Periodic Reporting for period 3 - GLAUrious (External Automatic Glaucoma Laser (EAGLE) for the first-line glaucoma treatment:Commercial prototype development and validation)
Berichtszeitraum: 2019-03-01 bis 2020-02-29
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. This disruptive technology is focused on transforming the conventional glaucoma management from a specialized procedure, into one that is effective, safe and reliable that can be carried out by every ophthalmologist and other eye care providers as a first-line treatment.
The only treatment for glaucoma and ocular hypertension (OHT) is reduction of IOP. Direct Selective Trabeculoplasty (DSLT) by EAGLE device does exactly that, however unlike eye drops that depend on patient compliance, which is very poor, and unlike other glaucoma procedures, which require expertise, the new laser procedure can be operated by any eye care provider, in any location. It will pose an alternative to eye drops, or at the very least will be used in conjunction with, as a common practice. This holistic approach combining both laser and drugs will ensure controlled IOP, non-dependent on patient’s compliance with minimum fluctuations.
We address the growing disparity between the enormous number of glaucoma patients and the limited number of ophthalmologists, by enabling many more eye care practitioners to treat many more patients.
130 million people worldwide suffer from glaucoma and OHT. However, there are just 200,000 ophthalmologists, and 6,000 glaucoma specialists to treat them. Only high-end technology can bridge this gap. The technology developed by the consortium partner BELKIN Laser is exclusively designed to provide an intuitive, easy and fast application of glaucoma laser treatment. The procedure can be operated by any eye-care provider, dramatically increasing the number of treated patients, both in central and rural areas, representing a compelling target market for this technology.
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. The multidisciplinary GLAUrious Consortium, with its five partners QUB (Queen's University Belfast), BEL (BELKIN Laser Ltd), FLC (Frankfurt Laser Ltd), UNIGE (University of Genoa), MCI (MCI bvba) from four-member states (Belgium, Italy, UK, Germany) and one associated state (Israel), incorporates three SMEs and two academic hospitals.
Successful validation of EAGLE will result in its commercialization enabling substantial ophthalmic market expansion.
The only treatment for glaucoma and ocular hypertension (OHT) is reduction of IOP. Direct Selective Trabeculoplasty (DSLT) by EAGLE device does exactly that, however unlike eye drops that depend on patient compliance, which is very poor, and unlike other glaucoma procedures, which require expertise, the new laser procedure can be operated by any eye care provider, in any location. It will pose an alternative to eye drops, or at the very least will be used in conjunction with, as a common practice. This holistic approach combining both laser and drugs will ensure controlled IOP, non-dependent on patient’s compliance with minimum fluctuations.
We address the growing disparity between the enormous number of glaucoma patients and the limited number of ophthalmologists, by enabling many more eye care practitioners to treat many more patients.
130 million people worldwide suffer from glaucoma and OHT. However, there are just 200,000 ophthalmologists, and 6,000 glaucoma specialists to treat them. Only high-end technology can bridge this gap. The technology developed by the consortium partner BELKIN Laser is exclusively designed to provide an intuitive, easy and fast application of glaucoma laser treatment. The procedure can be operated by any eye-care provider, dramatically increasing the number of treated patients, both in central and rural areas, representing a compelling target market for this technology.
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. The multidisciplinary GLAUrious Consortium, with its five partners QUB (Queen's University Belfast), BEL (BELKIN Laser Ltd), FLC (Frankfurt Laser Ltd), UNIGE (University of Genoa), MCI (MCI bvba) from four-member states (Belgium, Italy, UK, Germany) and one associated state (Israel), incorporates three SMEs and two academic hospitals.
Successful validation of EAGLE will result in its commercialization enabling substantial ophthalmic market expansion.
"Main results achieved during the project:
1. Partner BEL has completed the hardware and software design, integration and validation of EAGLE clinical prototypes. The device electrical, laser safety and software validation were performed to meet the Essential requirements and EU regulations.
2. Pre-clinical evaluation: Successful device performance achieved, all treated eyes of Dutch Belted rabbits as well as the control eyes showed normal histology with no changes.
3. First-in Human Clinical trial has been completed at Sheba Medical Center, Israel. The results suggest that the automated DSLT seems to be a safe and effective method of reducing intra-ocular pressure (IOP) in open-angle glaucoma. The results of the study are submitted for review at Ophthalmology, one of the leading ophthalmology journals.
4. 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 (at Belfast City Hospital) and UNIGE (at the Eye Clinic, Genova University), and clinical subcontractors, Moorfeilds Eye Hospital (UK) and Beilinson Hospital (Israel). The study was approved by regulatory and ethical authorities in UK, Italy and Israel (ISRCTN registry #14033075, clinicaltrials.gov # NCT03750201).
