Results Published From 2-year Multicenter Study Illustrate Efficacy and Safety of Preserflo MicroShunt
Santen EMEA has announced the results from a 2-year multicenter study of the Preserflo MicroShunt in patients with primary open-angle glaucoma (POAG). The study showed that mean IOP was significantly reduced from 21.7±3.4 mmHg at baseline to 14.1±3.2 mmHg at year 2 (−34.1%), with no long-term sight-threatening adverse events (AEs) reported.[1] The study results have been published in Ophthalmology Glaucoma.
“We are really encouraged by these findings that are consistent with our previously-reported 1 year interim results,” Professor Florent Aptel, Centre Hospitalier Universitaire de Grenoble, France, said in a company news release. “Not only has the Preserflo MicroShunt reduced mean IOP, but it has reduced the need for topical anti-glaucoma medication, illustrating the positive impact that this procedure can have on treating glaucoma and improving patient outcomes.”
The prospective, multicenter, single-arm, open-label study (NCT02177123) was conducted in France, The Netherlands, Spain, and Switzerland for patients aged 18-85 years with POAG who were inadequately controlled on maximum tolerated therapy with medical IOP ≥18 and ≤35 mmHg. The per-protocol population consisted of 81 patients who were implanted with the Preserflo MicroShunt with topical mitomycin C (0.2-0.4 mg/mL) applied via LASIK sponges for 2-3 minutes. Key results from the study include:
Mean ± standard deviation IOP was reduced from 21.7±3.4 mmHg at baseline to 14.1±3.2 mmHg at year 2, representing a 34.1% reduction from baseline and an overall success rate (with or without glaucoma medication) of 74.1% at year 2
The number of glaucoma medications was significantly reduced from 2.1±1.3 at baseline to 0.5±0.9 at year 2 (P<0.0001)
At year 2, 73.8% of patients were medication free
In the intention-to-treat population, most common (≥3% of patients) AEs at year 2 included IOP increase (n=23), keratitis (n=9), transient hypotony (n=9), pain (n=4), hyphema (n=2) and leakage of wound site (n=3). Serious AEs at year 2 included an event requiring unplanned glaucoma-related surgical re-intervention (n=2), increased IOP (n=1), keratitis that required hospitalisation and medication (n=1), corneal ulcer (n=1), conjunctival dehiscence (n=1) and leakage of wound site (n=1)
“By demonstrating sustained reductions in IOP, alongside the low rate of postoperative interventions over the 2-year period, we hope to illustrate the important role that Preserflo MicroShunt can play in the long-term management of glaucoma,” said Luis Iglesias, Head of Santen EMEA. “At Santen, we believe seeing is integral to life and are committed to exploring innovative procedures, such as the PRESERFLOTM MicroShunt, to help patients to prosper and have the best vision experience.”
The Preserflo MicroShunt Glaucoma Drainage System is intended for reduction of IOP in eyes of patients with primary open angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery. [2] The device is manufactured from an inert biocompatible material called ‘SIBS’ or poly(styrene-block-isobutylene-block-styrene), which elicits minimal foreign body reaction and inflammation.3 SIBS was designed by Professor Leonard Pinchuk, Senior Vice President, Executive Principal Scientist and Polymer Engineer at InnFocus, Inc., a Santen company, who was awarded the 2019 National Academy of Engineering Russ Prize*, in recognition for his advancement of modern medicine and bioengineering.
*National Academy of Engineering – Fritz J. and Dolores H. Russ Prize: The Russ Prize recognises an outstanding bioengineering achievement in widespread use that improves the human condition.
References
Beckers HJM, et al. Ophthalmol Glaucoma 2021:S2589-4196(21)00179-4. Available at:
https://doi.org/10.1016/j.ogla.2021.07.008. Online ahead of print. PMID: 34329772
PRESERFLOTM MicroShunt glaucoma drainage system. Instructions for Use
Kerr NM, et al. Min Invas Glau Surg 2020;91-103. Available at: https://link.springer.com/chapter/10.1007/978-981-15-