New Data From Visudyne(R) In Minimally Classic(VIM) Trial Confirm Importance Of Lesion Size In The Treatment Of "Wet" AMD

MADRID (ots/PROTEXT) - New data from the VIM study presentedtoday at the annual Congress of the European Society ofOphthalmology (SOE) demonstrate that Visudyne(R) therapybenefited patients with smaller base line lesions* in minimallyclassic "wet" AMD, a form of AMD previously considereduntreatable.1 Visudyne is the only drug approved for other formsof wet AMD, the leading cause of blindness in people over theage of 50.

Furthermore, these twelve-month data showed that patientstreated with Visudyne had an increased chance of their visionstabilising or improving compared with placebo. Visudyne treatedpatients also had a reduced risk of developing predominantlyclassic CNV, considered a more aggressive form of the disease.

"The results of the VIM trial are promising." said JordiMones, Professor of Ophthalmology, Barcelona Institute of OcularMicrosurgery, Spain. "This study, designed to investigate thevision outcomes in minimally classic lesions with smaller lesionsize, reinforces the ophthalmic community's widely held beliefthat lesion size is equally as important as lesion composition ininfluencing treatment outcomes in patients with minimallyclassic or occult AMD. These observations will simplify currentmanagement of AMD and we expect further demonstration in ongoingprospective studies."

Retrospective analyses of the data from patients with occultAMD in the Verteporfin in Photodynamic Therapy trial (VIP)further emphasise the importance of lesion size. The resultsshowed a correlation between lesion size, baseline visual acuityand vision outcomes. Patients with smaller lesions benefited themost from Visudyne therapy compared with the group whose lesionswere larger. Compared to patients with larger lesion, thesepatients demonstrated a statistically significant improvementin, and stabilisation of vision and showed similar treatmentoutcomes as for predominantly classic lesions.

* Lesion size of less than 6 Disc Areas

Gisele Soubrane, Professor and chair in Ophthalmology, EyeUniversity Clinic of Creteil, France said: "Retrospectiveanalysis of the VIP data showed that Visudyne is even moreeffective in patients with smaller occult AMD lesions. Prompttreatment with Visudyne, now widely accepted to be the standardof care in wet AMD, is an important factor in stabilising andmaintaining vision in the long term, thereby preserving patientquality of life."

Novartis Ophthalmics and QLT, Inc., partners in developingVisudyne, are working to enhance the benefits offered topatients by this therapy through a comprehensive, on-goingclinical trial program involving more than 1,000 patients. TheHelen Keller Foundation for Research and Education has awardedboth companies with the prestigious Helen Keller Prize forInnovation in Eye Care, in recognition of their development ofphotodynamic therapy for the treatment of wet AMD, bringing hopeto individuals facing blindness, and for being a significantstimulus for the development of treatment for all forms ofretinal degeneration. The award was presented at an exclusiveceremony held during the 2003 Association for Research in Visionand Ophthalmology (ARVO) annual meeting. Fort Lauderdale,Florida. Notes to Editors About VIM The multicenter VIM Trial assessed the potential benefit ofVisudyne therapy in 117 AMD patients with minimally classic CNVrandomized to one of three treatment arms: placebo; Visudynestandard fluence (light intensity) (600 mW/cm2); or Visudynereduced fluence rate (300 mW/cm2). At follow-up, resultssuggested that Visudyne therapy at either light fluence rate wasbeneficial in terms of vision outcomes: patients had anincreased chance of stable or improved vision. Patients in theVIM Trial will continue to be followed through 24 months.

About VIP

The VIP Trial, a phase IIIb clinical trial, consisted of anAMD and a pathologic myopia arm. The study included 258 patientswith subfoveal occult without classic CNV, who had recentdisease progression. The VIP Trial was conducted at 28 clinicalsites in Canada, United States, United Kingdom, France, Germany,Austria, Italy, Spain, Sweden and Switzerland between February1998 and September 2000.

About AMD

AMD is the leading cause of legal blindness in people overthe age of 50. Its associated vision loss has been shown tosignificantly decrease quality of life. Everyday tasks such asdriving and walking can be severely affected. Awareness of thecondition and treatment in the initial stages of the disease areessential for patients to take the necessary steps that lead todiagnosis and early treatment to halt progression of AMD.

Vision loss from AMD occurs in two forms: dry and wet. Thedry form is associated with atrophic cell death of the centralretina. The wet form is caused by growth of abnormal bloodvessels (CNV) under the central part of the retina or macula.These vessels leak fluid and blood and cause scar tissue thatdestroys the central retina. This results in a deterioration ofsight over a period of months to years. "Occult" and "classic"are terms used to describe the different patterns of CNV leakageas seen on fluorescein angiography. Classic CNV appears as awell-demarcated area of hyperfluorescence in the early-phaseframes of the angiogram. The boundaries of occult CNV are oftenpoorly defined or difficult to demarcate and often appears ashyperfluorescence in the late- phase frames of the angiogram.

