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NDA 2 l-368 Page2 We remind you of the postmarketingstudy commitment you Mayan a letter dated November 19, 2003. The commitments listed below: 1. To conduct randomized, placebo-controlledstudy investigating

It is your responsibility to notify Pfizer of these obligations and your intention to complete the Protocols. 2. To obtain a grant of investigationalapplications for the Phase I investigation, the Protocols and the complete study protocol will be required by February 1, 2004, or such other date the KEPI Committee sets forth in the notice of approval as is acceptable to Pfizer. This timeline will be used to define the maximum allowable duration of the Phase I trial, and the maximum duration of the study and will have to be respected until completion of the study. 3. As a final step to completing the Protocols, Pfizer may require, from June 1 to August 31 1, 2004, completion of the Protocols by the End clinical trial staff (including submission of final draft Protocol, completed study protocol as well as supporting data). 4. At Pfizer's discretion, Pfizer may require, from September 1 to December 31 1, 2004, complete protocol and final report within 30 days of the letter of approval. If a final report is not received before February 1, 2004, we will be required to close the investigation and Pfizer will notify the end staff and other participants in accordance with the Protocol provisions and the final report requirements in the above list. If a final report is received and approved by Pfizer before February 1, 2004, Pfizer will issue a new protocol after receiving the final report. If a final report is not received and approved by Pfizer, Pfizer will issue a new protocol after receiving the final report. We suggest that you contact an ophthalmologist for clarification on the date on which final reports should be received. 5. To assure that the end staff is provided with adequate resources, we respectfully request that you provide these guidelines to the end staff to support their performance of the Phase I investigations. 6. These guidelines will be used, to the maximum extent possible, to minimize Phase I study resources in order to prevent the need to close the investigation, including the potential requirement for an extension of the Phase I investigation at the time a new study, a Phase II trial, or a Phase III trial begin in order to minimize these resources. 7. The information in this document is current as of November 2003. Pfizer is working in collaboration with Ophthalmology Associates of the UK to facilitate communication by providing the above document. Further information regarding the use of this document in this study is contained in Section 7.1.

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