FDA Approves Dry-Eye Medication

"Drug regulators in the United States have approved Xiidra, which is lifitegrast ophthalmic solution 5 percent, to treat dry eye disease," reports Medical News Today. "Xiidra is the first prescription eye drop approved to treat both the signs and symptoms of dry eye - a group of conditions where the tear fluid produced by the eyes is either insufficient to lubricate the eyes properly, or of the wrong consistency." Read more.FDA, Food & Drug Administration, Xiidra, Dry Eye,

Get Your Scrips and Glasses Online--Without an OD

Opternative founders Aaron Dallek and Steven Lee, OD.

"The eyeglass prescription process is the latest health care service to be disrupted — and now optometrists are waging an all-out war against a startup that lets people do vision tests without looking away from their laptops," goes the Buzz Feed posting. "Less than a year ago, Opternative, a Chicago startup, began serving customers through its website. In that time, optometrist lobbying groups have successfully backed legislation that bans the company’s ability to operate in five states, including Georgia as of yesterday. Last month, the American Optometric Association complained to the Food and Drug Administration that the company’s service should be taken off the market and studied because it is allegedly operating without federal approval. In the same breath, the group likened startups like Opternative to the 'corporate equivalents of snake oil salesmen.'" Read more.

Vision Monday reported a few days ago: "Organized optometry won the latest round in its fight against online refraction when lawmakers in the state of Georgia enacted legislation last week which makes it illegal to issue a contact lens or spectacle prescription without an in-person, comprehensive eye exam conducted by a state-licensed practitioner." Read more.

FDA Updates Warning about Peroxide as a Contact Lens Cleaning Solution

Under new regulations, there will be a red warning label and red tip remind your patients that contact lens solutions with hydrogen peroxide require special handling. (This is a sample bottle. Actual products may have a different design, depending on the brand.)

FDA Approves Lucentis for Diabetic Retinopathy

The U.S. Food and Drug Administration (FDA) approved Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME), according to the drug's manufacturer Genentech. DME impacts nearly 750,000 Americans, about 10 percent of people with DR. The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials. For a few years, physicians have used the drug "off label" to treat DR. Read more.

FDA Gives Contact Lens Manufacturers a Year to Comply with UDI Rule

“Some medical device manufacturers will have an additional year to comply with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, a 2013 regulation intended to allow regulators to exercise greater oversight of the device industry,” reports RAPS.org. One group: Contact Lens manufacturers. “In an announcement this week, FDA indicated that at least one group of devices had been granted an extension. Class III contact lens and intraocular lens labelers, FDA said, would have until September 2015 to label their products in accordance with the UDI rule's direct marking requirements. The reason for the delay, FDA explained, was because of the likelihood of an ‘extremely large number of data submissions to the Global Unique Device Identification Database (GUDID)’—a number so large that FDA implied it might be a burden upon both the industry and its database.”  Read more.

New FDA Materials Warn about Dangers of Decorative Contact Lenses

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FDA brochure about the use of decorative contact lenses.

The FDA is launching a  campaign about the dangers of decorative contact lenses--more precisely the use of them without the fit of an OD or ophthalmologist. It's borrowing from the horror video genre that has inspired so many teenagers to slap on the color altering devices. The message also is backed by the American Optometric Association (AOA) and the Entertainment Industries Council (EIC). The three organizations produced and are distributing two public service videos designed to attract young people. The FDA has also released a brochure available at this link.

American Horror Story Helps Deliver Safety Message

The video, first screened at the recent AOA annual conference, uses clips from the television show American Horror Story, along with clips of professional makeup artists and optometrists. They note that before an actor or any individual can wear these lenses, he or she must have an eye exam, valid CL prescription, and lenses purchased from a reputable source.For more information about the program, click here.

