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Ocular Research By Integrated Training And Learning

Periodic Reporting for period 1 - ORBITAL (Ocular Research By Integrated Training And Learning)

Reporting period: 2019-09-01 to 2021-08-31

Diseases of the posterior segment of the eye are rapidly increasing, partly due to an ageing population (~20% of Europe’s population now over 65), which affects the entire EU. One such condition, Age-Related Macular Degeneration (AMD), is a leading cause of blindness in people over 50, and the number of Europeans some form of AMD is expected to increase to 77 million by 2050. In the case of Diabetic Retinopathy (DR), as many as 28 million Europeans could suffer from visual impairment due to this disease alone. As such, ORBITAL aims to aid management of complications associated with such chronic diseases. Despite accounting for approximately 55% of ocular conditions, significantly less than half of ocular product sales target the posterior segment due to the technical difficulties in developing safe, effective and easy-to-use formulations. These diseases represent a considerable and growing burden on patients and healthcare systems throughout the world and given the statistics, there is a worrying lack of researchers with the necessary interdisciplinary skills being trained to combat such increasing burdens. Thus, ORBITAL’s intrinsic training expertise makes it a vital tool in bridging this particular skills gap.
The ORBITAL ETN focuses on the enhanced delivery of drugs for the treatment of posterior segment diseases of the eye. Currently, there are several established drug delivery routes to the back of the eye, but all pose potential problems. As such, there is a pressing need for the development of advanced drug delivery techniques.
With a uniquely qualified and outstanding collaborative network of European and global experts, from academic, clinical and industrial sectors, ORBITAL is training ESRs in materials science, nanotechnology, animal modelling, enhanced in-vitro testing, in-vivo ocular modelling, analytical chemistry and drug discovery, all under the overarching principle of drug delivery. Engagement with patients, patient groups and clinicians, throughout the entirety of the training programme will ensure that patient-oriented solutions are at the centre of all research activity. With this multi-pronged approach, ORBITAL will establish itself as a leader in innovative ocular drug delivery technology that is both patient-centered and industry disrupting.
ORBITAL has divided its research into three scientific work packages, which are currently being carried out in state of the art research facilities in Europe, the US, and Canada. The goals of the work packages are described below:

• Work package 3 (WP3) ENHANCED MEDICAL DEVICES: In this WP, ESRs will develop novel, biocompatible polymeric materials to prepare platforms and medical devices to improve the delivery of drugs to the posterior segment of the eye. Innovative approaches to enhance the residence time and bioavailability of therapeutics, overcome the drug transport barriers of the eye and develop enhanced drug-depot capabilities for implantable materials will be used, all in a patient-centric, safe and efficient manner.
o During this reporting period, a report on mathematical modelling to determine the drug release profiles from novel polymeric materials was completed, followed by a report on the physical and chemical characterisation of preliminary medical devices prepared within the work package.
o Additionally, a selection of monomers and polymers for drug delivery platforms was established.

• Work package 4 (WP4) – INNOVATIVE NANOFORMULATIONS: Here, the ESR focus is on developing innovative formulations that will enhance traditional topical delivery strategies (e.g. eye-drops and sprays) for ocular therapeutics, thereby enabling delivery of drugs to the back of the eye through application at the front of the eye. This will be done by overcoming drug residence time issues, improving drug bioavailability and developing nanomaterials to transport drugs across the physiological barriers of the eye.
o During the reporting period, a report on mathematical modelling to determine target drug release profile from novel nanomaterials for use in this work package, and a follow-up report on preliminary nanomaterial formulation development, including drug encapsulation/loading & particle size in the WP was submitted.
o Finally, the ideal nanomaterial components for the formulations were identified.

• Work package 5 (WP5) - DEVELOPMENT OF ENHANCED OCULAR MODELS: In WP5, ESRs will develop new in vitro and ex vivo models to closer mimic ocular physiological conditions and thereby focus research effort on technologies that are most likely to perform effectively for patients. New in vivo models will be developed for disease states that will allow improved identification of drugs and drug delivery technologies for the treatment of PSD, all with the focus of expediting the development of novel technologies for the treatment of such diseases and with a view to future reduction in the need for animal studies.
o In this reporting period, a report on the physical and chemical characterisation of drug delivery platforms for use in ocular models was produced, followed by a report on the initial development of enhanced ex-vivo models for rapid technology screening using novel colloidal formulations.
o Additionally, enhanced ex-vivo models were designed, and an in vitro model was confirmed as optimum for advanced biomarker screening.
The impact of the research from ORBITAL cannot be overstated. With the prevailing impact of PSD on aging populations globally, the ORBITAL ITN stands to make a significant impact on the treatment of PSD and the overall affordability and accessibility for patients. By the end of the project, the expected results are:
• Biocompatibility of preliminary drug delivery platforms will be tested by in vitro methods, and safety and efficacy of the platforms will be determined in pre-clinical models;
• Ocular complications of Diabetic Retinopathy will be mimicked in an in vivo rat model;
• Stability of biocompatibility of nanoformulations will be confirmed.
Potential Impact:
• Because of the prevalence of PSD including DR and AMD, the quality of life for patients seeking alternative, less invasive treatment methods would vastly improve;
• ORBITAL has a focus on the Patient and Public Involvement on research, and the input from the key recipients of any ocular therapeutic technology ensures that ORBITAL is on track not just to disrupt the current ocular therapeutic industry, but in a way that is useful and wanted by those in need of novel treatments;
• ORBITAL will ensure that 15 researchers exit the programme trained in Ocular Drug Delivery, ready to enter the field with skills in innovation, entrepreneurship, lab sciences, and help to accelerate the development of novel drug discovery and delivery technology for PSD.
ORBITAL ESRs throughout the first two years, on secondment, in labs, and in online workshops