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FDA

Eye Implant Smaller Than a Grain of Sand Could Revolutionize the Treatment of Glaucoma

The US Food and Drug Administration (FDA) has approved Allergan’s drug-releasing implant, Durysta, for administration within the cavities of the eye to reduce intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Measuring just 0.2mm by 1mm, the tiny polyester plug gradually releases bimatoprost, a drug already found in eye drops often prescribed to treat the condition. However, more than seven in ten patients fail to use their drops properly — reducing the drug’s benefit — while others struggle with side-effects. read more

Mojo Vision Develops Augmented Reality Screen on a Contact Lens

Mojo Vision is revealing a smart contact lens with a tiny built-in display that lets you view augmented reality images on a screen.

Steve Sinclair, senior vice president of marketing at Mojo Vision, calls it Invisible Computing, a platform that overlays information on what you see in the real world — without requiring you to wear a huge gadget on your head.

“We have figured out how to take that world’s most dense display,” Sinclair said. “We have a medical-grade contact lens, supply power, and data. And eventually we will get to the point where we’ve got all sorts of cool gadgets to show.” read more

First FDA Approved Contact Lens to Slow Childhood Nearsightedness Coming in March

The FDA has approved its first contact lens designed to effectively slow the progression of nearsightedness in children, starting in ages 8 to 12.

CooperVision’s MiSight lens is a soft, single-use and disposable contact, made to be discarded at the end of each day.

A three-year clinical study showed the lens was able to slow the elongation of the eyeball from front to back by an average of 52% across annual check-ups—one of the main causes of myopia, as incoming images begin to come into focus at a point in front of the retina, instead of precisely on it. read more

doctors Are Now Performing Eye Surgery with Newly FDA Approved Lens

A Las Vegas doctor is changing the way patients view their world — he’s doing it through a new surgery with lenses just approved by the FDA.

“As long as I can remember, I could never read the blackboard until I got glasses,” Judy Reiber said. “I had bad vision my whole life.”

Reiber is now in her 70s. She had glasses since she was 12.

“I went through contacts when they first came out,” she said.

Reiber’s vision was around 20/80, and she said it was getting worse every year.

“It’s horrible,” she said. “My husband has said that the worst thing in the world is me saying, ‘I can’t find my glasses,’ and I bet I say that seven times a day.” read more

FDA Approves Hydrus Microstent for Glaucoma Surgery

The US Food and Drug Administration (FDA) has approved the Hydrus Microstent, a device used for microinvasive glaucoma surgery (MIGS) in patients with mild to moderate primary open-angle glaucoma, in conjunction with cataract surgery.

“We are pleased by the FDA’s approval of our Hydrus Microstent,” Dave Van Meter, President and CEO of Ivantis said in a statement. “Although the device has been used in over 4,000 procedures internationally, many of which are now well past five years, the Hydrus Microstent represents a novel device platform to FDA, and this approval occurred within our projected timeline.” read more

Glaukos Gets FDA Approval for Glaucoma Treatment

Glaukos has just received FDA approval for its iStent inject Trabecular Micro-Bypass System indicated for the reduction of intraocular pressure in primary open-angle glaucoma patients undergoing concomitant cataract surgery.

The FDA approval is based on pivotal trial data showing the iStent inject achieved a statistically significant reduction in unmedicated diurnal IOP in patients undergoing cataract surgery at 24 months.

The Glaukos iStent device is just 1 millimeter in length. It is one of the smallest medical device known to be implanted into humans. read more

Artificial Iris Implant Gets Approval from FDA

The Food and Drug Administration has approved the first artificial iris implant in the United States called the CustomFlex Artificial Iris. The implant will benefit patients with missing or damaged irises due to aniridia, traumatic injury, albinism, and melanoma.

The CustomFlex Artificial Iris is produced by the German firm HumanOptics AG. The CustomFlex Artificial Iris will treat adults and children with a missing or damaged iris. It is a permanent implant designed to replace the colored contact lenses currently used by patients with the problem. read more

New Stem cell Therapy is Now FDA Compliant in the United States

Dr. Jeffrey N. Weiss, a physician, retinal specialist and electrical engineer did his first ocular retinal stem cell surgery in Germany and now it is FDA compliant in the United States.

“I will not accept that somebody is blind, and that’s it,” he said. “In 2010, I did the first ocular retinal stem cell surgery in Düsseldorf, Germany.”

Since then, Dr. Weiss says his procedure is now FDA compliant in the United States. Dr. Weiss uses stem cells from the patient’s own bone marrow.

“These are your stem cells,” he said. “You do not need to be immunosuppressed.” read more

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