The Translational Vision Summit’s expressed aim was to advance innovation in the diagnosis and treatment of eye disease. In an ARVO-Asia first, it brought together selected researchers and their current projects with senior staff from regulatory authorities – including the US FDA and Australia’s TGA – senior corporate managers from major multinationals, investors, and other stakeholders.By gathering those doing the ‘inventing’ together with those who might champion, and eventually market, a successful product, it was hoped the summit would expedite a bench-to-bedside translation of the work being undertaken around the world.Disciplines represented among the innovations included: anterior and posterior segments, glaucoma, and st cell and gene therapy.{{quote-A:R-W:450-I:2-Q: The aim of most regulatory authorities was to oversee a decrease in the product development lifecycle coupled with more mutual recognition of other regulatory agency approvals, all while maintaining patient safety at the highest level. -WHO:Dr Malvina Eydelman, Biomedical Engineer and Ophthalmologist}}Dr Malvina Eydelman, the FDA’s Director of Devices (ophthalmic, ear, nose, and throat) delivered the opening rarks. Eydelman, a biomedical engineer and ophthalmologist, explained the aim of most regulatory authorities was to oversee a decrease in the product development lifecycle coupled with more mutual recognition of other regulatory agency approvals, all while maintaining patient safety at the highest level.She acknowledged that a truly great idea per se was not a passport to success as many other factors, together, were required before a product entered production.The anterior segment section featured many interesting contributions. Professor Thomas Millar and the team at Western Sydney University presented a passive IR-thermography imaging syst of the anterior eye with special reference to the tear film, while post-doctoral researcher Dr Atikah Haneef from the University of Liverpool (UK) detailed a unique chical cross-linking agent for use in the cornea (especially for keratoconus).Another highlight came from University of Sydney graduate studentMs Daisy Shu, who detailed the effects of TGFβ on crystalline lens epithelial cells.Professor Jonathan Crowston, managing director of CERA, introduced the glaucoma section. The renowned glaucoma expert revealed imaging technology and relevant software was improving monitoring of the condition and, as a result of genome-wide association studies (GWASs), five new susceptible genetic loci had been identified. He also itised four unmet needs in the glaucoma discipline.
- A need to differentiate between open-angle glaucoma,pigment dispersion syndrome, and pseudoexfoliative glaucoma more definitively
- Improved patient compliance with regard to treatment. Up to 50% of glaucoma cases are non-compliant six months later, just 37% of glaucoma prescriptions are being filled three years after diagnosis, and as few as 10% of cases are compliant fully
- Therapies that seek to protect retinal ganglion cells (RGCs) (neuroprotection) have failed to materialise. In-vivo imaging and multifocal ERG and other electrophysiology techniques can now monitor RGC condition and function adequately, suggesting that success with a neuroprotective agent can be confirmed if and when it happens
- Efficacious antifibrotic agents for use in glaucoma surgery. Some trialled have proved to be toxic intraocularly.
Another highlight was a presentation by UC San Francisco’s Dr Shan Lin of a precision, piezo-electric dispenser of eyedrops. The device incorporates an LED fixation target, which focuses on limiting both over and under dosing of ocular therapeutic agents by the ordinary user. Most users would probably welcome the routine availability of such a device, provided it was an affordable option.{{quote-A:L-W:450-I:3-Q: Imaging technology and relevant software was improving monitoring of the condition and, as a result of genome-wide association studies (GWASs), five new susceptible genetic loci had been identified. -WHO:Jonathan Crowston, Managing Director of CERA}}Seeking an answer to everyone’s least favourite clinical test – visual fields assessment – Professor Algys Vingrys and the team from the Department of Optometry, UniMelb have created a perimeter app (Melbourne Rapid Field App) for the iPad that facilitates self-assessment (an Android version is not possible currently because of fundamental differences in the operating syst).A gaming paradigm is used where possible and in trials comparing its output with that of a Humphrey Field Analyser, a correlation of 0.9 was achieved. Given the difference in instrumentation costs and a shift of responsibility to suitable adults, the attraction of the approach is obvious.Professor Mark Gillies of Sydney’s Save Sight Institute (SSI) introduced the posterior segment. While discussing the outcomes of anti-VEGF therapy for AMD, he noted that Australian results were superior to similar studies in the US because of adequate dosing here and under-treatment there.Another key factor is the high cost-to-patient – both with and without subsidies – for the expensive treatments. Those results suggest that, despite the obvious attraction, PRN dosing may not be ideal as Gillies thought it unlikely that companies would reduce the costs of anti-VEGF therapy in the foreseeable future.The day ended with regulatory agency representatives offering advice on what is required to get approval for drugs or devices, the extensive online resources offered (especially by the US FDA), and what procedures need to be followed to avoid application pitfalls.Meanwhile, a panel of senior company representatives gave their perspective on what they seek and how they should be approached. They also discussed the likely options they might investigate when offered a new product.This often depended on the state of development reached, the clinical trials conducted, etc. at the time of the offer.While no one claimed that the day was perfect in its form or execution, all agreed enthusiastically that the concept was worthwhile, and with some tweaking, could become a regular feature of ARVO meetings.{{image4-a:c-w:1050}}
