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    Bimatoprost sustained-release implants: Potential new pathway for glaucoma patients

     

    Specifically, the mean overall IOP reductions from baseline through week 16 after the first implantation of the bimatoprost sustained-release device were 7.2, 7.4, 8.1, and 9.5 mm Hg with the 6-, 10-, 15-, and 20-microgram doses compared with an 8.4 mm Hg decrease in the pooled fellow eyes treated with topical bimatoprost. The IOP decreases in the study eyes reached significance (p ≤ .001).

    The investigators commented that 92% and 72% of the study eyes did not need rescue or retreatment by week 16 and month 6, respectively. The most common adverse event was transient conjunctival hyperemia (median duration of 5 days), which developed within 2 days after the implant was injected.

    In 24 eyes that did require another treatment to control IOP, the overall mean IOP reduction from the baseline IOP was 8.0 mm Hg through 16 weeks after the repeat bimatoprost sustained-release treatment. In those eyes, the IOP had to decrease by less than 20% compared with baseline after the first injection of the bimatoprost device at consecutive visits that were 1 or more weeks apart.

    In addition, these eyes could not have received previous rescue therapy with a topical IOP-lowering medication and the safety level was adequate with the first implant, according to Dr. Walters.

    The study investigators concluded based on their findings that the four doses of bimatoprost sustained-release were well tolerated and the decreases in IOP were comparable to those achieved with topical bimatoprost 0.03% in overall IOP reduction through week 16. In most patients, the implant successfully controlled the IOP for up to 6 months after implantation, and the second treatment in those patients who needed it showed similar efficacy. Most of the adverse effects were transient and associated with the actual injection process.

    The investigators believe that the interim results of the phase 1/2 trial support further clinical development of the glaucoma implant.

     

    Thomas R. Walters, MD

    E: [email protected]

    Dr. Walters is a consultant to Allergan. The phase 3 trial of the implant is currently under way. The bimatoprost sustained-release implant has not yet been approved by the FDA.

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