Community Research and Development Information Service - CORDIS

H2020

GLAUrious Report Summary

Project ID: 720274

Periodic Reporting for period 1 - GLAUrious (External Automatic Glaucoma Laser (EAGLE) for the first-line glaucoma treatment:Commercial prototype development and validation)

Reporting period: 2016-09-01 to 2017-08-31

Summary of the context and overall objectives of the project

The GLAUrious project is clinically testing and validating the novel External Automatic Glaucoma Laser (EAGLE) device developed and patented by BELKIN Laser Ltd with the goal of providing accessible first-line treatment for glaucoma. About 64 million people worldwide suffer from glaucoma Which is a chronic disease causing progressive optic nerve degeneration, is the leading cause of irreversible blindness globally. Although incurable, disease progression can be arrested or delayed by reducing the pressure inside the eye, thus preventing visual incapacitation and blindness.
Current first-line treatment requires life-long daily eye drops, a strict regimen causing 50% patient dropout after 1 year. Laser treatment for glaucoma (Laser Trabeculoplasty, LTP) has been in use for many years. Its effect lasts for 2−5 years and is repeatable. This traditional 10-minute procedure, involving contact with the patient’s eye, requires the expertise of glaucoma specialists. Consequently, costs are high and accessibility to the general population is low. The novel EAGLE procedure is automated, non-invasive, non-contact, painless and user friendly—1 second of treatment by one press of a button. This revolutionary cost-effective device could be safely used by all the world’s 212,000 ophthalmologists, thus becoming a primary treatment for glaucoma, overcoming serious problems of eye drop non-compliance and non-availability, thus effectively preventing disease deterioration. GLAUrious project aims to facilitate commercialization of the EAGLE device by securing clinical prototype validation, streamlining industrial production, optimizing component costs, disseminating to key opinion leaders and distributors, and refining commercial strategy. Validation of EAGLE will allow its commercialization within 3 years of project initiation, enabling penetration of the ophthalmic market and boosting of the industrial consortium partners (BELKIN Laser, Frankfurt Laser Company and Medical Consulting and Investment Company). The multidisciplinary GLAUrious Consortium, with its five partners from four member states (Belgium, Germany, Italy, UK) and one associated state (Israel), incorporates three SMEs and two academic hospitals.
The External Automatic Glaucoma Laser (EAGLE) device has been developed and patented by BELKIN Laser (partner BEL) with the vision of providing a world-wide, cost-effective solution that enables an accessible first-line choice of treatment for glaucoma by an innovative one-second automatic laser treatment for the benefit of both ophthalmologists and patients. This novel, non-contact method directs the beams deep into the sclera (the white part of the eye) around the limbus (the border between the colored and the white parts of the eye), a location which overlies the target tissue (trabecular meshwork). The instrument delivers 100 laser applications automatically and simultaneously. This will enable treatment by this novel cost-effective device to be completed in less than one second in an automatic mode implementing image-acquisition technology, and could be performed by any ophthalmologist, not only glaucoma specialist.

The GLAUrious consortium aims to complete the final steps in development of the EAGLE device, namely clinical validation of the prototype, commercial prototype production by cost optimization of components, dissemination to key opinion leaders and distributors, and refinement of the commercial strategy. Successful validation of EAGLE will result in its commercialization enabling, on one hand, substantial penetration by this innovative product of the ophthalmic market, and on the other hand boosting growth of the industrial consortium partners (BEL, FLC and MCI).
The objective of GLAUrious is to modify the therapeutic algorithm of glaucoma in such a way that a glaucoma patient attending a community ophthalmologist for initial treatment of glaucoma can receive laser treatment as the first option. In this way it wil

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

"The main objectives of the first reporting period included: 1. Clinical prototypes production and 2. Clinical trial submission package preparation for UK and Italy authorities for clinical trial approval.
Main results achieved:
1. Partner BEL has completed the hardware and software design, integration and validation of EAGLE clinical prototype. The device electrical, laser safety and software validation were performed to meet the Essential requirements and EU regulations.
2. Project partners and medical advisors developed the clinical protocol of the multicenter randomized, controlled, masked study to demonstrate non-inferiority of Direct Selective Laser Trabeculoplasty (DSLT) compared to Selective Laser Trabeculoplasty (SLT) to be performed by partners QUB and UNIGE. The primary effectiveness endpoint is the difference between the two treatment groups between the mean (washed out for medicated patients) baseline intraocular pressure (IOP) and the mean (washed out for medicated patients) IOP measured at 6 months. Secondary Effectiveness Endpoints: i. Mean percentage reduction in IOP at 3, 6 and 12 months. ii. Number of medications at 12 months as compared to measurement before treatment and compared between groups. Exploratory endpoints include: 1. Physician perception of the usability of the system, and ii. Participant reported subjective experience. Adverse events will be monitored. The study is registered at ISRCTN registry (# 14033075).
The protocol, informed consent, investigator brochure and other clinical trial related documentation needed for the regulatory approval of the study were submitted in UK to Northern Ireland to North West - Greater Manchester West Research Ethical Committee, Medicines and Healthcare products Regulatory Agency (MHRA) and to the Research Office Belfast HSC Trust; the approval was already provided by the Ethical Committee and the conditional approval by MHRA is pending the submission of several additional software validation reports. In Italy the clinical trial approval bundle was submitted to Liguria Ethical Committee and to the Ministry of Health. The study is already approved by both authorities.

"

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The project will clinically validate the innovative and revolutionary EAGLE device for use as a first-line treatment for glaucoma, and finalize the development of a cost-effective commercial EAGLE device.
The project’s developmental path is devised to finalize the regulatory requirements for CE mark authorization prior to commercialization of a medical device in the EU. A CE mark, together with the clinical data obtained in the multicenter clinical trial, will support the market penetration.
At present, only a small minority of glaucoma patients are aware of the possibility of undergoing traditional laser irradiation as an initial treatment instead of enduring years of medical treatment. EAGLE is designed to make glaucoma laser treatment accessible through general ophthalmologists.
The innovative technology provides a solution not only for Open Angel Glaucoma (OAG, 74% of total glaucoma cases) but may also serve as an exclusive solution for Angle Closure Glaucoma (ACG, ~26%). ACG is most common among East Asian and Indian populations and is the leading cause of irreversible blindness in China.

Related information

Follow us on: RSS Facebook Twitter YouTube Managed by the EU Publications Office Top