Hollywood Joins FDA Decorative CL Campaign

The U.S. Food & Drug Administration (FDA), American Optometric Association (AOA) and the Entertainment Industries Council (EIC) have teamed up with entertainment industry-leading artists from the TV series American Horror Story on a first-of-its-kind decorative contact lens campaign to bring the dramatic realities of illegal and unsafe lens use to the forefront. “Artists and technicians work closely with each other, the actors, and doctors to ensure proper fit, vision and safety. We wouldn’t put our actors’ health in danger, and the viewers who want to emulate these characters shouldn’t either,” said technician Christien Tinsley, Tinsley Studios and Makeup Effects Designer for American Horror Story. The campaign launches just in time for end-of-school-year celebrations, a time when students are more likely to purchase and use decorative contact lenses. The premier of the first public service announcement in the series was held April 22nd at the 18th Annual PRISM Awards in Los Angeles. Read more.

FDA Red-Lists Sunglass Manufacturer

The FDA (U.S. Food & Drug Administration) "red-listed" Linhai Industrial Glasses (LIG) Factory, Duchuan 387 The Road , Linhai City, China, for its non-prescription sunglasses. That means Customs agents can detain without physically examining LIG eyewear with impact-resistant lenses.

The red-listing process began with a U.S. distributor. The firm heard reports about LIG's eyewear. It tested a shipment and found a breakage rate ranging from 40 to 70 percent. That's when the FDA became involved. The federal agency notes, "Due to apparent certificate irregularities SAN-DO collected a sample of children's sunglasses. The manufacturer's certificate indicated that no lenses broke during testing. However, WEAC testing of the sample found that nearly every lens broke completely. More recently, SAN-DO collected a sample of adult prescription lenses. WEAC testing of the sample found that 38% of the lenses broke completely." Eyeglasses and sunglasses imported into the U.S. must comply with 21 CFR 801.410: "Use of impact-resistant lenses in eyeglasses and sunglasses." A certificate of compliance, which testifies that the lens manufacturer has tested lenses for compliance, must accompany each shipment. In the past three years, the FDA has red-listed several manufacturers in China. Read more.

FDA Approves Phase III Study of Inlay for Presbyopia

ReVision Optics, Inc. (RVO), has received conditional approval from the U.S. Food and Drug Administration (FDA) to continue and complete enrollment in its Phase III clinical trial with its Raindrop™ Near Vision Inlay (formerly the PresbyLens). The prospective, multicenter Phase III clinical trial is evaluating the safety and effectiveness of the Raindrop Near Vision Inlay in improving near vision in subjects with presbyopia under an Investigational Device Exemption (IDE). Read more.

FDA Approves Argus II for RP

After more than 20 years of research and development, the Food and Drug Administration has approved the Argus II retinal prosthesis system for the treatment of alte stage retinitis pigmentosa. That's the word from Second Sight Medical Products, Inc., which spent more than two decades researching the product. The FDA's actions follow receipt of the European approval in 2011 and a unanimous recommendation by the FDA’s Ophthalmic Devices Advisory Panel in September 2012. The company says that the product provides electrical stimulation of the retina to induce visual perception individuals blinded by retinitis pigmentosa. Although the resulting vision is not the same as when these patients had normal vision, investigators involved in the clinical trial of the Argus II are eager about the approval. Read more.

Here's a more detailed article in the New York Times: "The Food and Drug Administration on Thursday approved the first treatment to give limited vision to people who are blind, involving a technology called the artificial retina. The device allows people with a certain type of blindness to detect crosswalks on the street, the presence of people or cars, and sometimes even large numbers or letters. The approval of the system marks a milestone in a new frontier in vision research, a field in which scientists are making strides with gene therapy, optogenetics, stem cells and other strategies. ...The artificial retina is a sheet of electrodes implanted in the eye. The patient is also given glasses with an attached camera and a portable video processor. This system, called Argus II, allows visual signals to bypass the damaged portion of the retina and be transmitted to the brain.” Read more.

Opthalmoscope Adapter Receives 501(k) Clearance

Welch Allyn has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its iExaminer—a hardware adapter and associated software that allows healthcare providers to capture, store, send and retrieve images from its PanOptic ophthalmoscope using the iPhone 4 or 4S, notes a company spokesperson. Available for shipment on February 11, the iExaminer rapidly captures and transmits the retinal images created by the PanOptic for easy, cost-effective eyeground image documentation.Read more.

