Favorable Visudyne clinical results announced for occult AMD and pathologic myopia patients

13-Feb-2001

Novartis Ophthalmics, the eye health unit of Novartis Pharma AG, and QLT Inc. today announced top-line results that showed Visudyne therapy reduces the risk of vision loss in a new population of patients with wet age-related macular degeneration (AMD).

The results were from a multi-center phase IIIb randomized placebo-controlled study, called the VIP (Verteporfin In Photodynamic therapy) trial in which most patients had lesions composed of occult subfoveal choroidal neovascularization (CNV) without classic components. "Occult" and "classic" are terms used to describe different patterns of CNV leakage as seen on fluorescein angiography. Visudyne is currently approved for the treatment of patients with predominantly classic subfoveal CNV caused by AMD, the leading cause of severe vision loss in people over the age of 50. In addition, the results also confirmed the benefits of Visudyne therapy at 24 months in the treatment of CNV due to pathologic myopia, for which regulatory approval is pending in North America and Europe.

"Results from this new study are extremely important because they demonstrate that Visudyne therapy can reduce the risk of moderate to severe vision loss in a large number of patients each year for whom, previously, there was no proven treatment," said Dr. Neil Bressler, retinal specialist and Chair of the Visudyne Study Advisory Group. Dr. Bressler is also the James P. Gills Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine in Baltimore, Maryland.

"These results represent a significant milestone in our efforts to expand the use of Visudyne so that most patients with wet AMD can one day benefit from Visudyne therapy," said Dr. Julia Levy, President and Chief Executive Officer of QLT. "We plan to consult with regulatory authorities to determine how best to proceed from a regulatory and clinical standpoint."

"Visudyne has already gained a wide acceptance around the world having received regulatory approval in 31 countries," said Luzi von Bidder, Head of Novartis Ophthalmics. "With respect to this new information, we will work aggressively, to make this therapeutic advance available to this new patient population as quickly as possible."

A complete analysis of the results is currently underway. Further details will be submitted for publication in a peer-reviewed medical journal and presented at the Association for Research in Vision and Ophthalmology (ARVO), to be held April 29 to May 4, 2001 in Fort Lauderdale, Florida.

https://www.chemeurope.com/en/news/1273/favorable-visudyne-clinical-results-announced-for-occult-amd-and-pathologic-myopia-patients.html