Glaukos has been appointed as the exclusive distributor of the Preserflo MicroShunt (DE-128 MicroShunt Santen Pharmaceutical Co., Ltd) in Australia, New Zealand and the United States, subject to appropriate regulatory approvals, including approval from the Australian Therapeutic Goods Administration. The Preserflo MicroShunt is a minimallyinvasive, ab-externo surgical device that has been developed to treat primary open-angle glaucoma (POAG) – the most common form of glaucoma in people aged 40 years and older.
A prospective, randomised, controlled, singlemasked, multi-centre pivotal study assessed the safety and effectiveness of the device when used standalone, without concomitant cataract extraction. The study compared the MicroShunt implanted intraoperatively with 0.2mg/ml concentration of mitomycin C (MMC) against standard of care trabeculectomy with the same concentration of MMC. Topline results, announced in August 2019 by Santen, showed the majority of the subjects treated with the MicroShunt experienced a greater than, or equal to, 20% decline in intraocular pressure (IOP) at month 12, to an average of 14mmHg. Additionally, patients with the MicroShunt demonstrated a lower incidence of hypotony, bleb leaks and lens opacity compared to those treated with a trabeculectomy in the pivotal study.
Having implanted patients in Australia with the Preserflo MicroShunt as part of this study, Dr Nathan Kerr, from Eye Surgery Associates and the Centre for Eye Research Australia, is convinced of the benefits of the procedure over conventional surgery.
“The Preserflo MicroShunt uses the power of subconjunctival filtration to reduce IOP, the only modifiable risk factor in glaucoma, in a controlled and predictable way. The dimensions of the MicroShunt provide sufficient resistance to prevent IOP falling below 6mmHg at normal aqueous production. This provides greater safety and offers patients a fast visual recovery. The device is made of a biocompatible material called SIBS that elicits minimal inflammation, which helps tackle one of the biggest challenges in glaucoma surgery – wound healing. The goal is to provide safe and effective bleb-based surgery with fast visual recovery, comfort, and few postoperative interventions,” he said.
In Australia, Associate Professor Mitchell Lawlor implanted the first five Preserflo MicroShunts just over a year ago, however due to the COVID-19 pandemic, has been unable to proceed with further implants. He said all five initial patients were chosen because they were either high risk for trabeculectomy failure, or for postoperative hypotony.
Dr Lawlor reported that “none of the five patients have experienced any adverse event including hypotony over the first 12 months. Similarly, no patients have shown any glaucoma progression since the surgery… Further experience will help to determine which particular patients are likely to benefit from the PreserFlo shunt. As with any new device, longer term follow-up for safety and efficacy is imperative.”
Dr Lawlor is following the outcomes of all patients in the Fight Glaucoma Blindness! Registry, which will provide ongoing comprehensive real world data on safety and efficacy outcomes for the PreserFlo shunt.