company memo MEMO TO: Analysts/Investors
FROM: Therese Crozier, Senior Director Investor Relations, QLT
Inc.
DATE: September 26, 2002
SUBJECT: Retina 2002 Congress
_________________________________________________________________________________________________________________
This weekend up to 2000 retinal specialists will congregate in San
Francisco for the Annual Joint Meeting of the Retina and Vitreous
Societies. Visudyne® will be very well represented during the course of
the meeting particularly on Sunday's Photodynamic Therapy (PDT) day with
approximately 14 papers presented and another dozen posters scheduled.
As a reminder Visudyne has no near-term competition and even according to
competitor companies' guidance the potential for competition is not
expected until late 04/05. However, we do expect some visibility at the
conference on the competitive landscape including a number of
presentations of adjunctive therapies (in combination with Visudyne).
Alcon is scheduled to present their one-year results from the Anecortave
Phase II trial in classic AMD and Genentech is scheduled to present
clinical results for their Phase I/II study of its anti-angiogenic
rhuFabV2. We look forward to the presentation of their data and remind
investors of the parameters that need to be considered when reviewing or
comparing data sets.
Comparisons between Phase II and Phase III trials are not always reliable
particularly in highly variable diseases such as AMD. The FDA has
historically required two well controlled Phase III studies involving
hundreds of patients for approvals in AMD. While a number of endpoints
may be of clinical interest, the endpoint that the FDA used to review
Visudyne was the difference in the three-line vision loss. Furthermore
for FDA approval a benefit needs to be achieved in the overall patient
population, not just in a subgroup.
Visudyne has a significant lead time over potential competitors and with
this first mover advantage as well as the long-term safety and efficacy
data now available we believe that clearly superior results to those
found with Visudyne would be necessary to significantly displace
Visudyne.