Alerts about Illegal Eyewear, Sunglasses, and Contact Lenses

By updating Import Alert 86-07, the U.S. Food and Drug Administration (FDA) has renewed authority for federal officials to detain, without physical examination, substandard eyeglass and sunglass lenses manufactured in and shipped from foreign countries, primarily lenses produced in China. Under current law, eyeglasses and sunglasses imported into the United States must comply with strict impact resistance requirements. A certificate must accompany all imported eyeglasses and sunglasses showing that the lens manufacturer has conducted the required impact resistance tests. Read more.

Here's the beginning of the alert:

 Eyeglasses and sunglasses imported into the United States are required to comply with 21 CFR 801.410, "Use of impact-resistant lenses in eyeglasses and sunglasses". A certificate to comply with 21 CFR 801.410(g) must accompany each entry of eyeglasses and sunglasses showing the lens manufacturer has conducted tests of the lenses using the impact test described in paragraph (d)(2) of 21 CFR 801.410 or any equal or superior test. It has been reported that certificates from foreign manufacturers may not be valid. Tests by one U.S. distributor revealed 40-70% breakage which differed significantly from the manufacturer's certificate. Due to apparent certificate irregularities SAN-DO collected a sample of children's sunglasses. The manufacturer's certificate indicated that no lenses broke during testing. However, WEAC testing of the sample found that nearly every lens broke completely. To read more of the alert, click this link.

Meanwhile, "the Minneapolis office of Homeland Security Investigations is warning consumers about counterfeit products," according to the CBS News affiliate (WCCO) in Minneapolis. "Homeland Security agents showed WCCO a room full of fake products, made to look like the real thing. But on closer examination, it is clear that these items are of extremely poor quality — everything from contact lenses to prescription medication." Read more.

FDA Warns 5 ECPs about Their Lasik Promotions

Law 360 reports that “the U.S. Food and Drug Administration said Tuesday it had warned five eye care providers to stop their allegedly misleading promotion of refractive lasers used in Lasik surgeries, saying the companies failed to provide adequate warnings about risks and could face penalties if they don't shape up.” Read more.

FDA Approves Besivance to Treat Conjunctivitis

The U.S. Food and Drug Administration (FDA) has granted additional labeling indications for Bausch + Lomb's Besivance (besifloxacin ophthalmic suspension) 0.6 percent eyedrop. It is now indicated to treat bacterial conjunctivitis infections caused by susceptible isolates of Pseudomonas aeruginosa.

FDA Considering Presbyopic Implantable Lens

Presbia, a medical device producer of near-vision restoration, reportedly has received a letter from the U.S. Food & Drug Administration (FDA) indicating that it is being actively considered for an Investigational Device Exemption (IDE, G120225) for its Presbia Flexivue Microlens, an implantable corneal inlay solution for presbyopia, the age-related loss of near vision.Read more.

FDA Warns of Potential Eye Infections from NECC Compound

"Health officials are warning that more people may be at risk from contaminated drugs made by a Massachusetts company linked to a growing meningitis outbreak," reports the New York Times. "The Food and Drug Administration reported on Monday that the company’s products may have also caused other types of infections in patients who have had eye operations or open-heart surgery." Read more.

Food and Drug Administration Statement

[10-15-2012] As a result of FDA, CDC, and state health departments’ ongoing investigation of contamination at the New England Compounding Center’s (NECC) Framingham, Massachusetts facility, on October 4, the FDA advised providers to not use any NECC products. On October 6, NECC announced a recall of all its products. A complete list of all products subject to this recall can be accessed here [HTML | PDF]. The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use.   (Statements relating to eye health issues appear underlined and in italics.)

Also as a result of the ongoing investigation of NECC, a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA. Triamcinolone acetonide is a type of steroid injectable product made by NECC. The cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product.

