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
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.
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.
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.
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.
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.
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*Pataday® (olopatadine hydrochloride ophthalmic solution) 0.2%, a prescription product marketed by Alcon, is used to treat ocular itching associated with eye allergies.
 American College of Allergy, Asthma & Immunology, Allergy Facts. http://acaai.org/news/facts-statistics/allergies [Accessed December 10, 2014]
 WebMD, Allergies Health Center. http://www.webmd.com/allergies/guide/eye-allergies-1 [Accessed December 10, 2014]
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