Development of next-generation Intraocular lens combined with degradable drug delivery system toward prevention of Posterior Capsule Opacification

A cataract is an ophthalmic disease in which a normal clear eye lens becomes cloudy or opaque, leading to a decrease in vision. The eye lens is responsible for focusing light and producing a clear image on the retina at the back of the eye. Cataracts are typically an ongoing process of healthy ageing, but seldom develop rapidly. Cataracts are responsible for more than 51% of the world's blindness. In 2010, the WHO estimated that 20 million people were suffering from cataracts and that the prevalence is estimated to double, reaching 40 million in 2020. There are more than three million cataract surgeries performed in the US annually. The prevalence of age-related cataract increases with age; the average age of a cataract patient is approximately 68 years in the US, and 50 and 65 in China and the UK, respectively.

Cataracts are treated surgically by replacing the natural clouded lens with an artificial lens. During the procedure, the new lens is inserted into the remaining capsule, housing the new lens, and restoring visual acuity. Unfortunately, secondary blindness, also termed "secondary cataract" develops in a significant proportion of patients due to a wound-healing response known as posterior capsule opacification (PCO). Presently, the most common and effective treatment of PCO is laser capsulotomy, a procedure aimed to create a hole in the capsular bag to allow light to pass through again. However, this has many deleterious side effects and is also expensive for healthcare providers.
To reduce the complication of cataract surgery, artificial lenses have been extensively modified since they were first developed in 1952 by Harold Ridley. The new lens designs have helped reduce the impact of PCO progression, but prevention of PCO remains elusive. Lens manufacturing companies and research academics are continuously searching for new designs and materials to address PCO.

The overall aim of this proposal is to develop new lenses to restore high-quality vision following cataract surgery and prevent PCO formation. This research will unlock the potential of new lens design using emerging 3D printing technology as a new fabrication tool. This will have several advantages over the existing methods. The 3D printing method provides rapid prototype development of new lenses and takes weeks off the life cycle of lens development, expediting product development so lenses can reach patients quicker. There is also the potential to unlock new designs that would be impossible to produce by standard methods. These could potentially better the outcome of the surgery. This proposal also develops a drug delivery system to target the inflammation that occurs following surgery. The delivery system will enable controlled delivery of the drugs on-demand. Taken together, the new lens design, with local delivery of drugs, presents potential new therapies to treat cataract and prevent cataract complication.
This proposal will be led by Dr Aram Saeed who is an expert in drug delivery, polymer chemistry and development of medical devices, in collaboration with Prof Michael Wormstone, a world-leading expert in cataract and the PCO condition.

WHO WILL BENEFIT FROM THIS RESEARCH
Outside academia, this work will be particularly of interest to intraocular lens manufacturing and pharmaceutical companies. The long-term aim of this project is to develop new therapies that will have a direct impact on cataract patients, improving the surgical outcome. Faster and cheaper production of the lens will have an economic benefit through new business development, developing new skills, staff training, and generation new jobs as well as making significant savings to the healthcare system through better patient outcomes and reduced ongoing care.
HOW WILL THEY BENEFIT
The current prototyping process for Intraocular Lenses (IOLs) is often an expensive and time-consuming process. The steps set out in this proposal will provide a new prototyping platform that could expedite and refine the IOL development process. Furthermore, the complexity of manufacturing premium IOLs, for example, Zephyr IOL by Anew IOL technologies, (which can reduce PCO significantly but requires extensive machining time), could be significantly reduced or eliminated. This would allow more economical production of premium IOLs, and enhance availability toe cataract patients, delivering cost saving to healthcare systems alongside better patient outcomes.
EXPLOITATION AND APPLICATION
A market research report (literature search and follow-up interviews with identified IOL companies) was completed in July 2017 (supported by UEA impact funds). This generated a significant amount of interest from leading IOL companies including HOYA, Zeiss, Morcher, Anew IOL technologies, and most recently from Swiss Advanced IOLs. A preliminary patent application, focusing on the new 3D printable formulation to fabricate optically clear, foldable and biocompatible IOL, could be sought in liaison with the Research and Innovation Office at UEA. This could include potential claims on the new IOL design and a 3D printable formulation with appropriate optical properties. Our working relationship with the industrial partners and their general awareness of our reputation could significantly increase the likelihood that our work can be further exploited and be fed into their future development.
COMMUNICATION TO THE GENERAL PUBLIC
We envisage that the development of new therapies to treat cataract and prevention of secondary cataract will be of significant interest to general public globally, in particular to those in the developing countries. Therefore, updates on research will be shared and distributed nationally and internationally via public press releases. We also share the findings by creating patient bulletin in layman term, and through engagement with eye research charities (Fight for Sight). Other avenues, for example, YouTube and other social media platforms, will be used to disseminate the outcomes of this proposal.
EDUCATING SCIENTIFIC WORKFORCE
This project will train research staff in multidisciplinary skills essential for a future career. This could be either in the academic sector or industrial settings. Addressing future challenges requires innovative technologies and translational research. Training highly skilled and specialist staff will drive innovations forward. This proposal will train staff in the application of emerging 3D printing technology, polymer science, as well as biological and clinical subjects like cataract and PCO.