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    Lesion size plays key role in squalamine eye drops therapy

    Combination approach may lead to improved visual function in some AMD patients

     

    CNV size

    When explaining the success of the combination therapy, Dr. Boyer pointed out that lesions described as classic CNV can be markedly different.

    “Using the term 'classic' may not define the effectiveness of the drug,” he said.

    An evaluation of the size of the occult lesions and the visual outcomes identified the important factor. In patients with occult CNV less than 10 mm2 the patients had a 5.3-letter improvement with the combination therapy. The smallest occult lesion sizes were seen to have the best visual acuity results.

    Squalamine had a good safety profile and was generally well tolerated. Two patients who received squalamine dropped out of the study because of eye swelling and pain. No serious or severe adverse effects occurred.

    “The Impact Study showed robust gains in vision with the combination of OHR-102 and ranibizumab for treating classic lesions,” Dr. Boyer said. “Eighty percent of the lesions were classic with occult CNV less than 10 mm2 in size. The size of the occult component was the most important factor that drove the gains in visual acuity.”

    A 2-year phase III study of 650 patients is starting to evaluate treatment of patients with treatment-naive occult CNV that is less than 10 mm2. Patients will be treated with ranibizumab and then randomized to the active topical drop twice daily or the vehicle.

     

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