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    Sustained-release topical rings promising for glaucoma

    Study aims to compare effectiveness, safety of rings versus eye drops

     

    Solving adherence problems

    Because the ring is replaced at the regular office visits by a patient’s eye care provider, the patient does not need to struggle with taking or remembering to take daily drops. The bimatoprost ring contains 13 mg of bimatoprost mixed into a silicone matrix over an inner polypropylene ring ranging from 24 to 29 mm in diameter; the different diameters allow a custom fit for each patient based on their measured intercanthal distance. The ring elutes a continually declining dose of bimatoprost starting at about 35 µg/day at day 0 (day of insertion) and reaches about 6 µg /day at day 180. To place a ring, the eye care provider gently uses his or her fingers to retract the eyelids and places the ring circumferentially in the upper and lower fornices.

    “The ring has been designed so that a doctor would size and apply the rings to start treatment, then replace them every six months at a regularly-scheduled follow-up visit,” Dr. Brandt said.

    To understand whether the rings could provide a better alternative for patients who face adherence challenges, the phase II study examined the safety and efficacy of the bimatoprost ring and compared them to eye drops as a control. Dr. Brandt and the investigators at nine additional clinical sites recruited 169 people with open-angle glaucoma or ocular hypertension.

    During the eye drop washout period at the start of the trial, each patient wore non-medicated rings bilaterally to assess comfort and fit. Of the 169 participants who wore the non-medicated rings, approximately 90% found the inserts comfortable. After the washout period, the investigators removed the non-medicated inserts from all the participants, then randomly assigned 64 patients to receive the medicated inserts and 66 to the control arm.

    This was a double-masked study – patients in the control arm wore non-medicated rings and used non-preserved timolol 0.5% ophthalmic solution twice a day; patients in the medicated group wore rings containing bimatoprost but also used non-medicated eye drops (packaged identically to the timolol to preserve masking) twice a day. Timolol was used in the control arm since it is the most frequently used comparator in regulatory studies of IOP-lowering drugs.

    Effectiveness

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