Swiss drug major Novartis says that the first results of the RESTORE Phase III study show that ranibizumab is significantly more effective than laser treatment, the current standard of care, at treating visual impairment due to diabetic macular edema (DME), a serious complication of diabetes.
Novartis has a license to develop the compound in markets excluding the USA from fellow Swiss major Roche's subsidiary Genentech, which US retains rights to the product, already sold as Lucentis for the treatment of wet age-related macular degeneration (AMD). Lucentis generated first-quarter sales of $364 million for the Swiss group, up 43% year-on-year.
Results at one year show that 37% of patients treated with ranibizumab 0.5mg alone, and 43% of those treated with ranibizumab plus laser therapy, gained a substantial vision improvement of 10 letters or more on an eye-chart compared to 16% of patients treated with laser alone. The drug had a favorable safety profile when used as monotherapy with no new safety risks observed when combined with laser therapy.
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