In addition, two transplant patients with Aspergillus fumigatus infection who were administered NECC cardioplegic solution during surgery have been reported. Investigation of these patients is ongoing; and there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.

FDA continues to evaluate these reports, and when the agency obtains additional information, it will be promptly relayed to the public. FDA has not confirmed that these three infections were, in fact, caused by an NECC product

At this point in FDA’s investigation, the sterility of any injectable drugs, including ophthalmic drugs that are injectable or used in conjunction with eye surgery, and cardioplegic solutions produced by NECC are of significant concern, and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection. At this time, no cases of infection have been reported in connection with any NECC-produced ophthalmic drug that is injectable or used in conjunction with eye surgery, but FDA believes this class of products could present potentially similar risks of infection. Products from NECC can be identified by markings that indicate New England Compounding Center by name or by its acronym (NECC), and/or the company logo that can be accessed here.

FDA Advice to Healthcare Practitioners

The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use. Based on the new information described above, out of an abundance of caution, FDA advises you to follow-up with patients for whom you administered an injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012. FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories.

You should inform patients who received the NECC products noted above of the symptoms of possible infection and instruct them to contact you or another healthcare provider immediately if they experience any of these symptoms.

The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status. Symptoms for other possible infections may include fever; swelling, increasing pain, redness, warmth at injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest).

The FDA recognizes that some health care professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of today's announcement. We ask you to use your clinical judgment in deciding which patients are at risk and contact those patients in whatever communications mode you prefer, whether it is email, phone or letter. Face-to-face communication with patients is not necessary.

Clinicians are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch.

Health care professionals may dial FDA’s Drug Information Line at 855-543-DRUG (3784) and press * to get the most recent information regarding the meningitis recall and speak directly to a pharmacist.

Lucentis Approved to Treat Diabetic Macular Edema

"The U.S. Food and Drug Administration...gave its approval to the drug Lucentis as a treatment for diabetic macular edema (DME), making it the first medicine approved for the ailment," reports U.S. News and World Report. "According to the U.S. Centers for Disease Control and Prevention, DME occurs when fluid enters the macula, the central part of the eye's retina. This causes the macula to expand, blurring vision. Because up to 26 million Americans have either type 1 or type 2 diabetes, this eye condition is a major source of new-onset vision loss, the FDA said. In 2010, 3.9 million diabetic adults had trouble with their vision. Laser surgery has been the only approved treatment until now for DME." Read more.

Report Adverse Effects of Decorative CLs to FDA

With a growing number of websites and small retailers continuing to illegally offer decorative, non-corrective contact lenses for sale without prescription, optometrists should be diligent in reporting all adverse events associated with such lenses to the U.S. Food & Drug Administration’s (FDA) MedWatch Safety Information and Adverse Event Reporting Program, according to the AOA Advocacy Group. Information may be reported to the FDA’s MedWatch program by phone at 800-FDA-1088, by fax at 800-FDA-0178, online at www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. Read more.

FDA Committee Approves Use of Lucentis for DME

Genentech says the U.S. Food & Drug Administration (FDA) Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously to recommend approval of the 0.3 mg dose of Lucentis (ranibizumab injection) for treatment of diabetic macular edema (DME). The majority of DODAC (8-2) also recommended the 0.5 mg dose. The FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for Lucentis in DME by August 10, 2012. The FDA generally follows advisory committee recommendations, although it is not bound to do so. Read more.

FDA Tweats Warning about Cosmetic CLs to Twilight Fans

"The FDA issued a message via Twitter to fans of the young adult Twilight series attending the official convention in San Antonio in August, cautioning them against non-regulated custom contact lenses that let them imitate their 'fave vampire,'"according to Mass Device. "'Want 2 look like your fave vampire?' the federal watchdog agency tweeted. 'C an eye doctor before buying costume/fashion lenses.' The tweet included a link to an FDA one-pager on the dangers of decorative contact lenses, which can cause allergic reactions, cuts or scratches on the cornea, eye infections, decreased vision or even blindness." Read more.