Short-Term Pipeline
Alcon is developing new products to treat diseases and conditions in all key eye care categories: surgical, pharmaceutical and consumer vision care products. We also have targeted development activities in the otic and nasal areas.
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, 2008 (1) |
|---|---|---|---|
| Pharmaceutical | |||
| DuoTrav™ | Glaucoma | Jpn Filed | Filed |
| Aganocide | Anti-infective | U.S. 2011 or later | Phase I/II |
| EU 2011 or later | |||
| Jpn 2011 or later | |||
| Vigamox® | Anti-infective | EU Filed | Filed |
| Moxifloxacin, new formulation | Anti-infective | U.S. Filed (2) | Filed |
| NEVANAC® | Anti-inflammatory | Jpn Filed | Filed |
| AL-43,546 | Dry eye | U.S. 2011 or later | Phase I/II |
| EU 2011 or later | |||
| Jpn 2011 or later | |||
| Hyaluronic acid (3) | Dry eye | U.S. 2009 | Pre-submission |
| Triesence® injectable suspension | Retinal surgery | EU 2009 | Pre-submission |
| Jpn 2009 | Pre-submission | ||
| Otic/Nasal | |||
| Moxifloxacin/ dexamethasone |
Anti-infective & anti-inflammatory | U.S. 2011 or later (2) | Phase III |
| Patanase® pediatric | Allergy | U.S. 2009 | Phase III |
| Surgical | |||
| AcrySof ® Toric diopter range expansion | Cataract | U.S. 2011 or later | Advanced development |
| EU 2009 | Advanced development | ||
| AcrySof ® ReSTOR® diopter range expansion | Cataract | U.S 2009 | Advanced development |
| EU 2009 | Advanced development | ||
| AcrySof ® ReSTOR® Aspheric, +3.0 add lens | Cataract | Jpn 2009 | Advanced development |
| AcrySof ® ReSTOR® Toric lens | Cataract | U.S. 2011 or later | Advanced development |
| EU 2011 or later | |||
| Jpn 2011 or later | |||
| AcrySof ® angle-supported phakic lens | Refractive | U.S. 2009 | Advanced development |
| Jpn 2011 or later | |||
| DisCoVisc® viscoelastic | Cataract | Jpn Filed | Filed |
| Consumer Vision Care | |||
| Systane® Ultra unit dose | Dry eye | U.S. 2009 | Advanced development |
| Systane® ORB | Dry eye | U.S. 2009 | Advanced development |
| OPTI-FREE® multi-purpose solution | Lens solution | Jpn Filed | Filed |
| OPTI-FREE® silicone hydrogel | Lens solution | U.S. 2010 | Early development |
| EU 2010 | Early development | ||
| ICAPS® next generation | Ocular vitamin | U.S. 2009 | Advanced development |
| EU 2009 | Advanced development | ||
| ICAPS® AREDS2 | Ocular vitamin | U.S. 2011 or later | Early development |
| EU 2011 or later | Early development | ||
(1) For a description of the FDA approval process, see "Government Regulation" in our 20F filed with the SEC.
(2) 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. As a result, additional Phase III clinical studies may be required for approval.
(3) This project is being managed and conducted by River Plate Biotechnology, Inc., which filed its NDA in
January 2009.
