at press time
Tecnis Lens Gets NTIOL Status
FDA Cites Advantages for Night Driving.

The Tecnis IOL from AMO.

Advanced Medical Optics, Inc. (AMO) has announced that the Tecnis foldable IOL has been designated as a New Technology Intraocular Lens (NTIOL) by CMS. The designation follows labeling claims approved by the FDA in April 2004 that the Tecnis reduced postoperative spherical aberrations compared to lenses with spherical optics, and also improved night driving simulator performance. The NTIOL designation includes both the acrylic and silicone platform Tecnis lenses.

An NTIOL is defined as an IOL that CMS determines has been approved by the FDA for use in labeling and advertising the IOL's claims of specific clinical advantages and superiority over existing IOLs with regard to reduced risk of intraoperative or postoperative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision or other comparable clinical advantages.

In its final notice published in the Federal Register, CMS stated, "CMS approves AMO's claims of clinical advantages and superiority of the Tecnis IOL for ocular spherical aberrations and simulated night driving. We find the AMO Tecnis lenses models Z9000, Z9001 and ZA9003 meet the NTIOL definition and are to be given the new NTIOL classification of Reduced Spherical Aberration."

The Tecnis IOL
is the only lens approved for NTIOL reimbursement status, which provides for additional Medicare reimbursement of $50 per lens for ambulatory surgical centers, which perform more than half of all cataract surgeries in the U.S. Previously, the now-discontinued Array multifocal had NTIOL status.

"Tecnis NTIOL status confirms the unique design of the lens and the very real benefits it provides to patients," said Ralph Chu, M.D., a cataract/refractive specialist in private practice in Minneapolis and an early adopter of the Tecnis IOL technology. "The unique modified prolate technology increases the patient's functional vision in varying light conditions, which is critical for everyday tasks conducted in low-light conditions, such as reading, driving at night or in the fog."

Mark Packer, M.D., clinical assistant professor of ophthalmology at the University of Oregon and clinical study investigator for several Tecnis IOL studies, including a driving simulation study, said, "The Tecnis lens is the only IOL available that was specifically designed, based on wavefront measurements of a representative sample of the population, to fully compensate for the spherical aberration of the cornea."

GIVING BACK: Making a Difference in Nigeria
Dr. Marilyn Miller's Commitment is Long-Term.
By Leslie Goldberg, Assistant Editor

Dr. Miller and friends in Abak.

When Foreign Ophthalmologic Care from U. S. (FOCUS) was founded in 1962 by three Chicago-area ophthalmologists, Marilyn Miller, M.D., a Chicagoan who later got involved with the volunteer organization, could not have guessed what a big part she would play in its future. FOCUS, which provides vital medical and surgical ophthalmic services and support in areas of extreme need, has a mission that includes recruiting volunteer physicians, collecting donated medical supplies and raising money to fund its work.

The first FOCUS volunteers served in Haiti. Later, he organization's work moved to Guatemala and, for more than two decades, FOCUS has been based in a remote area in Abak, Nigeria.

In 1990, the Mercy Eye Center was opened in Abak thanks to collections of private funds by FOCUS and local donations. Initially, the volunteer doctors saw anywhere from 75 to 300 patients daily, treating cataracts, advanced glaucoma, traumatic globe ruptures, retinoblastomas and retinal detachments.

More recently, FOCUS has shifted to a "train the trainer" approach. "We started with volunteer delivery of health care and have developed into a regional training site. I firmly believe that the best way to assist in improving eye care in developing and mid-income countries is to participate in the training of healthcare professionals," says Dr. Miller.

"Our interest now is to recruit teachers who are willing to work with residents to develop their skills and knowledge. This is how programs evolve. You start out going to a place devoid of anything and you work as hard as you can to deliver eye care. In the long run, you can help more people if you are able to train local professionals," says Dr. Miller, who first volunteered her time at the rural clinic in 1982. Today, she is the president of FOCUS.

"Marilyn is an incredible woman," says colleague James Standefer, M.D. "She is very committed to FOCUS. She has helped Mercy Hospital Eye Center to grow and flourish under her presidency, and has people scattered throughout the world through both training and administering eye care."

Certified American ophthalmologists may volunteer for service in Abak. The minimum period of service is 2 working weeks. You should apply at least
3 to 6 months in advance of the time you wish to serve.

