FDA'a latest bulletin

[Chris Ryser]

In Today's Bulletin ...................................

FDA TO REVIEW PHAKIC INTRAOCULAR LENS PMA


The FDA will review a premarket approval (PMA) application for the Verisyse phakic intraocular lens, submitted by Ophtec USA and Advanced Medical Optics, on Feb. 5.

The PMA was accepted Aug. 22, 2003, and assigned expedited review status. The PMA application is for the correction of nearsightedness in phakic eyes in the range of -5.0D to -20.0D. The companies also plan to submit PMAs for the lens for the indications of treating farsightedness, astigmatism and cataracts, all of which are currently approved in Europe. The lens was launched in Europe in 2002.

Advanced Medical Optics holds global distribution rights to the lens and is the exclusive distributor of the product in North America and Japan. Ophtec markets the lens outside of North America and Japan under the name Artisan

[Chris Ryser]

In Today's Bulletin ...........................

STAAR SURGICAL UNCERTAIN ON LENS LAUNCH DATE


Staar Surgical Co. a medical device maker, said on Tuesday it was uncertain if it could release a new implantable contact lens by April as planned because of problems raised by federal regulators. The Monrovia, California-based company said it had met with the Food and Drug Administration last Wednesday to discuss corrective action it was taking after the FDA issued a warning letter to the company on Dec. 29.
Reuters
MSN Money

[Chris Ryser]

In Today's Bulletin ...........................

Advanced Medical Optics Seeks U.S. Okay for Lens
Wed February 4, 2004 04:15 PM ET

By Susan Heavey
WASHINGTON (Reuters) - Advanced Medical Optics and Ophtec USA will seek support from a U.S. panel of experts on Thursday for a new implantable lens that aims to eliminate or reduce nearsightedness.

Privately-held Ophtec USA, which makes the device, will present data for the Verisyse lens to Food and Drug Administration advisers. California-based Advanced Medical Optics holds global distribution rights for the lens.

The experts will decide whether or not to recommend approval to the FDA, which usually follows their advice.

Ophtec USA is a subsidiary of the Netherlands-based OPHTEC B.V. The lens is already marketed under the name Artisan in other countries.

Nearsightedness, or myopia, is a common refractive disorder that makes it difficult to see distant objects. According to the American Optometric Association, about 30 percent of Americans suffer from it.

The condition can be managed by wearing glasses or contact lenses, or corrected through laser procedures. Surgical treatment is rare.

Unlike cataract surgery, in which the clouded lens is removed and replaced, the man-made Verisyse is affixed to the natural one.

"Basically, think of it as ... taking your glasses and implanting them inside your eye," Advanced Medical Optics marketing director Ron Bache said.

Advanced Medical Optics said the lens is meant for those who have moderate to high myopia and is not meant to directly compete with laser techniques, which are generally used for those with low to moderate levels.

Just as laser surgeries are not recommended for people with certain eye conditions, Bache said Verisyse will not work for those who do not have enough space in their eye to fit the lens.

"It's another technology for the patient to choose from," Bache said.

FDA reviewers noted in a presentation prepared for the meeting that such a lens "expands the options" for patients and that the marketplace currently offers "more alternatives for correction in lower ranges of myopia than in higher ranges."

The procedure to implant the lens does carry risks, including possible corneal damage, retinal detachment and cell loss.

Advanced Medical Optics shares were down 72 cents at $22.43 in afternoon trading on the New York Stock Exchange.

[Chris Ryser]

In Today's Bulletin .........................

