Alcon receives European approval for new trifocal presbyopia-correcting intraocular lens for patients undergoing cataract surgery
Jun 16, 2015
Innovative AcrySof® IQ PanOptix® trifocal intraocular lens design to improve near to intermediate vision and increase independence from glasses
More than three million cataract surgeries performed in Europe annually1
Basel, Switzerland, June 16, 2015 – Alcon, the global leader in eye care and a division of Novartis, has received European CE Mark for its AcrySof® IQ PanOptix® trifocal intraocular lens (IOL) for patients undergoing cataract surgery who elect to address their near, intermediate, and distance vision needs with a single lens. The AcrySof IQ PanOptix trifocal IOL is an important addition to Alcon’s broad portfolio of intraocular lenses for cataract patients.
"The AcrySof IQ PanOptix trifocal IOL is a significant innovation which further augments Alcon’s presbyopia correcting portfolio, leveraging Alcon’s market-leading AcrySof IQ IOL platform," said Franck Leveiller, Head of Research and Development for Alcon’s Surgical Franchise. "It is designed to provide exceptional functional vision from near to intermediate, in addition to providing excellent distance vision."
More than three million cataract surgeries are performed each year in Europe1. Without presbyopia-correcting IOLs, most patients undergoing cataract surgery experience compromised near vision often requiring additional vision correction following surgery such as reading glasses or contact lenses. The AcrySof IQ PanOptix trifocal IOL is indicated for adult patients with and without presbyopia undergoing cataract surgery who desire near, intermediate and distance vision with increased spectacle independence.
"Today’s patients undergoing cataract surgery are more likely to seek vision correction options to address various lifestyle tasks such as reading books, using electronic tablets, working on computers and performing outdoor activities without the need for glasses or contact lenses," said Richard Packard, MD, FRCS, FRCOphth, Director and senior ophthalmologist, Arnott Eye Associates, London, United Kingdom. "The AcrySof IQ PanOptix trifocal IOL is an important option that should provide these patients with a full range of vision and thus significantly reduced dependence on glasses."
A cataract is a clouding of the natural lens of the eye that affects vision. As a cataract develops, the eye’s lens gradually becomes harder and cloudy which scatters light rays and allows less light to pass through it, thus reducing the patient’s ability to see. The vast majority of cataracts occur as part of normal aging but radiation exposure, taking steroids, diabetes, and eye trauma can accelerate the development of cataracts. Additionally, cataracts can be hereditary and congenital and can present shortly after birth2. Cataracts are the most common age-related eye condition and the leading cause of preventable blindness in adults 55 and older3. Cataracts are treated by surgically removing the eye’s cloudy natural lens and replacing it with an intraocular lens (IOL). More than 98 percent of cataract surgeries are considered successful and patients can usually return to their normal routines very soon after surgery4.
Presbyopia is an eye condition that occurs as part of natural aging. The lens of the eye loses the ability to change shape to focus on close objects, such as smart phones, computers, books and menus5. The first signs of presbyopia are eyestrain, difficulty seeing up close in dim light and problems focusing on small objects and/or fine print. Once a person is in their 40s, it is likely they will experience presbyopia and will require vision correction such as reading glasses or multifocal contact lenses6.
Important Information about AcrySof PanOptix IOLs
As with any surgical procedure, there are associated risks. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens of this type. This is particularly so in a patient with any of the conditions described in the AcrySof IQ PanOptix physician labeling. Some patients may experience visual disturbances and/or difficulty seeing due to the multifocal lens design, especially under dim light conditions. As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explantation of an AcrySof IQ PanOptix IOL. Posterior capsule opacification (PCO) may significantly affect the vision of patients with multifocal IOLs sooner in its progression than in patients with monofocal IOLs.
The foregoing release contains forward-looking statements that can be identified by words such as "should," "expected," "will," or similar terms, or by express or implied discussions regarding potential additional marketing approvals for the AcrySof IQ PanOptix Intraocular Lens, or regarding potential future revenues from the AcrySof IQ PanOptix Intraocular Lens. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the AcrySof IQ PanOptix Intraocular Lens will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that the AcrySof IQ PanOptix Intraocular Lens will be commercially successful in the future. In particular, management’s expectations regarding the AcrySof IQ PanOptix Intraocular Lens could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the company’s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.