FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD patients

The U.S. Food and Drug Administration  announced July 6 it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD).

Surgically implanted in one eye, the IMT is a small telescope that replaces the natural lens and provides an image that has been magnified more than two times.

AMD, a condition that mainly affects older people, damages the center of the retina (macula) and results in a loss of vision in the center of the visual field. About 8 million people in the United States have AMD and nearly 2 million of them already have significant vision loss, according to the National Eye Institute. AMD can make it difficult or impossible to recognize faces or perform daily tasks such as reading or watching television.

"This innovation has the potential to provide many people with an improved quality of life," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The IMT is available in two models: one that provides 2.2 times magnification and another 2.7 times magnification. The IMT is designed to magnify and project images onto a healthy portion of the retina. The IMT is intended to be implanted in only one eye; the non-implanted eye is used for peripheral vision.

The IMT is used in patients ages 75 years and older with stable severe to profound vision impairment (when vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) associated with end-stage AMD. These patients also have evidence of a visually significant cataract.

Patients agree to undergo training with an external telescope with a low vision specialist prior to implantation to determine whether adequate improvement in vision with the external telescope can be obtained and to verify if the patient has adequate peripheral vision in the eye that would not be implanted. Patients also agree to participate in a post-operative visual training program.

In a 219-patient, multi-center clinical study of the IMT, 90 percent of patients achieved at least a 2-line gain in either their distance or best-corrected visual acuity, and 75 percent of patients improved their level of vision from severe or profound impairment to moderate impairment.

Because the IMT is a large device, implantation can lead to extensive loss of corneal endothelial cells (ECD), the layer of cells essential for maintaining the clarity of the cornea, and chronic endothelial cell loss. The chronic rate of endothelial cell loss is about 5 percent per year. Significant losses in ECD may lead to corneal edema, corneal decompensation, and the need for corneal transplant. In the study, 10 eyes had unresolved corneal edema, with five resulting in corneal transplants. The calculated five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively.

To ensure that the risks of IMT implantation are sufficiently and consistently communicated to patients, the FDA and the manufacturer created detailed labeling, including an Acceptance of Risk and Informed Decision Agreement, which patients must complete prior to IMT implantation. The agreement provides a guide for patients and their physicians to discuss the risks associated with IMT implantation. Patients should be given adequate time to review all of the information regarding the IMT.

As a condition of FDA approval, the manufacturer, VisionCare Ophthalmic Technologies Inc. of Saratoga, Calif., must conduct two post-approval studies. In one study, VisionCare must continue follow-up on the subjects from its long-term follow-up cohort for an additional two years. Another study of 770 newly enrolled subjects will include an evaluation of the endothelial cell density and related adverse events for five years after implantation.

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Emory Eye Center Doctor Provides Retina Expertise at Emory Clark-Holder Clinic

Emory Eye Center physician Jiong Yan, MD, assistant professor of ophthalmology at Emory School of Medicine and retina specialist within Emory Eye Center, now sees patients at Emory Clark-Holder Clinic in LaGrange, Ga., in addition to her roles at Emory Eye Center and the Veterans Administration Medical Center. Yan will see patients in LaGrange every other Thursday of the month.

Yan’s expertise will enable the residents of Troup County to have access to an Emory Eye Center ophthalmologist who can provide the highest level of care for retinal disorders. Emory Eye Center is a top-ranked academic eye institution with a three-fold mission of quality patient care, innovative research, and ongoing education, training future ophthalmologists from around the world.

Yan’s interests include diabetic retinopathy, macular disease, retinal detachment and age-related macular degeneration. Additionally, she directs the inherited retinal disease unit at Emory Eye Center. In her position at Emory, she has been involved in eight clinical trials, serving as either principal investigator or co-investigator. She has published nearly 20 papers.

“We are pleased to be able to serve patients in the LaGrange community,” says Yan. “Our retina patients must often have a family member drive them to their clinic appointment. The Emory Clark-Holder Clinic location will help those in the immediate area have closer access to advanced ophthalmic care. Because many our of retina patients need treatments every two months, a more convenient clinic will allow them to make their appointments with more ease. We are excited to work with these patients and provide the care they need, near their homes.”

Timothy W. Olsen, director of the Emory Eye Center, says “Emory Eye Center is excited to have an opportunity to work with our neighbors to bring subspecialty care to West Georgia. I’m certain that the talent and compassion of Dr. Yan will benefit her patients as well as the community. We look forward to our ongoing collaborations at Emory Clark-Holder Clinic.”

Anna Kao, MD, an ophthalmologist serving at Emory Clark-Holder says, “Ophthalmology has been a long-standing tradition with Clark-Holder Clinic. It is very exciting to see the expansion of our service with Dr. Yan’s experience. With the advancement of new technology and medicine, we are able to make a significant difference in saving sight for retinal disorders such as age-related macular degeneration. Dr. Yan’s presence in LaGrange will allow our local and surrounding residents to be part of modern medical advances.”

Yan attended medical school at Louisiana State University (1998). She completed an internship at UMDNJ-Robert Wood Johnson Hospital in New Brunswick, N.J. (1999). She finished a residency in ophthalmology at Emory University (2002), a vitreo-retina fellowship at the Jules Stein Eye Institute, University of California (2004), and an honorary fellowship in retinal dystrophy and degeneration at Moorfields Hospital, London. She joined Emory Eye Center in fall 2004. Yan also serves as chief of the Retina Service in the department of ophthalmology at the Veterans Administration Medical Center, Atlanta.