FDA PANEL BACKS DEVICE FOR MIDDLE-AGE VISION LOSS

A surgical procedure that can reduce the need for reading glasses by using radio waves to reshape the eye moved closer to U.S. approval on Friday. A scientific advisory panel unanimously urged the U.S. FDA to clear use of a device, made by privately held Refractec Inc., for treating the gradual decline in close-up vision that usually starts after age 40.
Reuters

Details:

FDA Panel Backs Device for Middle-Age Vision Loss
Fri February 6, 2004 05:12 PM ET
By Lisa Richwine GAITHERSBURG, Md.
(Reuters) -

A surgical procedure that can reduce the need for reading glasses by using radio waves to reshape the eye moved closer to U.S. approval on Friday. A scientific advisory panel unanimously urged the Food and Drug Administration to clear use of a device, made by privately held Refractec Inc., for treating the gradual decline in close-up vision that usually starts after age 40. While backing the product, panel members said patients need to know the procedure, called conductive keratoplasty or CK, can improve vision temporarily but will not completely free them of reading glasses. Some patients still will need them for certain tasks. "CK as a procedure for near (vision) is modestly effective at best," panel member Timothy McMahon said. Refractec said most patients were happy with the outcome. A year after the procedure, 94 percent of patients could read newspaper-sized type or smaller. The potential market for the procedure is vast because everyone experiences difficulty in seeing close-up images, such as words in a book or numbers on a cell phone, starting in middle age. The condition, called presbyopia, occurs because the lens in the eye loses flexibility over time, changing the way the eye focuses light. CK heats tissue around the cornea with radio waves. The tissue shrinks and creates a round band around the cornea to give the eye a steeper shape, which modifies the point of focus. The procedure takes about three minutes. The visual improvement is temporary because the eye still changes shape over time. Research so far suggests effects last "at least a couple years," said Dr. Daniel Durrie, a Refractec consultant. The panel urged several conditions for FDA clearance, including limiting the approval to use in patients with mild to moderate presbyopia. That includes about half of the people over age 40, Refractec spokeswoman Lauren Kanner said. The FDA usually follows the advice of its panels. The Refractec device, called the Viewpoint CK System, already is sold for treating patients with hyperopia, a much less common type of farsightedness. Doctors legally can use the system for presbyopia now, but FDA approval would allow the company to market it for that use. The procedure costs about $1,500, Kanner said. No serious or sight-threatening complications were reported during Refractec's study.

[Chris Ryser]

In Today's Bulletin ................................

Vol. 1, No. 28 Wednesday, Feb. 18, 2004

XILINX SYSTEM ENABLES RETINAL MAPPING

Xilinx Design Systems and Optos have developed the Optomap Retinal Exam system, the world's first ophthalmic device to produce a single high-resolution color image of the retina.
The system uses low-powered laser beams, which are scanned in two dimensions over the retina. The light refracted is detected and appears as a digital image on a conventional monitor screen in 0.25 seconds, and provides the optometrist with a view of up to 200 degrees of the retina.
The Optomap system aids early detection and management of eye diseases such as diabetes, age-related macular degeneration and glaucoma. Xilinx's Virtuex-II Pro is integrated with Roket IO technology to control the system processor, camera and other components to produce the visual image.

[Chris Ryser]

In Today's Bulletin ....................

COOPER DEALS WITH ARGUS FOR OPHTHALMIC DEVICES

Cooper acquired opthalmic technologies from Argus, including AlphaCor, an artificial cornea, and AlphaSpere, a soft orbital implant.

The Argus products will be developed and marketed by Cooper's newly formed ophthalmic surgery business unit, CooperVision Surgical. The terms of the deal were not disclosed.

[Chris Ryser]

In Today's Bulletin ..........................

J&J WARNS OF PIRATED 'SUREVEO' CONTACT LENSES IN RANCE

Johnson & Johnson warned that pirated, nonsterile contact lenses, which could lead to risks of infection to the wearer, have been discovered on the French market. The pirated lenses were sold under the brandname Sureveo, in packaging which ceased production at end-2003. The company said it has alerted the French health products security agency.

[Chris Ryser]

In Today's Bulletin ................................

ORTHOKERATOLOGY CONTACT LENSES CAUSE PERMANENT VISION LOSS IN CHILDREN


Children who wore contact lenses overnight as part of their orthokeratology regime developed corneal ulcers, resulting in corneal scarring and vision loss. Orthokeratology is a controversial, nonsurgical option for correcting the refractive error myopia, or nearsightedness.

Medical News Today

http://www.medicalnewstoday.com/index.php?newsid=6245

[Diane]

Re: In Today's Bulletin .............................

