Full Press Release Details
Alcon Releases Clinical Results on New Nasal Allergy Spray
Fort Worth, TX, March 21, 2004 Alcon announced
today results from a Phase III clinical trial demonstrating that olopatadine nasal spray, a nasal formulation
of its market leading ophthalmic anti-allergy product, Patanol ophthalmic
solution, reduced seasonal allergic rhinitis symptoms compared to placebo. The results of this multi-center,
randomized, double-blind, placebo-controlled study of 677 patients were presented at the annual meeting
of the American Academy of Allergy Asthma and Immunology (AAAAI) in San Francisco.
ranging in age from 12 to 81 were dosed with either olopatadine nasal spray (0.6% or 0.4%) or a placebo
spray twice a day for two weeks. Every day during the study, patients recorded a morning and evening
assessment of the severity of nasal allergy symptoms on a scale of zero to three, including both a reflective
and instantaneous rating. The reflective rating assessed how the patient felt over the course of the
day, while the instantaneous rating assessed how the patient felt immediately after using the spray.
The primary objective of the study was to determine the change from baseline in the total nasal symptom
score, defined as the average of the morning and evening reflective severity scores for all patients
across all days. The nasal composite score measured a combination of sneezing and stuffy, runny and
itchy nose symptoms. The study also measured each individual symptom s reflective score. These results
confirmed a similar Phase III clinical trial conducted late last year and are summarized in the table
| Percentage Change from Baseline Score | |||||||
| Measure | Olopatadine 0.6% | Olopatadine 0.4% | Placebo | ||||
| Total nasal symptoms - reflective | *30.1% | *27.6% | 18.7 | % | |||
| Total nasal symptoms - instantaneous | *26.2% | *24.3% | 15.8 | % | |||
| Stuffy nose | *21.7% | *21.3% | 13.2 | % | |||
| Runny nose | *30.0% | 22.3% | 18.4 | % | |||
| Itchy nose | *32.4% | *30.8% | 19.4 | % | |||
| Sneezing | *35.7% | *33.4% | 18.8 | % |
*Percent change from baseline statistically significant
addition to reporting the severity of nasal allergy symptoms, patients also completed a Rhinoconjunctivitis
Quality of Life (RQLQ) questionnaire. Well-recognized in the allergy community, this questionnaire measures
the overall physical and emotional well-being of patients suffering from rhinoconjunctivitis on a scale
of zero to six with lower scores representing improvement. Both olopatadine 0.6% and olopatadine 0.4%
demonstrated a statistically significant 1.1 unit improvement from baseline in the average overall RQLQ
score versus an improvement of only 0.8 unit for placebo. The study concluded that the improvement in
olopatadine spray s overall RQLQ scores were clinically significant.
Wall, Ph.D., Alcon s senior director of otic and nasal product development, said, We believe these
clinical results demonstrate that olopatadine nasal spray is effective in reducing the symptoms associated
with SAR, as well as providing improved quality of life for allergy sufferers. In addition, the clinical
results demonstrated that olopatadine spray is safe and well-tolerated.
About Nasal Allergies*
rhinitis, the medical term for nasal allergies, refers to an allergic complex of symptoms caused by
sensitivity to pollens, mold, dust or animal dander. Symptoms may include sneezing, congestion, itchy
nose, excess mucus, watery eyes, itchy eyes, sinus headaches and a scratchy palate and throat. Allergies
can be seasonal, caused by pollen from trees, grasses and weeds, or they can be year round, most often
caused by an allergy to dust mites, mold or animal dander.
to the AAAAI, approximately 36 million Americans suffer from allergic rhinitis. Current methods of treatment
include prescription and over-the-counter antihistamines and decongestants, as well as nasal sprays,
most of which are topical corticosteroids. Many of the medicines available without a prescription can
cause side effects, such as sleepiness, irritability, anxiety or difficulty falling asleep.
corticosteroid sprays are used daily as preventive medications; however, they often do not offer immediate
relief. Full effectiveness may require anywhere from a few days to three weeks of daily application.
About Olopatadine Nasal Spray
olopatadine used in this spray is the same active ingredient in Alcon s market-leading Patanol
ophthalmic solution, which is indicated for the treatment of the signs and symptoms
associated with allergic conjunctivitis. Dr. Lanny Rosenwasser, president of the AAAAI, said, I m excited
about the potential of offering my patients a nasal spray with good safety and efficacy that is not
a steroid. Allergy sufferers need a drug that will work quickly to alleviate nasal allergy symptoms
with minimal side effects.
the leader in ocular allergy treatments, has developed this drug because many of the triggers that cause
eye allergies also cause nasal allergies. Last year, doctors wrote more than 33 million prescriptions
for nasal allergies, as compared to five million for ocular allergies. Mike Hemric, Alcon s vice president
and general manager of Pharmaceuticals, noted, Olopatadine nasal spray represents an opportunity to
extend our successful Patanol franchise into a new area that accounts
for a much larger number of total topical allergy prescriptions.
Inc. (NYSE:ACL) is the world s leading eye care company. Alcon, which has been dedicated to the ophthalmic
industry for over 50 years, develops, manufactures and markets pharmaceuticals, surgical equipment and
devices, contact lens solutions and other vision care products that treat diseases, disorders and other
conditions of the eye.
*Source: Selected data from www.aaaai.org.
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995, relating principally to
the potential for olopatadine nasal spray to play a role in the treatment of seasonal allergic rhinitis.
These statements involve known and unknown risks, uncertainties and other factors that may cause our
actual results, performance or achievements to be materially different from any future results, performances
or achievements expressed or implied by our forward-looking statements. These statements reflect the
views of our management as of the date of this press release with respect to future events and are based
on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place
undue reliance on these forward-looking statements. Factors that might cause future results to differ
include, but are not limited to, the following: the U.S. Food and Drug Administration may not approve
our new drug application or it may take longer than expected to receive approval; treatments developed
by other companies may reach the market sooner or prove to be more effective than olopatadine nasal
spray; we may have to conduct additional studies to gain approval; the market acceptance of olopatadine
nasal spray may not be as great as expected; we may face challenges and incur costs inherent in new
product marketing; and government regulation and legislation that may affect the demand for and revenues
of olopatadine nasal spray, if any. You should read this press release with the understanding that our
actual future results may be materially different from what we expect. Except to the extent required
under the federal securities laws and the rules and regulations promulgated by the Securities and Exchange
Commission, we undertake no obligation to publicly update or revise any of these forward-looking statements,
whether to reflect new information or future events or circumstances or otherwise.
about Alcon, contact:
Doug MacHatton (Investor Relations)
other inquiries: Mary Dulle (Public Relations)
817-551-8058 or pager 817-418-8990