Alcon

To balance resource use with the strongest likelihood of success, Alcon continuously evaluates its pipeline products to determine the most promising projects to advance through the many phases of clinical testing. The following table includes additional detail about each of these products in development, including the expected regulatory submission date in the U.S. Submissions to regulatory bodies outside of the U.S. may have a different timeline.

To see complete details about Alcon activity, see our latest SEC filing, 20-F.

Category & Name	Condition	Expected Submission Date	Status at December 31, 2010 (1)
Pharmaceutical
Ophthalmology
DuoTrav® APS	Glaucoma	EU Filed	Filed
AZARGA®	Glaucoma	Jpn 2012	Phase III
New combination	Glaucoma	U.S. 2012 EU 2013 or later	Phase III
NEVANAC®, new indication	Anti-inflammatory	EU Filed	Filed
Nepafenac, new fomulation	Anti-inflammatory	U.S. 2012 EU 2012	Phase III
DUREZOL®, new indication	Anti-inflammatory	U.S. 2011	Phase III
Pataday™	Ocular allergy	Jpn Filed	Filed
AL-43,546	Dry Eye	Jpn 2013 or later	Phase II
TRIESENCE® injectable suspension	Retinal Surgery	EU Filed	Filed
Otic/Nasal
CiloDex® otic solution	Otic infections	EU Filed (2)	Withdrawn (3)
Moxifloxacin / dexamethasone	Otic infections	U.S. 2012 (4) EU 2012 or later	Phase III
Surgical
AcrySof® IQ Toric diopter range expansion	Cataract	U.S. Filed Jpn Filed	Filed
AcrySof ® IQ Toric low diopter range expansion	Cataract	U.S. 2012	Advanced development
AcrySof ® IQ ReSTOR® Multifocal Toric lens	Cataract	U.S. 2012 Jpn 2011	Advanced development
AcrySof ® IQ ReSTOR® Toric diopter range expansion	Cataract	U.S. 2012 or later	Advanced development
AcrySof ® IQ ReSTOR® distant dominant	Cataract	U.S./EU 2012 or later	Advanced development
Infiniti® upgrade	Cataract	U.S./EU 2011 Jpn 2012	Advanced development
LenSx laser	Cataract	EU/Jpn 2011	Advanced development
AcrySof ®  CACHET™ angle-supported phakic lens	Refractive	U.S. Filed Jpn 2012	Filed Advanced development
ALLEGRETTO™ EX-500 laser ALLEGRETTO™ EX-400 laser	Refractive Refractive	U.S. Filed Jpn Filed	Filed Filed
Consumer Eye Care
New formulation	Dry Eye	U.S./EU 2011	Advanced development
Lens comfort drop	Lens solution	U.S./EU 2012	Early development
OPTI-FREE® silicone hydrogel	Lens solution	U.S. Filed	Filed
New lens solution	Lens solution	U.S./EU 2011	Advanced development
ICAPS® R2	Ocular vitamin	EU 2011	Advanced development
ICAPS® AREDS2	Ocular vitamin	U.S./EU 2012 or later	Early development

 

(1) For a description of the FDA approval process, see "Government Regulation" in our 20F filed with the SEC. 

(2) This application was filed in Denmark, France, Germany, Italy, Spain and the United Kingdom. 

(3) This application was withdrawn in November 2010 for administrative reasons and will be refiled early in 2011. 

(4) The FDA issued a notice in the fall of 2007 advising companies that they were increasing the requirements for anti-infective clinical studies and that clinical programs previously agreed upon may not be sufficient to support approval.  Review of our NDA confirmed the need for an additional clinical study which was initiated in a timely manner. 

 

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