Chris Ryser said:
FDA APPROVES AUTOFOCUS LENSES

Eyeonics has received FDA approval for its first U.S. product, the Crystalens, an accommodating intraocular lens that allows patients to focus automatically at all distances.

According to the company, Crystalens is implanted during cataract surgery and accommodates like the eye's natural lens, allowing for clear vision without additional aids. Standard intraocular lenses restore only distance vision, with many patients still requiring glasses or contact lens to make up for other deficiencies.

I'm curious as to whether anyone has had any experience with this device/lens and what your opinions are about it.

Thanks,
Diane

[Chris Ryser]

In Today's Bulletin ...............................

GEBAUER ANNOUNCES ADVANCEMENT IN LESS-INVASIVE EPI-LASIK EYE SURGERY


Gebauer Medizintechnik announces positive clinical results for all of the first 100 Epi-LASIK patients treated in Europe using its minimally invasive, alcohol free, Epi-Lasitome. The Epi-Lasitome has received European CE Mark and based on its positive clinical evaluation, Gebauer has begun its commercial introduction in several European countries. The Company plans to file a 510(k) premarket notification submission with the FDA within the next 60 days seeking marketing clearance in the US.

[Chris Ryser]

In today's Bulletin ..................

Prototype computer allows blind to see
19 Mar 2004



Prototype system developed by Wright State computer engineer allows blind to “see”.

Researchers at Wright State University have developed a prototype device to help blind individuals “see.”

Nikolaos Bourbakis, Ph.D., Ohio Board of Regents Distinguished Professor of Information Technology at Wright State’s College of Engineering and Computer Science is the principal investigator. The project is a cooperative venture with Arizona State University (ASU).

“Our object is to develop intelligent assistants that can help blind and visually impaired individuals efficiently conduct daily tasks, such as reading a book or newspaper and efficiently accessing the Web and participating in classes,” explained Bourbakis, who has been involved in computer engineering eye research for 20 years.

Tyflos, the Greek word for blind, is the name of the portable, wearable device Bourbakis has developed. The partnering project at ASU is called iLearn. A tiny camera is mounted to glasses and connected by a thin wire to a modified lap-top computer the individual carries on his or her back.

The Tyflos system operates by identifying the images “seen” by the camera and converting this to audio information the subject hears from small wires connected from the backpack to the ear. A small microphone is attached for receiving commands or requests from the user.

Bourbakis, who started on this project in 1995, plans to work with the WSU Office of Disability Services to test the device’s capabilities on visually impaired students.

In addition, he is working on an extension of the Tyflos system that enables blind individuals to independently navigate their working and living environments.

Two future extensions of the Tyflos system will offer writing and drawing assistance that will enable the visually impaired to visually express their artistic talent beyond the usual levels.

“The Tyflos camera captures images from the surroundings, and the portable computer reconstructs the 3D space for motion detection, body tracing, face recognition and moving objects,” explained Bourbakis, who also directs the Information Technology Research Institute and the Assistive Technology Research Laboratory at Wright State.

“This will make it possible for the blind and vision impaired to improve their independent mobility and social interaction, while succeeding in their professional endeavors. It is a great feeling for visually impaired people to make the first call in a conversation, like hi John, rather than waiting for somebody to talk to them. We are using state-of-the-art computer vision and robotics technology that will help the users tremendously in recognizing faces, objects, reading books, surfing the Web and safely navigating in dynamic environments.”

He said the applications of the project are substantial, with an estimated 45 million blind individuals in the world, according to a World Health Report.

Funding for the project includes a $1.1 million National Science Foundation grant to ASU and Wright State. This was awarded last fall for four years.

For more details on Tyflos, contact Bourbakis at (937) 775-5138 or bourbaki@cs.wright.edu.

[Chris Ryser]

In Today's Bulletin .....................

FDA SET TO APPROVE PRESBYOPIA TREATMENT

Refractec is set to announce that it has received FDA approval to market a procedure that uses radio-frequency energy to treat presbyopia, the close-vision problem that afflicts most adults by age 50.

