1. Our vision
  2. New data on PRESERFLO® MicroShunt presented by Santen at World Glaucoma Congress

New data on PRESERFLO® MicroShunt presented by Santen at World Glaucoma Congress

Wed 28 June 2023

Press release for specialist healthcare professional and trade
  • Safety data on PRESERFLO® MicroShunt shows comparable incidence of  Endothelial Cell Density loss vs trabeculectomy.1
  • New data adds to body of evidence for PRESERFLO® MicroShunt (more details can  be found below).

28 June 2023 - Geneva, Switzerland – Santen, a global specialist in ophthalmology, will  share new long-term data on PRESERFLO® MicroShunt at the World Glaucoma Congress  (WGC) – taking place in Rome, Italy from June 28 to July 1, adding to the body of evidence  for PRESERFLO MicroShunt. Overall, Santen is committed to bringing continuous innovation for glaucoma patients, providing a comprehensive treatment portfolio from drops to surgery  to meet patients’ needs.

Santen is presenting data in a poster (P-437) at WGC from an ongoing Open-Label  Extension Study on PRESERFLO® MicroShunt (INN005) confirms that Endothelial Cell  Density (ECD) loss at 4 years post-implantation is similar in patients implanted with  PRESERFLO® MicroShunt and those who received trabeculectomy.1 At month 48, the mean  percentage ECD loss from screening was -16.2 and -13.9, respectively (p=0.498).1 Over the  same time period, both groups had a similar number of patients with an ECD of <1000  cells/mm2 (7.9% and 7.0%, respectively).1

“The risk of Endothelial Cell Density (ECD) loss has long been a concern of surgeons  implanting glaucoma stents.” comments Professor Henny Beckers from the University Eye  Clinic, Maastricht. “This data four years on from PRESERFLO® MicroShunt surgery is  reassuring for both surgeons and patients about the longer-term implications of their  treatment.”

Santen will also present a poster (P-433) on the 2-year data from the INN005 study, showing  that rates of post-operative interventions were lower with PRESERFLO® MicroShunt vs  trabeculectomy (55.4% vs 70.1%; p=0.001).2 Late complications of hypotony were  significantly higher in the trabeculectomy group (20.6% vs 9.1%; p=0.0026).2 However,  needling and reoperation rates were higher in the group implanted with PRESERFLO® MicroShunt.2

There will also be a talk on the Santen stand (Friday, June 30 at 16:45 CEST) by glaucoma  surgeon Professor Ike Ahmed, who will share findings from a recently published study  including 3-year retrospective data from a large cohort of PRESERFLO® MicroShunt patients  with mitomycin C (MMC) (n=135).± Complete success* was achieved in 55.6% of patients;  59.4% of patients were medication free 3 years after PRESERFLO® MicroShunt surgery.3

In addition to Santen presenting the data above in poster form, they will also host two  symposia at WGC:

  • Navigating The Evolving Treatment Paradigm: New insights to meet the diverse  needs of patients with glaucoma – Auditorium, Wednesday, June 28 – 13:15-14:15 CEST
  • Crossing New Frontiers: Global solutions in glaucoma management – Room B,  Thursday, June 29 – 18:00-19:00 CEST

Ioana Grobeiu, Head of Medical Affairs at Santen comments: “This year’s WGC is the first in person worldwide congress for glaucoma since COVID-19, which makes it a unique  opportunity for face-to-face interactions. We are delighted to bring clinicians up to date on  the latest evidence for our therapies through a range of symposia and poster presentations  and to discuss the implications for patient care.”

+++

± Santen does not endorse use of PRESERFLO MicroShunt outside its indication.

*Complete success defined as eyes:

  • With no two consecutive IOPs >17 mmHg and no significant hypotony
  • With ≥20% reduction from baseline IOP
  • Using no glaucoma medications
References

  1. García-Feijoó J. MicroShunt vs Trabeculectomy: Interim Safety Observations From an Ongoing Open Label Extension Study in Patients With Primary Open-Angle Glaucoma.

  2. García-Feijoó J. Postoperative Complications and Reoperations for Glaucoma in MicroShunt vs  Trabeculectomy Study During 2-year Follow-up.

  3. Armstrong JJ et al, Ophthalmol Glaucoma. 2023 Apr 10;S2589-4196(23)00067-4. doi:  10.1016/j.ogla.2023.04.002. Online ahead of print.

About Santen

As a global specialised company dedicated to ophthalmology, Santen carries out research,  development, marketing, and sales of pharmaceuticals, over-the-counter products, and  medical devices that benefit patients in over 60 countries. Santen’s long-term vision is to  become a social innovator in ophthalmology and address social and economic issues related  to eye health by strategically exploring advancing technologies and collaborating with key  leaders around the world. Underpinned by its people-centric values, Santen aims to  ultimately deliver happiness with vision – a life with the best vision experience for every  individual around the world. With scientific knowledge and organisational capabilities  nurtured over 130 years, Santen provides products and services to contribute to the well being of patients, their loved ones and consequently to society. For more information, please  visit Santen’s websites www.santen.eu (Europe, Middle East and Africa, EMEA) and  www.santen.com (Japan headquarters).

Media contact: 

Jon Pike 
E: jon@mearnsandpike.com 
T: +44 7825 889607
 

PRESERFLO MicroShunt Instructions for use can be downloaded here.

Adverse events should be reported. Reporting forms and information for UK can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Santen UK Limited at medinfo@santen.co.uk or telephone: 0345 075 4863.

Document number: NP-PMS-EMEA-0063
Date of preparation: Date of preparation: June 2023