5. GLAUrious study has been initiated in Italy in Eye Clinic, University of Genova (partner UNIGE), Belfast Hospital (partner QUB) and in Moorfeilds Eye hospital. 40 patients were recruited during the course of the study, 27 underwent the treatment. No Serious Adverse Events were reported. The trial will continue after the course of the project.
6. During the course of the project, the commercial prototype of EAGLE device has been produced to validate the device sub-systems performance. Based on the verification and validation results, an additional design cycle will be performed for manufacturing of the final commercial prototype. If no foundations for design updates are found, it will be used for the completion of the final commercial system manufacturing file and the commercial system production towards CE approval and the product launch.
7. Exploitation and dissemination activities: the commercial device development has led to three new patent applications to protect IP covering DSLT device, its image-processing algorithms and safety features. During the project, the method’s concept and the results of the FIH study have been presented at several Bio-optics and Ophthalmology conferences. Two manuscripts have been prepared for publication:
1). Submitted for review: Mordechai Goldenfeld, Michael Belkin, Masha Dobkin-Bekman, Zachary Sacks, Sharon Blum Meirovitch, Noa Geffen, Ari Leshno, Alon Skaat. Automated Direct Selective Laser Trabeculoplasty:
First-in-Human Prospective Clinical Trial, 2020 (submitted for review, Ophthalmology, 2020).
2). Published : Zachary Sacks, Masha Dobkin-Bekman, Noa Geffen, Mordechai Goldenfeld, Michael Belkin, Non-contact direct selective laser trabeculoplasty: light propagation analysis. Biomed. Opt. Express 11, 2889-2904 (2020)."
1. Partner BEL has completed the hardware and software design, integration and validation of EAGLE clinical prototypes. The device electrical, laser safety and software validation were performed to meet the Essential requirements and EU regulations.
2. Pre-clinical evaluation: Successful device performance achieved, all treated eyes of Dutch Belted rabbits as well as the control eyes showed normal histology with no changes.
3. First-in Human Clinical trial has been completed at Sheba Medical Center, Israel. The results suggest that the automated DSLT seems to be a safe and effective method of reducing intra-ocular pressure (IOP) in open-angle glaucoma. The results of the study are submitted for review at Ophthalmology, one of the leading ophthalmology journals.
4. 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 (at Belfast City Hospital) and UNIGE (at the Eye Clinic, Genova University), and clinical subcontractors, Moorfeilds Eye Hospital (UK) and Beilinson Hospital (Israel). The study was approved by regulatory and ethical authorities in UK, Italy and Israel (ISRCTN registry #14033075, clinicaltrials.gov # NCT03750201).
5. GLAUrious study has been initiated in Italy in Eye Clinic, University of Genova (partner UNIGE), Belfast Hospital (partner QUB) and in Moorfeilds Eye hospital. 40 patients were recruited during the course of the study, 27 underwent the treatment. No Serious Adverse Events were reported. The trial will continue after the course of the project.
6. During the course of the project, the commercial prototype of EAGLE device has been produced to validate the device sub-systems performance. Based on the verification and validation results, an additional design cycle will be performed for manufacturing of the final commercial prototype. If no foundations for design updates are found, it will be used for the completion of the final commercial system manufacturing file and the commercial system production towards CE approval and the product launch.
7. Exploitation and dissemination activities: the commercial device development has led to three new patent applications to protect IP covering DSLT device, its image-processing algorithms and safety features. During the project, the method’s concept and the results of the FIH study have been presented at several Bio-optics and Ophthalmology conferences. Two manuscripts have been prepared for publication:
1). Submitted for review: Mordechai Goldenfeld, Michael Belkin, Masha Dobkin-Bekman, Zachary Sacks, Sharon Blum Meirovitch, Noa Geffen, Ari Leshno, Alon Skaat. Automated Direct Selective Laser Trabeculoplasty:
First-in-Human Prospective Clinical Trial, 2020 (submitted for review, Ophthalmology, 2020).
2). Published : Zachary Sacks, Masha Dobkin-Bekman, Noa Geffen, Mordechai Goldenfeld, Michael Belkin, Non-contact direct selective laser trabeculoplasty: light propagation analysis. Biomed. Opt. Express 11, 2889-2904 (2020)."
The project goal was to clinically validate the innovative and revolutionary EAGLE device for use as a first-line treatment for glaucoma, and to finalize the development of a cost-effective commercial EAGLE device.
The project’s developmental path was 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 clinical trials, 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.
The project’s developmental path was 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 clinical trials, 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.