The procedure — conductive keratoplasty — uses radio waves to reshape the cornea and bring near vision back into focus.

[Chris Ryser]

In Today's Bulletin .................................

FDA APPROVES NEW LABEL CLAIMS FOR LENS IMPLANT

Pfizer announced the FDA has approved the new labeling claims of the first intraocular lens implant to reduce postoperative spherical aberrations and improve night driving performance.

The Tecnis lens was specifically designed to improve functional vision of cataract surgery patients.

[Chris Ryser]

In Todays Bulletin ..................................

'LASER VISION' OFFERS NEW INSIGHTS

A system that projects light beams directly into the eye could change the way we see the world. US firm Microvision has developed a system that projects lasers onto the retina, allowing users to view images on top of their normal field of vision. It could allow surgeons to get a bird's eye view of the innards of a patient, offer military units in the field a view of the entire battlefield and provide mechanics with a simulation of the inside of a car's engine.

http://news.bbc.co.uk/1/hi/technology/3647437.stm

[Chris Ryser]

In today's Bulletin .........................

Vol. 1, No. 82
Tuesday, May 4, 2004

ADVANCED MEDICAL OPTICS: LICENSING AGREEMENT WITH QUEST VISION
Advanced Medical Optics (AMO), developer, manufacturer, and marketer of ophthalmic surgical and eye care products, announced a one-year research and evaluation licensing agreement with Quest Vision (QV), a California-based research and development company, to develop accommodating intraocular lens (IOL) designs, which will give AMO a minority interest in QV with an option to purchase the company after one year.
The accommodating IOL designs are being developed to address presbyopia, the progressive loss of the natural lens' ability to change focus from far to near objects caused by the aging of the eye's natural lens, by mimicking the qualities of the eye's natural crystalline lens by accommodating in response to changes in the eye's natural ciliary muscle mechanism.

Under the agreement, AMO will have access to a number of issued and pending patents for various design approaches that encompass both axial movement and shape-changing technology. No other terms of the agreement were disclosed.





AcrySof(R) ReSTOR(R) Intraocular Lens Demonstrates Ability to Provide Excellent Near and Distance Vision After Cataract RemovalPR Newswire - Monday, May 03, 2004
- Surgeons present data on IOL at ASCRS meeting FORT WORTH, Texas, May 3, 2004 /PRNewswire-FirstCall via COMTEX/ -- Alcon, Inc. (NYSE: ACL) reported updated clinical results on the AcrySof(R) ReSTOR(R) intraocular lens (IOL) that demonstrate its ability to substantially restore a cataract patient's ability to see both near and distant objects without the aid of reading glasses or bifocals. Today, the vast majority of patients who undergo cataract surgery receive monofocal IOLs, which typically require them to carry around reading glasses so they can read a newspaper, menu or medicine bottle, or do other things that require close vision such as sewing, building models and playing cards.

"These data are extremely promising, considering our nation's dependence on reading glasses and bifocals to see near objects in general and especially following cataract surgery," said James A. Davison, MD, FACS, of Marshalltown, IA, an investigator in the study, who presented Phase III study data at the American Society of Cataract and Refractive Surgery (ASCRS) annual symposium in San Diego. Dr. Davison added, "I believe the AcrySof(R) ReSTOR(R) lens will greatly improve quality of life for the vast majority of patients who receive it by eliminating or greatly reducing their dependence on reading glasses after surgery."

The AcrySof(R) ReSTOR(R) IOL represents breakthrough technology because it delivers consistent high-quality pseudoaccommodative vision across the entire visual spectrum due to the unique, proprietary and innovative optics of the lens, rather than relying on unpredictable and variable mechanical processes to achieve accommodation. This lens achieved CE mark status April 4, 2003 and is currently being implanted in patients outside the U.S. The Pre-market Approval application has been submitted to the FDA and Alcon anticipates this technology will be available in the U.S. in 2005.

