitis, a chronic, year-round condition.[2]
Important Safety Information About Pazeo (olopatadine hydrochloride ophthalmic
solution) 0.7%
As with any eye drop, care should be taken not to touch the eyelids or
surrounding areas with the dropper tip of the bottle to prevent contaminating
the tip and solution. Keep bottle tightly closed when not in use.
Patients should not wear a contact lens if their eye is red. The preservative in
Pazeo solution, benzalkonium chloride, may be absorbed by soft contact lenses.
Patients should be instructed to wait at least five minutes after instilling
Pazeo solution before they insert their contact lenses. For additional
information about Pazeo solution, please refer to the full prescribing
information.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "will," "can," "anticipated," or similar terms, or by express
or implied discussions regarding potential future marketing approvals for Pazeo,
or regarding potential future revenues from Pazeo. 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 Pazeo
will be submitted or approved for sale in any additional markets, or at any
particular time. Nor can there be any guarantee that Pazeo will be commercially
successful in the future. In particular, management's expectations regarding
Pazeo 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 and sell products in more
than 180 countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
*Pataday(®) (olopatadine hydrochloride ophthalmic solution) 0.2%, a prescription
product marketed by Alcon, is used to treat ocular itching associated with eye
allergies.
References:
[1] American College of Allergy, Asthma & Immunology, Allergy Facts.
http://acaai.org/news/facts-statistics/allergies [Accessed December 10, 2014]
[2] WebMD, Allergies Health Center. http://www.webmd.com/allergies/guide/eye-
allergies-1 [Accessed December 10, 2014]
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Datum: 02.02.2015 - 07:15 Uhr
Sprache: Deutsch
News-ID 368314
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