About Visudyne

Visudyne therapy is a two-step procedure. Followingintravenous administration, Visudyne is activated by a non-thermal laser light. The process is known as photodynamictherapy. Visudyne selectively targets and immediately occludesabnormal blood vessels under the retina, resulting in a reductionin their growth, without affecting healthy retina tissue. This,in turn, stops the leakage associated with wet AMD. Through itsunique mode of action, Visudyne provides the chance to reducethe risk of visual acuity loss, to stabilize contrastsensitivity and thereby preserve quality of vision long term.

Visudyne is the only drug approved for the treatment of someforms of wet AMD, the leading cause of blindness in people overthe age of 50, and has been used in more than 250,000 patientsworldwide. Recent clinical data show evidence in its efficacyand safety though a treatment period of up to 5 years. Visudyneis commercially available in more than 70 countries for thetreatment of predominantly classic subfoveal CNV and in over 36countries for occult subfoveal CNV caused by AMD. It is alsoapproved in more than 55 countries, including the EU, U.S. andCanada, for the treatment of subfoveal CNV due to pathologicmyopia (severe near-sightedness). In some countries Visudyne isalso approved for presumed ocular histoplasmosis or othermacular diseases.

Visudyne is generally well tolerated and has an excellentsafety profile. Potential side effects include injection sitereactions, back pain, blurring, decreased sharpness and gaps invision, and in one - five per cent of patients, a substantialdecrease in vision with partial recovery. After treatment,patients should avoid direct sunlight for five days to avoidsunburn. People with porphyria should not be treated. For moreinformation visit www.visudyne.com.

Visudyne(R) is a trademark of Novartis AG.

The foregoing press release contains forward-lookingstatements that can be identified by terminology such as"extremely promising", "expect further demonstration", or bydiscussions regarding the evaluation of early trial data orpotential new indications or treatment methods for existingproducts. Such forward-looking statements involve known andunknown risks, uncertainties and other factors, which may causethe actual results and assumptions to be materially differentfrom any future results, performance or achievements expressedor implied by such statements. Such factors include, but are notlimited to: risks associated with the development andcommercialization of the treatment, including uncertaintiesrelating to manufacturing, clinical trials, registration,pricing and reimbursement; patient and physician demand for thetreatment; competition; any uncertainty regarding patents andproprietary rights; outcome of litigation claims, productliability claims and insurance; government regulation; anti-takeover provisions; dependence on corporate relationships;volatility of share prices; and additional information and otherfactors as described in detail in Novartis AG's Form 20-F, andother filings with the US Securities and Exchange Commission.

Background on Novartis

Novartis Ophthalmics: With worldwide headquarters in Bulach,Switzerland, Novartis Ophthalmics is a global leader inresearch, development and manufacturing of leading ophthalmicpharmaceuticals that assist in the treatment of age-relatedmacular degeneration, eye inflammation, glaucoma, ocularallergies and other diseases and disorders of the eye. NovartisOphthalmics products are available in more than 110 differentcountries. The North American headquarters is based in Atlanta,Georgia. Novartis Ophthalmics products are made in Switzerland,France and Canada. For more information, visitwww.novartisophthalmics.com or www.novartisophthalmics.com/us.

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticalsand consumer health. In 2001, the Group's businesses achievedsales of CHF 32.0 billion (USD 19.1 billion) and a net income ofCHF 7.0 billion (USD 4.2 billion). The Group investedapproximately CHF 4.2 billion (USD 2.5 billion) in R&D.Headquartered in Basel, Switzerland, Novartis Group companiesemploy about 74,000 people and operate in over 140 countriesaround the world. For further information please consulthttp://www.novartis.com.

QLT Inc. (Nasdaq:QLTI; TSE: QLT) is a global pharmaceuticalcompany specializing in the discovery, development andcommercialization of innovative therapies to treat cancer, eyediseases and niche areas for which treatments can be marketed bya specialty sales force. Combining expertise in ophthalmology,oncology and photodynamic therapy, QLT has commercialized twoproducts to date, including Visudyne therapy, which is the mostsuccessfully launched ophthalmology product ever. For moreinformation, visit our web site at www.qltinc.com

References

1 Bressler N et al, A Phase II Placebo-Controlled, Double-Masked, Randomized Trial - Verteporfin in Minimally Classic CNVdue to AMD (VIM), ARVO Annual Meeting, Ft. Lauderdale, Florida,May 4-8, 2003. Abstract.

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