"Based on the response by doctors and patients outside the U.S., we believe AcrySof(R) ReSTOR(R) will have a positive impact on our sales of IOLs," said Cary Rayment, Senior Vice President, Alcon United States. "Reducing the need for reading glasses after lens removal, without compromising distance vision, has been a goal of ophthalmology for many years, and it looks like the range of accommodative effect and predictability of this lens may finally get us there."

Study Methods and Results

Multi-center clinical studies were conducted in the United States and Europe to establish the safety and effectiveness of the AcrySof(R) ReSTOR(R) IOL. A total of 566 patients received the AcrySof(R) ReSTOR(R) IOL and 194 received the AcrySof(R) monofocal IOL as a control. The mean age for the total population was 69 years. In the study, 99 percent of patients who received the AcrySof(R) ReSTOR(R) and 98 percent of patients who received the monofocal IOL achieved distance visual acuity of 20/40 or better, without correction by contacts or glasses, with both groups exceeding the FDA grid value of 92 percent for this measurement. Furthermore, 88 percent of patients who received the AcrySof(R) ReSTOR(R) IOL achieved distance visual acuity of 20/25 or better without correction by contacts or glasses compared to 92 percent for the monofocal control group, reflecting that the two lenses were statistically equivalent at this level of distance visual acuity.

As for near vision, following bilateral implantation (implantation in both eyes), 74 percent of patients receiving the AcrySof(R) ReSTOR(R) achieved near visual acuity of 20/25 (J1) or better without correction by contacts or glasses, while only 14 percent of the monofocal control group achieved this level. In addition, 85 percent of the AcrySof(R) ReSTOR(R) IOL patients achieved functional binocular uncorrected intermediate vision (20/40 or better (J3) measured at standard 60 cm computer screen working distance) compared to 67 percent of monofocal control patients. J1 means patients can read the very small stock quotes in the newspaper, while J3 means patients can read the normal newspaper type size.

This exceptional visual performance was independent of pupil size and was accomplished by the optics of the lens without physical movement of the lens inside the eye, making visual outcomes highly predictable. As a result, 80 percent of AcrySof(R) ReSTOR(R) patients reported never using glasses for either near or distance vision, compared to only 8 percent of the monofocal control patients. This is the first time this level of spectacle independence has been achieved.

Contrast Sensitivity

Contrast sensitivity data presented at this meeting indicated that at lower spatial frequencies there was no clinically or functionally significant difference between AcrySof(R) ReSTOR(R) and monofocal control subjects. Other studies indicate that these lower spatial frequencies are most important in terms of vision related to everyday life skills, such as walking, driving, and reading.

About AcrySof(R) ReSTOR(R) IOL

The AcrySof(R) ReSTOR(R) IOL is a foldable intraocular lens. Its unique apodized diffractive optic design provides pseudoaccommodation, which is the ability of a lens to focus light correctly on the retina for images at various distances without mechanical movement of the lens. This optic design results in highly-predictable visual acuity results, thus allowing a patient to experience reduced dependence on glasses or contacts for their daily requirements for near, intermediate and distance vision. The AcrySof(R) ReSTOR(R) IOL is made of the same highly-biocompatible acrylic material as Alcon's market-leading AcrySof(R) family of intraocular lenses, which have been implanted in more than 17 million human eyes since 1991. The new IOL is particularly well-suited for patients who wish to reduce their dependency on eye glasses once their lens is removed, as occurs in cataract surgery.

About Alcon

Alcon, Inc. is the world's leading eye care company. Alcon, which has been dedicated to the ophthalmic industry for over 50 years, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens solutions and other vision care products that treat diseases, disorders, and other conditions of the eye.

Caution Concerning Forward-Looking Statements. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by our forward- looking statements. These statements reflect the views of our management as of the date of this press release with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that might cause future results to differ include, but are not limited to, competition from other drugs already on the market or competitive drugs that reach the market in the future, challenges inherent in new product manufacturing and marketing, developments in legal cases and government regulation and legislation. You should read this press release with the understanding that our actual future results may be materially different from what we expect. Except to the extent required under the federal securities laws and the rules and regulations promulgated by the Securities and Exchange Commission, we undertake no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.