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Study: SnET2 improved vision in patients with occult lesions in AMD
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SANTA BARBARA, Calif. — The photodynamic therapy drug SnET2 provided a visual acuity benefit for patients with occult choroidal neovascularization in age-related macular degeneration, clinical trials have shown. The two phase 3 clinical trials also found a visual benefit for patients with mixed classic and occult CNV lesions, according to the drug’s developer, Miravant Medical Technologies.
Results of the trial were presented by several researchers at the American Society of Retinal Specialists meeting in San Diego. Their presentations were summarized in a Miravant press release.
Edgar L. Thomas, MD, and colleagues conducted a subgroup analysis of the phase 3 clinical data by lesion composition. The researchers found a positive treatment response with SnET2-treated patients compared with placebo patients. The visual benefit was statistically significant for patients with both predominantly occult and pure occult AMD lesions, Dr. Thomas said in the press release.
Baruch Kuppermann, MD, said SnET2 with photodynamic therapy significantly reduced the risk of vision loss in drug-treated AMD patients vs. placebo patients consistently over a 2-year follow-up, according to the release. Patients averaged 2.8 treatments, with 85% of those treatments occurring during the first 9 months.
The clinical trial data were derived from two randomized, placebo-controlled, parallel group phase 3 studies conducted at 60 U.S. ophthalmology centers, according to Miravant. All enrolled patients had choroidal neovascularization associated with wet AMD. Patients were followed for 2 years and evaluated for re-treatment every 13 weeks.
SnET2-PDT was submitted for U.S. regulatory approval on March 31. The Food and Drug Administration has agreed to fast-track the drug, according to Miravant.