Yan is board-certified in ophthalmology and is a fellow with the American Board of Ophthalmology. Memberships include the American Academy of Ophthalmology, the Association for Research in Vision and Ophthalmology, the American Society of Cataract and Refractive Surgery, and the Georgia Society of Ophthalmology.

Background
Emory Eye Center has a mission to conduct pioneering research into blinding eye diseases, to educate and train eye professionals, and to provide excellent patient care. The Department includes 35 ophthalmologists, eight optometrists, ten basic scientists, 11 post-doctoral fellows, and nine researchers in other Emory departments who hold joint appointments in the Emory University School of medicine’s Department of Ophthalmology. Ophthalmology research is supported by current NIH funding - $20 million through 2010. The Department remains in the top rankings (#9 – 2009) by U.S. News & World Report for the 13 years the magazine has held a ranking for Ophthalmology. It also ranks in the Top Ten in all four categories surveyed by Ophthalmology Times annual report. http://eyecenter.emory.edu

Established in 1936, Clark-Holder Clinic is the largest multi-specialty group practice in West Georgia employing more than 30 doctors and other healthcare providers with a staff of 170. Key facilities are located in LaGrange, West Point and Newnan. Clark-Holder Clinic has provided medical services to the citizens of west Georgia and east Alabama for nearly 70 years. The partnership with Emory Healthcare physicians in January 2008 provided access to the highest level of care for the residents of Troup County and the surrounding areas.
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FDA Announces Class I Recall of Ophthalmic Surgical Device

The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.

OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). At that time, AMO informed customers of the number and nature of adverse event reports associated with OVD from that lot, and included a fax reply form for quick communication.

However, as of December 3, 2008, AMO had retrieved only 964 units of the 1,450 that had been distributed in the United States.

AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.

TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens). TASS has been linked to solutions and devices used during eye surgery, such as OVDs, intraocular lenses and irrigation solutions.

The FDA urges anyone in possession of any units from the recalled lot, whether units were purchased from the company or provided as a sample by a sales representative, to remove them from inventory, and contact AMO at 1-877-AMO-4Life to make arrangements for return. The lot number of the device is displayed on the side panel of each unit.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to AMO by calling 1-877-AMO-4LIFE and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD, 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088

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FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain

The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.

Companies must stop manufacturing unapproved BSS products on or before Nov. 24, 2008, and must stop shipping such unapproved products on or before Jan. 21, 2009. After these dates, all unapproved BSS products must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved BSS products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the company.

Today's action does not affect approved ophthalmic BSS products.

Companies marketing any unapproved topical drug products containing papain must stop manufacturing them on or before November 24, 2008. Companies or others engaged in shipping these products must stop shipping these products on or before Jan. 21, 2009. After these dates, all topical products containing papain must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved topical papain products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the company.

No topical drug product containing papain has been approved by the FDA.

Companies that do not comply with the designated timelines may face further FDA action, including enforcement action. If FDA takes enforcement action against a company that continues to market an unapproved product after the stated timeframes, the FDA may simultaneously take additional action regarding any other violative products that the company may be marketing, including any other unapproved drugs.

"These unapproved products have put consumers health in jeopardy, from reports of permanent vision loss with unapproved balanced salt solutions to a serious drop in blood pressure and increased heart rate from the topical papain products," said Janet Woodcock, M.D., director for the Center for Drug Evaluation and Research. "Consumers need to be assured that all drug products are manufactured according to the high quality standards required for FDA approval and that they are safe and effective."

About Unapproved Ophthalmic Balanced Salt Solutions (BSS):
Ophthalmic balanced salt solutions are used to irrigate the eye during surgery on the eye, including cataract and other ocular procedures. FDA has received reports of serious injuries to the eye from unapproved ophthalmic BSS. Users of these unapproved products have reported to FDA injuries including eye inflammation, cloudy vision, and permanent loss of visual acuity. Inspection of these products revealed contaminants and other product defects. Thus, FDA urges doctors and others who use these products to switch to approved versions of BSS made by Alcon and Akorn. FDA oversight of the manufacturing of ophthalmic BSS products helps to ensure that they are properly made and to reduce the risk of contamination and associated injuries.

Topical drug ointments containing papain are used to remove dead or contaminated tissue in acute and chronic lesions, such as diabetic ulcers, pressure ulcers, varicose ulcers, and traumatic infected wounds. Trade names for these products include Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox. Other products are marketed under the names of the active ingredients, for instance, papain-urea ointment.

The FDA is taking action today against these products because it has received reports of serious adverse events in patients using products containing papain. Reports include hypersensitivity (allergic) reactions that lead to hypotension (low blood pressure) and tachycardia (rapid heart rate). In addition, patients who are allergic to latex can also be allergic to papaya, the source of papain. Therefore, patients with latex sensitivity may be at increased risk of suffering an adverse reaction to a topical papain drug product.

FDA urges consumers who are using topical drug products containing papain, and who have questions or concerns, to contact their health care provider about discontinuing treatment with these products. There are a number of FDA-approved topical products that have been found safe and effective as wound healing agents and that do not contain papain.

"Removing unapproved topical drug products containing papain and unapproved ophthalmic balanced salt solutions is yet another step forward for patient safety," said Deborah M. Autor, director, Office of Compliance for CDER, FDA.

These actions are part of FDA’s unapproved drugs initiative. That initiative seeks to ensure that all drug products marketed in the United States are shown, through the drug approval process, to be safe and effective and to meet appropriate standards for manufacturing and labeling. This represents the eighth and ninth actions taken by the agency against a class of unapproved drugs since issuing a compliance policy guide (CPG) on marketed unapproved drugs in June 2006. The CPG describes FDA’s risk-based enforcement approach to marketed unapproved drugs.

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