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    LHON therapy: Excellent safety and potential visual benefits


    “No deaths or adverse events leading to study discontinuation occurred. No systemic or serious adverse events occurred that were related to GS010 or the study procedures,” Dr. Sahel reported. One serious adverse event that was not related to the injection, i.e., thoracic pain 7 to 8 months following the injection, occurred.

    Fifty-seven ocular treatment-related adverse events occurred, the most common of which was ocular inflammation in 24 eyes; 13 adverse events were related to the study procedure, the most common of which were increased intraocular pressure (IOP) and keratitis. All treatment-related events were considered mild with the exception of four: two moderate IOP increases, one case of severe anterior chamber inflammation, and one case of severe vitreous inflammation.

    All IOP increases either resolved spontaneously or with topical therapy. Dr. Sahel pointed out that the injection volume has decreased to 90 microliters from 180 microliters in the phase III trials. The cases of inflammation all responded to topical anti-inflammatory therapy, except for one patient treated with an oral medication.

    “The preliminary results of the secondary endpoints showed that there was a beneficial non statistically significant trend (p=0,06) in VA improvement in patients treated sooner than 2 years after the disease onset compared with patients treated more than 2 years after the disease onset,” Dr. Sahel reported.

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