Iluvien is designed to deliver sustained, low doses of flucocinolone acetonide to the retina at the rear of the eyeball in patients with diabetic macular edema.
Eye doctors often omit risks and exaggerate benefits of Lasik vision-correction surgery and it could lead to federal enforcement, according to an FDA warning to eye care professionals.
The watchdog agency warned eye doctors to be up-front and honest when promoting vision-correcting Lasik eye surgery, and not to downplay the limitations and dangers of the laser surgery procedure.
Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Dear Eye Care Professional:
On May 22, 2009, the Food and Drug Administration (FDA) issued a letter to eye care professionals regarding the promotion and advertising of FDA-approved lasers used during refractive procedures, including laser-assisted in-situ keratomileusis (LASIK). This letter followed an April 2008, FDA Ophthalmic Devices Panel public meeting, at which the agency received information that eye care professionals’ advertising and promotion often failed to properly inform consumers of the indications, limitations, and risks of refractive procedures and the lasers used for those procedures.
Novartis AG’s (NYSE:NVS) Alcon subsidiary lost its bid to throw out a lawsuit filed by a Florida ophthalmologist accusing it of infringing a patent for intraocular lens technology.
Dr. James Nielsen sued Alcon in December 2008, alleging that the Swiss medical device giant violated his patent for a “Multifocal Intraocular Lens.” Alcon moved to have Judge Janet Boyle of the U.S. District Court for Northern Texas toss a magistrate judge’s recommendation that she deny its motion to have the case dismissed.
Optos plc (LON:OPTS) agreed to pay $17.5 million plus royalties for Opko Health Inc.’s (NYSE:OPK) ophthalmic instruments operation.
Miami-based Opko Health said the deal is for its “worldwide activities for the development and commercialization of ophthalmic diagnostic imaging systems,” according to a press release. The plan is to integrate Opko’s OCT SLO device into Optos’ widefield technology, according to the release.
Shares of Optos plc (LSE:OPTS) gained 6.4 percent after the company announced that the FDA granted 510(k) clearance in the U.S. for its Project Daytona retinal scanning device.
The British ophthalmology device maker’s stock closed at £1.62 today (about $2.64), up about 15 cents since August 25, the day before the clearance announcement, when OPTS shares closed at £1.52 ($2.49) on the London Stock Exchange.
Avedro Inc. expanded its commercial reach in Japan with a "significant investment" from Shinagawa, a Lasik eye surgery center in Tokyo that has performed more of Avedro’s vision-enhancing procedures than any other.
Shinagawa, which has been performing corneal surgeries with Avedro’s Lasik KXL system for the past six months, is expanding the service to centers in Nagaya, Osako, Sapporo and Fukuoka.
The KXL system is used in Avedro’s Lasik Xtra procedure, an accelerated cross-linking surgery that helps restore corneal strength after a Lasik procedure.
Medtronic Inc. (NYSE:MDT) has signed on as an investor in a $24 million financing round for PowerVision Inc.
The Belmont, Calif.-based PowerVision develops intraocular lenses with a novel technology that uses fluid inside the lens that allows natural forces in the eye to change the lens’ shape and provide better focusing ability.
Avedro Inc. landed $25 million in a series C financing round, company officials announced yesterday.
The Waltham, Mass.-based company will use the funds to expand its commercial operations overseas.
Avedro, a private company, also plans to pursue U.S. Food and Drug Administration clearance for its Vedera cornea flattening treatment, designed to treat near-sightedness, and its KXL corneal cross-linking system.
The KXL system won CE Mark approval in the European Union in November 2010.
As a glasses wearer for over 40 years, I’ve been an active user of many lens “technologies” Now that I’m nearly 50, I wear progressive lenses which ease my eye strain during screen time and close up work.
However, there is an issue – when I look down, I lose my distance vision. My prescription is -7 diopters so I cannot easily switch between two pairs of glasses, one for distance and one for closeup. An ideal bifocal would enable me to change the my glasses prescription in real time.
That’s now possible with the PixelOptics electronic lens built with liquid crystal technology.
New data on patients implanted with a microchip designed to restore eyesight indicates that the device improved their vision enough to have an impact on their daily lives.
Retina Implant AG, the maker of a subrential implant designed to restore vision in people suffering from retinitus pigmentosa, said initial findings from the company’s second clinical trial showed that the first seven patients permanently implanted with the company’s device experienced restored useful visual function that enabled them to improve activities of daily living.