13.10.2005 21:38:00
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Safety of Alcon's RETAANE(R) Suspension Confirmed at 24 Months; Data Supports Clinical Equivalence to VISUDYNE
The primary purpose of the 24 month analysis was to confirm thelong term safety of RETAANE(R) suspension. Safety information fromthis study showed that no clinically relevant safety issues wereobserved due to the drug or the posterior juxtascleral depot procedureduring entire course of the study. Ocular and non-ocular adverseevents were reported at similar rates in both arms of the study.
In addition to the safety data, the company said two year datacontinued to show RETAANE(R) suspension is clinically equivalent toPDT with VISUDYNE(a). Furthermore, the mean visual acuity for bothtreatment groups was clinically stable from month 12 to month 24.
"We believe this data indicates that RETAANE(R) suspension has thepotential to play a unique role in the chronic treatment of wet AMD,"said Stella Robertson, PhD and vice president, ophthalmic development."We continue to have discussions with the FDA and other regulatoryagencies around the world to gain approval of this drug."
About RETAANE(R) suspension
RETAANE(R) suspension is an investigational treatment formaintaining vision in patients with wet AMD. The drug is anangiostatic cortisene that inhibits the abnormal growth of bloodvessels, a process scientifically known as angiogenesis. Angiostaticcortisenes are derived from the steroid class and engineered to removechemical groups responsible for side effects, such as the developmentof cataracts and elevated intraocular pressure leading to glaucoma,while preserving potency against angiogenesis.
RETAANE(R) suspension is administered with a blunt-tipped, curvedcannula to deliver the drug behind the eye without puncturing theeyeball. This method of delivery avoids the risk of intraocularinfection and retinal detachment, the most common side effectsassociated with injecting therapeutic agents directly into the eye. Inaddition, RETAANE(R) suspension requires less frequent dosing (onceevery six months) compared to some other investigational drugs, whichare injected into the eye as often as 9 to 12 times a year.
Alcon has received an approvable letter from the U.S. Food andDrug Administration for its New Drug Application (NDA) for RETAANE(R)suspension. The company also is actively pursuing approval ofRETAANE(R) suspension in the European Union, Canada, Switzerland andAustralia.
About Alcon
Alcon, Inc. is the world's leading eye care company. Alcon, whichhas been dedicated to the ophthalmic industry for over 50 years,develops, manufactures and markets pharmaceuticals, surgical equipmentand devices, contact lens solutions and other vision care productsthat treat diseases, disorders and other conditions of the eye. Alconhas been conducting retinal research for more than 15 years and is theworld's leading provider of surgical equipment used by vitreoretinalspecialists who treat patients with AMD and other retinal diseases.Alcon has multiple programs to investigate, discover and develop novelcompounds to treat AMD and other retinal diseases.
(a) VISUDYNE is a registered trademark of QLT Therapeutics, Ltd.
Caution Concerning Forward-Looking Statements. This press releasecontains forward-looking statements within the meaning of the PrivateSecurities Litigation Reform Act of 1995, relating principally to ourability to gain approval of RETAANE(R) suspension of our NDA from theFDA and the expected benefits of RETAANE(R) suspension in treatingAMD. These statements involve known and unknown risks, uncertaintiesand other factors which may cause our actual results, performance orachievements to be materially different from any future results,performances or achievements expressed or implied by ourforward-looking statements. These statements reflect the views of ourmanagement as of the date of this press release with respect to futureevents and are based on assumptions and subject to risks anduncertainties. Given these uncertainties, you should not place unduereliance on these forward-looking statements. Factors that mightcause future results to differ include, but are not limited to, thefollowing: we may never gain approval of our NDA for RETAANE(R)suspension to the FDA, or approval of the NDA may take longer than weexpect; treatments developed by other companies may reach the marketsooner or prove to be more effective than RETAANE(R) suspension;challenges inherent in new product marketing; and governmentregulation and legislation. You should read this press release withthe understanding that our actual future results may be materiallydifferent from what we expect. Except to the extent required under thefederal securities laws and the rules and regulations promulgated bythe Securities and Exchange Commission, we undertake no obligation topublicly update or revise any of these forward-looking statements,whether to reflect new information or future events or circumstancesor otherwise.
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