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    Ocular insert overcoming glaucoma treatment challenges

    Bimatoprost topical delivery system provides safe, well-tolerated, clinically relevant IOP lowering for 6 months

    Take-home message: A bimatoprost-releasing ocular insert that rests in the conjunctival fornix (ForSight VISION5) lowered IOP in patients with ocular hypertension or glaucoma by an average of 4 to 6 mm Hg from baseline over 6 months.

    By Cheryl Guttman Krader; Reviewed by James D. Brandt, MD

    Sacramento, CA—Results of a multicenter, randomized, double-masked phase II study demonstrate that a novel topical ocular insert (Helios, ForSight VISION5) providing sustained delivery of bimatoprost safely and effectively reduces IOP for a period of 6 months, said James D. Brandt, MD.

    The study enrolled 130 patients who were randomly assigned to placement of the bimatoprost ocular insert or twice-daily treatment with topical timolol maleate 0.5%. A double-dummy design was used to maintain masking so that the bimatoprost ocular insert group also received artificial tears twice daily and the timolol eye drop group underwent placement of a non-medicated insert.

    The insert is an investigational product in the United States.

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    Mean diurnal IOP calculated using measurements obtained at times 0, 2, and 8 hours at the 2-, 6-, and 12-week visits was assessed as the primary endpoint, and secondary endpoints analyzed mean diurnal IOP at 4, 5, and 6 months.

    Throughout the study, the bimatoprost ocular insert group maintained clinically relevant reductions in diurnal IOP in the range of 4 to 6 mm Hg.

    The novel treatment was well tolerated and had a safety profile consistent with topical bimatoprost, with no unexpected or unanticipated safety issues encountered.

    “There is a pressing need for patient-independent, sustained delivery of medications to prevent blindness from glaucoma,” said Dr. Brandt, professor of ophthalmology and director, glaucoma service, University of California Davis, Sacramento, CA. “I am very excited about this platform that is well-retained, tolerated, and potentially gives the ability to deliver multiple medications using a single system.”

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