The birth of a new technology – 510k approved for first ever EDOF contact lenses for presbyopia

Brien Holden Vision Pty Ltd. (BHV) today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Extended Depth of Focus (EDOF) contact lenses, a world first for the correction of presbyopia – people in need of vision at distance, for computers and close up.

Professor Brien Holden, BHV Board member and CEO of the Brien Holden Vision Institute (BHVI), at the University of New South Wales, whose scientist, Dr. Ravi Bakaraju, invented the technology, has hailed this as ‘the birth of a new technology’.

“This is a landmark for the Brien Holden Vision Institute, the creation of a new technology that provides clear vision from distance to near while minimising ghosting or double imaging. This is a vital step forward in quality vision for presbyopes”, said Professor Holden. “The contact lenses, available at the end of 2015, represent a significant growth opportunity for our robust science, technology, research and development, licensing, education, public health and blindness prevention activities as BHV will donate a substantial part of its profits to fund our work at a time when both science and humanitarian development funds are drying up.”

Presbyopia affects over 1 billion people and is expected to increase to 3 billion by 2050. “Although a range of treatments are available, the number of presbyopes is rising – the BHV EDOF contact lenses will play a major part in helping those with presbyopia see more clearly”, said Professor Holden. “Other EDOF lenses are also being tested for their ability to control the rate of progress of myopia in children at risk, an extremely important current concern in eye care.”

BHV’s new generation of EDOF contact lenses uses higher order aberrations to optimise retinal image quality over a wide range of distances from far to near while minimising ghosting and haloes. Invented by one the Institute’s top scientists, Dr Ravi Bakaraju, the EDOF contact lenses perform relatively independent of a patient’s natural aberrations and variation in pupil size and are designed to meet the vision needs of emerging presbyopes, middle aged and older people.

“Many claims are made that multifocal lenses provide simultaneous vision at various visual distances but often this comes at the cost of reduced contrast, increased ghosting and compromised overall vision satisfaction,” said Dr Bakaraju. “These shortcomings are often exacerbated with low illumination levels. Such visual compromises have been associated with an increase in patient dropout rate and lack of confidence in fitting by practitioners. Our comprehensive data tells us that our contact lenses will greatly benefit the U.S. market as well as others.”

In 2013, the Institute announced the spin-off of Brien Holden Vision, a commercial subsidiary that provides a pathway for advanced and beneficial products and services for those in need of vision correction. “We have a rich history of innovation”, said Professor Holden. “Products we have co-developed include silicone hydrogel lenses, the most popular soft contact lenses used in the world today, the leading soft toric lenses for astigmatism and the leading multifocal contact lens in the U.S. These products have generated over $30 billion in sales for the industry over the last 15 years, and earned Australia and the partners in the Vision CRC $300 million in royalties while bringing in $1.5 billion in cash and in-kind research funds.” “This will be the first Brien Holden Vision product brought to the market by our own spin-off company – exciting times.”

“We have a vision, to be an established contact lens company, bringing innovative and quality contact lens products to market,” said Dr Paul Erickson, CEO, Brien Holden Vision Pty Ltd. “This achievement is testimony to the ongoing dedication and professionalism of our team in Sydney, Australia, as well as our collaborators worldwide, who have worked hard to bring this new technology to life.

“Dr Ravi Bakaraju, and his Vision Innovations Science and Technology Applications (VISTA) team, working with the Institute’s Technology Group led by Professor Arthur Ho and Dr. Klaus Ehrmann, have jointly developed a product that we believe will achieve great things.”

Dr Kah Ooi Tan who is CEO of BHV Innovation Pte Ltd., the Singapore based BHV company, and responsible for the worldwide marketing of EDOF products, especially in Asia, said, “Practitioners having long needed a lens for presbyopes that provides excellent distance, intermediate and near vision with minimal ghosting, so we are excited about product being cleared by the FDA. Early indications are that the EDOF lenses designed for myopia control are effective in reducing the rate of progress of myopia, and because of the Extended Depth of Focus technology, they provide excellent vision.”

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