CRSToday Europe News — January 2008

Promising Initial Results For New Diffractive IOL
According to data gathered from a multicenter French study on the new Diffractiva-s diffractive IOL (HumanOptics AG, Erlangen, Germany), good near vision is delivered with this optic. Four ophthalmology centers evaluated the three-piece silicone implant, which contains nine diffractive zones. Participating surgeons reported stable centration, with no halos or glare, in 100% of eyes (80/80). The lens allowed patients to read small newspaper print, according to a company news release. Intermediate and far vision results for the lens are still under investigation.

"The Diffractiva-s is safe and easy to handle, as the optics unfold smoothly and [in a controlled manner]. The implant provides good near visual acuity without compromising the contrast sensitivity," said Jean-Louis, MD, of St. Jean-de-Luz, France.

Results from the multicenter study will be released during upcoming congresses, including the French Society of Ophthalmology meeting in Paris. The company hopes that additional data from multicenter studies in Germany and other countries will add to the comprehensive clinical evaluation of the new implant.

HumanOptics literature stated that "the diffractive IOL for capsular bag implantation is the first product of a family of diffractive implants, which will be joined by further solutions, giving more alternatives to surgeons as far as the implantation location goes. A next step, after the successful launch of the Diffractiva-s, will be the clinical evaluation of a diffractive sulcus implant."

"On a personal series of the first 11 patients, all obtained Parinaud 2, with a score far comparable with monofocal lenses. These impressions will have, of course, to be consolidated by the ongoing multicenter evaluation, but [the performance] seems to be promising," said Jean-Paul Chevalier, MD, of Toulouse, France.

Microincisions Have Little Impact on Optical Quality
Microincision cataract surgery (MICS) does not degrade the optical quality of the cornea or induce corneal astigmatism, according to a study by Jorge L. Alió, MD, PhD, and colleagues from the Vissum Instituto Oftalmologico de Alicante, Spain.

The study, published in the Journal of Cataract and Refractive Surgery, included 25 eyes (25 patients) with nuclear or corticonuclear cataracts (grade 2–4 on the Lens Opacities Classification System III). An Acri.Tec Acri.Smart 48S (Carl Zeiss Meditec AG, Jena, Germany) was implanted in all eyes through 1.6- to 1.8-mm clear corneal incisions on the axis of the positive corneal meridian.

Researchers found that the total root mean square after MICS decreased slightly from a mean of 2.15 ±2.51 µm to 1.96 ±2.01 µm postoperatively (P=1.00). The difference in corneal astigmatism between the pre- and postoperative measurements, along with cases of Seidel aberrations, coma, or higher-order aberrations, was not statistically significant.

"Although the changes in the cornea were not statistically significant," authors wrote, "there were slight differences between the preoperative and 1- and 3-month follow-up.

"The mean change in corneal astigmatism preoperatively to 3 months was -0.19 ±0.40 D, with little difference between the 1- and 3-month points. This indicates that [MICS] provides a stable incision for up to 3 months postoperatively ? and thus provides a neutral incision in terms of astigmatism."

This data suggests that MICS does not degrade the corneal optical quality or modify corneal astigmatism, even in the axis, the authors reported. "Sub–2.0-mm surgery improves control of the optical performance of the human eye," they wrote.

Cataract Operations Cost Effective in the Long-Term
Whether first-eye cataract surgery is cost effective or not depends on the length of the patient's remaining lifetime. According to a study published in the British Journal of Ophthalmology, patients did not perceive the surgery as cost effective the first 12 months after the operation.

The study also found that surgery improved patients' health status and "demonstrated benefits in visual acuity, contrast sensitivity, stereopsis, activity, anxiety, depression, confidence, visual disability and handicap, and reduced fall rates," said Tracey H. Sachs, MD, in an interview with Reuters Health.

The study included 306 women aged over 70 years old. All women had bilateral cataracts and were randomized to cataract surgery within 4 weeks (group one) or to a control group (group two) that waited 12 months. When cost-effectiveness was compared at 1 year, the mean total cost for group one was £3,250 per patient compared with £1,247 per patient in group two.

The mean number of falls per patient in group one and two was 0.934 versus 1.390, respectively.

At 1 year, the cost effectiveness for surgery was £35,704 per quality-adjusted life-year gained. This cost exceeds the currently accepted threshold of willingness to pay in the United Kingdom. When compared with the expected remaining lifetime of the patient, however, the incremental cost-effectiveness ratio was £10,382—well below the willingness-to-pay ratio of £30,000.

First-eye cataract surgery, the study's authors concluded, did not appear to be cost effective in the short-term, but the cost effectiveness increased as time increased.

Ista Pharmaceuticals Submits New Drug Application
Ista Pharmaceuticals, Inc. (Irvine, California) submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Xibrom QD (bromfenac ophthalmic solution) as a treatment for inflammation, pain, and photophobia following cataract surgery.

Xibrom is a once-daily, topical NSAID compound for the treatment of ocular inflammation and pain; it is already FDA-approved as a twice-daily NSAID.

