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GenSight reports additional phase 3 data of GS010 for Leber hereditary optic neuropathy
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Additional data from GenSight’s REVERSE phase 3 clinical trial of GS010 for the treatment of Leber hereditary optic neuropathy show the single intravitreal injection met some secondary endpoints, according to a press release.
Topline results, which were reported in April, showed the treatment did not meet its primary endpoint of +15 ETDRS letters difference compared with sham-treated eyes but did meet secondary endpoints as defined by spectral-domain OCT parameters.
On further analysis, some secondary endpoints did not have significant or meaningful changes. Contrast sensitivity, however, almost doubled in treated eyes vs. sham eyes at 48 weeks.
Post hoc analyses of the trial also found those who entered the study with better vision tended to have better clinical outcomes, with an average gain in best-seeing eyes of +12 letters in the treated eyes compared with +4 letters in the sham eyes. In addition, patients younger than 21 years and those whose vision loss was less than 9 months had better results as well.
“Examining the totality of the data, the REVERSE results suggest a therapy that may provide meaningful bilateral improvement of vision for our subjects, which is not what would be expected from the natural history of this disease,” Barrett Katz, MD, chief medical officer at GenSight, said in the release. “GS010-treated eyes were significantly more likely to achieve vision of 20/200 or better when compared to sham-treated eyes. In addition, trends suggest a potentially larger benefit for subjects at earlier stages of LHON.”
All subjects will be evaluated again at 96 weeks, and data will be reported in the first quarter of 2019, the release said.