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 timelime.
To see complete details about Alcon activity, see our latest SEC filing, 20-F.
| Category & Name | Condition | Expected U.S. Submission Date* | Status at December 31, 2007 (1) |
|---|---|---|---|
| Pharmaceutical | |||
| Anecortave acetate | Glaucoma | 2010 or later | Phase II/III |
| AL-37807 | Glaucoma | 2010 or later | Phase II |
| RETAANE® anecortave acetate suspension | AMD risk reduction | 2010 or later | Phase III |
| Moxifloxacin, new formulation | Anti-infective | 2008 (2) | Phase III |
| TobraDex® ST | Anti-infective/ anti-inflammatory |
Filed | Filed |
| Moxifloxacin/ dexamethasone |
Anti-infective/ anti-inflammatory |
2010 or later (2) | Phase III |
| Nasal | |||
| Patanase® nasal spray | Allergy | Filed | Filed |
| Otic | |||
| Moxifloxacin/ dexamethasone |
Otic | 2010 or later (2) | Phase III |
| Surgical | |||
| AcrySof® ReSTOR® IOL +3.0 Add | Cataract | 2008 | Advanced development |
| AcrySof® Low Power ReSTOR® lens | Cataract | 2009 | Advanced development |
| AcrySof® ReSTOR® Toric lens | Cataract | 2010 or later | Advanced development |
| New CONSTELLATION® vitreoretinal system | Vitreoretinal | 2008 | Advanced development |
| New irrigating solution | Cataract/ vitreoretinal |
Filed | Filed |
| AcrySof® angle-supported phakic lens | Refractive | 2010 or later | Advanced Development |
| Consumer Vision Care | |||
| Enhanced OTC tear substitute | Dry eye | 2008 | Advanced development |
| ICAPS® enhancement | Ocular vitamin | 2008 | Advanced development |
(1) Please refer to "Risk Factors – Risks Related to Our Business and Industry – We are subject to extensive government regulation that increases our costs and could prevent us from selling ourproducts" in our 20F filed with the SEC on March 18, 2008.
(2) The FDA issued a notice in the fall of 2007 advising companies to meet with them regarding development of antiinfectiveproducts. In brief, the FDA advised that they were increasing the requirements for anti-infective clinicalstudies 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.
*The expected submission dates in the table above reflect those for the United States. We also expect to file for approval ofthese products in most of the countries where we currently market our products. For pharmaceutical and consumer eye careproducts, these approvals generally are received after U.S. approvals. For surgical products, these approvals are oftenobtained before U.S. approvals. We maintain a significant regulatory presence in major countries to support the filing processoutside the United States.