To find out more about becoming a FOCUS volunteer, or to donate funds or medical supplies, call Dr. Miller at (312) 996-7445 or visit http://focuseye.org.

In addition to working with FOCUS, Dr. Miller is active in assisting training and education programs sponsored by various non-governmental organizations, to prevent blindness in developing countries. Dr. Miller mentors young pediatric ophthalmologists around the world and has also been an invited lecturer/clinician in China, Bulgaria, Pakistan, India, Brazil, Afghanistan, Myanmar, Morocco, Bangladesh and Libya.

In October 2005, Dr. Miller was presented with the Outstanding Humanitarian Service Award by the American Academy of Ophthalmology. Dr. Miller is on the Advisory Board of Directors of the Foundation of the American Academy of Ophthalmology (FAAO) involved in international programs. She was President of the American Ophthalmological Society, the Chicago Ophthalmological Society, and the American Association for Pediatric Ophthalmology and Strabismus (AAPOS), and currently chairs the AAPOS International Affairs Committee. She also serves on the Boards and Committees at the Smith-Kettlewell Eye Research Institute, Helen Keller International, ORBIS International (pediatric ophthalmology programs), and the AAPOS Children's Eye Care Foundation. She has served for many years on the Medical Advisory Board for the Division of Specialized Care for Children.

Alimera Sciences: A Step At A Time
Experienced Managers Guide New Eyecare Company.
By Jacqueline Zummo, Medical Editor

Dan Myers and several other former key management team members of Novartis Ophthalmics started Alimera Sciences in Atlanta in 2003 after the decision was made to close the Novartis Ophthalmics office in Georgia and move it to New Jersey. Their desire to stay in Atlanta sparked an interest in Myers and some co-workers to start a company that would address the unmet needs of the anterior segment of the eye.

Myers says there has always been an interest from large pharmaceutical companies in blockbuster drugs that treat the anterior segment, but before Alimera Sciences there was no company that zeroed in on smaller, niche products that would improve practice efficacy and the lives of patients. 

"Like anything, change is good. Sometimes things move us out of our comfort zone and in turn end up being a blessing in disguise. This is the case with Alimera Sciences," comments Myers.

Sound Finances

In the first 90 days of the company, the management team and their vision for the company brought in $1.7 million, allowing the company to get itself off the ground. Less than 1 year after Alimera Sciences incorporated, it had secured $27 million in start-up capital through Series A financing from four different venture capitalist firms, including Intersouth Partners, BA Venture Partners, Domain Associates and Polaris Venture Partners. All four venture capitalist firms made an equal investment, securing each company a seat on the Alimera Sciences' board of directors.

Alimera Sciences' first product was an over-the-counter dry-eye treatment, Soothe. This emollient eye drop works to re-establish the protective lipid layer of the tear film. Its success paved the way for the hiring of a 15-member sales force. "This new type of eye drop is now in every major chain in the country and is supporting our sales team and the 60 sales representatives from Vistakon Pharmaceuticals, with which we have a co-marketing agreement," notes Myers. "This spring, we plan to hire another 15 sales representatives to support two new products that we will be launching this year for the anterior segment around refractive surgery and allergy," adds Myers.

Another Alimera Sciences product called Medidur, a sustained-release implant for the treatment of diabetic macular edema, is now in phase 3 trials. "The evolution of the company is such that it can be compared to the evolution of R&D in the eye. Start with lesser products in the front of the eye for the anterior segment, enter the phase 3 trials with Medidur, and move into the more significant and potentially more valuable drugs for diseases of the retina," says Myers.

The Future Looks Bright

Alimera Sciences' CEO Dan Myers

Alimera Sciences is looking to be a full-line ophthalmic company over the next 5 years. Starting with Medidur, and moving into other options to leverage delivery technology that it has acquired from Control Delivery Systems, is what Alimera management is hoping will bring the company into the posterior segment category. "We have positioned ourselves well in regard to drug delivery to the posterior segment of the eye. We know there are better ways to deliver drugs to the back of the eye and we think we have positioned ourselves to add value there," says Myers. "The biggest positive in our vision, as I see it, is that we will have the ability to treat all eye disease, both anterior and posterior segment."

With an experienced executive team, and one successful product already under its belt, Alimera Sciences is a company worth watching.

