Two-year data on use of Visudyne in Japanese patients described

FORT LAUDERDALE, Fla. — Photodynamic therapy has been safe and effective for 2 years in Japanese patients with subfoveal choroidal neovascularization due to age-related macular degeneration, according to the results of a study described here.

Yasuo Tano, MD, of the Japanese AMD Trial (JAT) study group, described the trial’s 24-month results at the Association for Research in Vision and Ophthalmology meeting.

He said the results confirm previous observations from the 12-month data in the study and support the use of PDT over an extended time period.

The JAT study helped pave the way for last year’s approval of Visudyne (verteporfin for injection, Novartis) in Japan for all forms of choroidal neovascularization (CNV) secondary to AMD. The Japanese government recently agreed to reimburse for Visudyne treatment, an announcement that Dr. Tano said was long awaited.

“These results confirm the safety and efficacy of this modality and are consistent with the efficacy observed in previous studies. These results have finally led to the approval of verteporfin therapy in all lesion compositions of CNV secondary to AMD in Japan,” he said.

Fifty-one patients were enrolled in the 24-month JAT study, out of the 61 patients who were enrolled in the 12-month phase. Those who enrolled in the trial extension received additional verteporfin therapy — a mean of 0.9 treatments during the second 12 months — through month 21 if fluorescein leakage from CNV was seen on angiography, according to Dr. Tano.

Forty-six patients (90%) completed the 24-month evaluation. Treatment was discontinued in five patients due to adverse events that were not considered related to the treatment, he said. At month 24, the mean visual acuity score in the study eye was 54.0, compared to 50.8 at baseline and 54.2 at 12 months. Dr. Tano said the score of 54.0 equated to about 20/80 in the scale used in the JAT study.

At the end of the study, six of 46 patients had lost 15 letters of visual acuity or more, and four of those six patients had lost 30 letters or more, Dr. Tano said.

Dr. Tano said he believes this approval of Visudyne will dramatically impact the way Japanese vitreoretinal specialists approach the treatment of CNV secondary to AMD.

“[PDT] is very beneficial to Asian populations. Currently, [transpupillary thermotherapy] is more heavily used in Japan that it is in the United States, but I believe that this will change,” he said.