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Report by Dr Andreas Hartwig
Representatives from Optegra Eye Sciences attended a ‘Developing Novel Endpoints for Premium Intraocular Lenses (IOLs) Workshop’ that was organised by the American Academy of Ophthalmology and the American Food and Drug Administration (FDA). This ‘game changing’ meeting was held at the FDA headquarters in Silver Spring, Maryland, USA on March 27th 2014.
The purpose of the workshop was for key stakeholders to focus on methodologies used in evaluating IOL safety and efficacy and to explore how to get innovative and safe products to patients in a timely fashion. It is of note that many advanced technology IOLs widely used in Europe, are not currently available in the USA.
An authoritative panel of clinical, regulatory and industry experts gave an overview of the relevant topics in a busy morning session and then specific aspects were discussed in small breakout sessions in the afternoon.