IN THE NEWS

►Fee cut rolled back. A 4.4% across-the-board cut in fees paid to physicians by Medicare was rolled back in early February after the House passed a budget reconciliation measure. The House had failed to take action on reconciliation in late December. The reconciliation legislation was necessary to bring the House and Senate into agreement on provisions of the overall federal budget.

Physicians will be reimbursed at the same levels as provided for in the 2005 Physician Fee Schedule, with the rate freeze retroactive to Jan. 1, 2006. CMS will automatically reprocess all claims submitted for services provided in 2006, so practices will not have to file new claims.

►Sustained-release Macugen. OSI Pharmaceuticals, which purchased Macugen developer Eyetech Pharmaceuticals late last year, is now partnering with PRP Pharmaceuticals, Inc. to collaborate on the development of sustained-release delivery of Macugen using PRP's proprietary ProPhase encapsulation technology.

In related news, Macugen was recently approved for use in countries of the European Union.

►Lucentis/Macugen combo? OSI Pharmaceuticals CEO Colin Goddard, Ph.D., recently proposed at a Merrill Lynch forum that Macugen be used in concert with Avastin or Lucentis. He suggested that one of the early-acting Genentech drugs could be used to treat the acute phase of wet AMD, with Macugen then being used for longer-term maintenance therapy.

►Lucentis prevails in study. Genentech, Inc. has announced positive 1-year results from its second pivotal phase 3 study of the investigational drug Lucentis in patients with wet AMD. Data from the ANCHOR study comparing Lucentis to Visudyne photodynamic therapy (PDT) showed a difference in mean change in visual acuity of 18 letters for patients treated with 0.3 mg of Lucentis and 21 letters for patients treated with 0.5 mg of Lucentis from study entry compared to those treated with PDT at 12 months.

In the first year of this 2-year study, patients treated with Lucentis gained an average of 8.5 letters in the 0.3 mg dose group and 11 letters in the 0.5 mg dose group compared to patients treated with PDT, who lost an average of 9.5 letters.

►Xibrom OK'd for pain. ISTA Pharmaceuticals, Inc. said the FDA has approved ISTA's supplemental New Drug Application for Xibrom, expanding Xibrom's indications to include the treatment of pain following cataract surgery. Xibrom, a topical, twice-daily NSAID, was originally approved by the FDA in March 2005 for the treatment of ocular inflammation following cataract surgery. ISTA launched Xibrom in the United States during the second quarter of 2005. OM

IN MEMORIAM

Bob Boucher

On February 13, 2006, my business partner and dear friend Bob Boucher, 59, passed away after battling a serious illness for the past few months. Bob was a wonderful role model for all who knew him. His business savvy, knowledge and experience impacted the lives of so many in both vision care and business publishing over many years.

A 1968 graduate of Bucknell University, Bob started his business publishing career at The Chilton Company in 1969. During the next 23 years, Bob worked for The U.S. Business Press, Gordon Publications and served as President and CEO of Gralla Publications in New York. In 1992, Bob was recruited by the equity firm Brentwood and Associates to form Cardinal Business Media as President and CEO. Over the next 5 years, Cardinal grew to be a dominant player in business publishing, serving numerous specialty areas including the optical and vision care markets. In 1997, I had the privilege of acquiring the vision care titles and a number of technology publications with Bob, and Boucher Communications, Inc. was formed. The business grew steadily and by 2005, we were the publishers of five leading eyecare-related publications, Ophthalmology Management, Optometric Management, Eyecare Business, Contact Lens Spectrum and our newest publication, Retinal Physician, which we launched in 2004. Along with his tireless work in the office, Bob was also active on several boards, as well as the American Business Media.

In September 2005, we sold our company to Wolters Kluwer, a leading provider of healthcare communications around the world. As I look back over our years together in business, I realize how fortunate I was to know such a great man. Speaking for our employees, colleagues and many industry friends, Bob will be missed by everyone he touched in his life.

Bob is survived by his wife, Mary Lou, his sons, Michael and Brian, his parents, Robert N. Boucher, Sr., and Charlotte K. Boucher, five grandchildren, and his brother, David M. Boucher.

The family is requesting donations in Bob's memory be made to the American Brain Tumor Association. 1-800-886-2282 or hope.abta.org.

Pat Herron
Executive Publisher
LWW VisionCare