Alcon Announces New Share Repurchase Program
The Alcon Laboratories, Inc. (Fort Worth, Texas) board of directors approved a new share repurchase program that allows for the purchase of up to $1.1 billion shares of outstanding common stock targeted over 12 months.

The $1.1 billion share repurchase program provides for a prorata purchase of shares from the company's majority shareholder, Nestle, S.A (Vevey, Switzerland). The company plans to finance the purchases with excess cash and investments on hand and with funds generated from operations.

"The increased authorization for share repurchases and the prorata participation by Nestle in the new program together allow Alcon to improve its capital structure without materially reducing its public float," said Richard Croarkin, Alcon's Senior Vice President of Finance and Administration.

This new program is in addition to the company's existing repurchase program, which had authorized repurchasing up to 2.8 million shares as of December 2007.

Carl Zeiss Meditec Earnings Jumped From Last Fiscal Year
Carl Zeiss Meditec AG saw a 45.9% increase in revenue and earnings, despite higher investment in its new products and sales expansion in the 2006/2007 fiscal year. Consolidated revenue of the medical technology company climbed to ?569.7 million on the German Stock Exchange from ?390.6 million in the previous year. Additionally, the gross margin increased 4.9 percentage points to 51.9%.

The strong business growth compensated for the company's increased number of shares, which more than doubled year-on-year, according to a company news release.

"Although we have significantly increased our investments in new products and the expansion of sales and marketing activities compared with last year, earnings before interest and taxes increased hand-in-hand with revenue," said Ulrich Krauss, President and Chief Executive Officer of Carl Zeiss Meditec AG, in the news release.

According to a company report, Carl Zeiss Meditec generated almost half of its revenue in the United States.

In the future, Carl Zeiss Meditec "will be expanding our existing business with new products and improved customer care. Furthermore, we will be using our good market position in the core markets to advance into attractive neighboring segments," Mr. Krauss said.

$50 Million Funding Initiative to Eliminate River Blindness in Africa
The World Bank (Washington, District of Columbia) and Merck & Co., Inc. (Whitehouse Station, New Jersey) announced an initiative to raise $50 million USD to help eliminate river blindness (onchocerciasis), a leading cause of preventable blindness, in 28 African countries.

Merck has pledged up to $25 million—approximately half of the funding needed over the next 8 years to help eliminate this public health problem, which puts the health and livelihood of 100 million people at risk worldwide, mostly in sub-Saharan Africa. The disease causes intense itching, disfiguring skin disease, and eye lesions that often result in permanent blindness, according to a joint news release from the organizations.

According to the same report, the World Bank will work with Merck and other partners to raise the remaining $25 million. This $50 million in new funding will supplement the $20 million the bank already raised from international partners, for a total of $70 million to support the program through 2015.

"With this public-private partnership, we can eliminate river blindness in Africa and free dangerous lands for productive agriculture to overcome poverty," said Robert B. Zoellick, World Bank President.

Merck has pledged the funds to augment their donation of the only well-tolerated medication that treats river blindness, according to the release. "No one group can tackle this disease alone. With this initiative, more than 100 million people will receive Mectizan annually," the company news release said.

Spread by black flies found near river banks, river blindness has been largely eliminated in 10 of the 11 targeted West African countries under the first large-scale aerial spraying program started by the World Bank and World Health Organization (WHO) in 1974. This has enabled resettlement and cultivation on over 25 million hectares of fertile land, boosted farm productivity and rural incomes, and prevented 600,000 people from going blind, according to WHO.

Merck has donated more than 530 million doses of Mectizan (ivermectin, MSD) since 1987, at a value of $2.7 billion. In 1995, the World Bank, the WHO, and nongovernmental organizations established the African Program for Onchocerciasis Control (APOC) to oversee successful delivery of Mectizan through community-directed treatment programs in the 19 non-West African countries affected by river blindness.

The program is the longest-running medicine donation commitment in history and currently reaches approximately 70 million people each year for the treatment of river blindness, according to the news release.

Additionally, the APOC and its partners have pioneered a community-based delivery strategy through which 350,000 trained community volunteers distribute Mectizan and other health services such as insecticide-treated bed nets for malaria control to 120,000 remote communities.

Advanced Medical Optics Named New President, Moves IntraLase Corp.
Advanced Medical Optics, Inc., (AMO; Santa Ana, California) announced that Richard (Randy) A. Meier has replaced James V. Mazzo as president. Mr. Meier retained his existing Chief Operating Officer title and responsibilities, which include leadership of the company's eye care and cataract/implant businesses, global customer services, and manufacturing operations. Mr. Mazzo will remain the company's Chairman and Chief Executive Officer.

Mr. Meier joined AMO in 2002 as Corporate Vice President and Chief Financial Officer.

In a separate announcement, the company noted that it would be moving the recently acquired IntraLase Corp. from Irvine, California to plants locationed in San Francisco and Puerto Rico. The company said it would take a pretax charge of $11 million and $13 million to move the operations during the next three quarters, according to a Securities and Exchange Commission filing.

AMO purchased IntraLase for $808 million in 2007.