at press time

QLT to Acquire Atrix Labs
Atrix Technology has Ophthalmic Applications.

When QLT Inc. recently said it planned to acquire Atrix Labs for about $855 million in cash and stock, analysts saw the move as a way for QLT to beef up its R&D pipeline in urology, oncology and dermatology, three therapeutic areas of strategic interest. Until now, QLT has primarily been known as the co-developer of Visudyne therapy for wet AMD.

However, Atrix, which is headquartered in Fort Collins, Colo., could also expand QLT's presence in ophthalmology with a potentially promising new treatment for diabetic retinopathy.

Atrix is currently developing sustained-release formulations of octreotide, a small peptide that suppresses the release of growth hormone from the pituitary gland. Currently marketed octreotide products are approved for use in patients with carcinoid syndrome, VIP tumors and acromegaly. Octreotide also has antiangiogenic properties that inhibit the formation of new blood vessels.

"Given octreotide's antiangiogenic activity, and its capacity to down-regulate the growth hormone/insulin-like growth factor-1 axis, investigators have become increasingly interested to test this peptide as a systemic agent to slow down the progression of diabetic retinopathy," says Stephen Warren, M.D., vice president of R&D and chief scientific officer of Atrix. "A major challenge has been to develop a drug-delivery system that's sufficiently robust to constantly release therapeutic levels of octreotide into the blood over days or weeks.

Atrix believes it may have such a drug delivery system in Atrigel. Atrigel, which is already being used in several of Atrix's marketed products, has many potential sustained-release applications. It's a bioabsorbable polymer system that's mixed with a drug, peptide or protein just prior to subcutaneous injection. The Atrigel/drug mixture enters the subcutaneous tissue as a liquid and almost immediately transforms into a solid pellet that gradually releases drug as the polymers are absorbed.

Dr. Warren says an almost endless number of Atrigel formulations can be prepared to release drugs, peptides or proteins over a period ranging from 2 weeks to 6 months.

Atrix is currently conducting early clinical studies with a 1-month formulation of Atrigel/octreotide. The company is also developing a 3-month formulation, which should be in the clinic sometime next year.

"Published studies indicate that octreotide has definite biological activity in diabetic retinopathy, and our Atrigel-based products have an excellent safety profile, based upon the performance of our FDA-approved products," notes Dr. Warren. "We believe Atrigel/octreotide may help to solve a key drug-delivery problem that has precluded the use of octreotide as a systemic treatment for diabetic retinopathy."

Dr. Warren says that there are many other potential systemic and local applications for the Atrigel drug-delivery technology platform, including its use to deliver drugs into various ocular tissues.

"Preclinical studies show that Atrigel can be injected into numerous tissues throughout the body, including tissues in and around the eye. It appears to be well-tolerated in most sites of injection," he notes.

IN THE NEWS

PureVision settlement. Bausch & Lomb and CIBA Vision Corporation, the eye care unit of Novartis AG, said they have reached a settlement agreement that resolves disputes between the two companies in patent infringement lawsuits and associated patent proceedings related to silicone hydrogel contact lens materials.

Under the terms of the agreement, the companies have agreed to cross-license rights to their silicone hydrogel contact lens technologies. Bausch & Lomb will pay CIBA Vision a royalty on net U.S. sales of its PureVision brand contact lenses until 2014 and on net sales outside the United States until 2016. Specific terms of the agreement are confidential.

The agreement, effective July 1, resolves several patent lawsuits in the United States, as well as other lawsuits and patent proceedings that had been brought in Europe and Australia.

Bausch & Lomb, which in 2002 was ordered by a federal court to stop U.S. production of PureVision 30-day- and-night contact lenses, can resume sale and manufacture of PureVision lenses in the United States on April 27, 2005, upon expiration of CIBA Vision's Harvey patent, which was upheld in the 2002 ruling. PureVision brand lenses will continue to be available outside the United States. CIBA Vision's Focus Night & Day 30-day-and-night contact lenses continue to be available worldwide.

No generic Xalatan. Pfizer has prevailed in a patent infringement suit in which Par Pharmaceutical was seeking to sell a generic version of Pfizer's glaucoma medication latanoprost (Xalatan).

The U.S. District Court for New Jersey upheld Pharamacia's original "504" patent on the formulations and uses of latanoprost, which expires in March 2011. Par now can't win approval for a generic version of Xalatan until March 2011.

PDT laser. Miravant Medical said the FDA has accepted for filing and granted expedited review status to the company's Premarket Application for the IRIS Medical OcuLight 664 Ophthalmic PDT Laser used to activate drug SnET2, a proposed drug and light treatment for patients with wet AMD. The ophthalmic PDT laser was co-developed by Miravant and Iridex Corp, a leading manufacturer of semiconductor-based diode lasers, and was tested with drug SnET2 in two independent phase III clinical trials.

Alimera Sciences debuts. Alimera Sciences, created in 2003 by former Novartis Ophthalmics executives, has received $26.75 million in financing for acquisitions and continued development of the company's ophthalmic pharmaceutical pipeline. Alimera intends to launch a line of over-the-counter eyecare products, the first of which will be a treatment for dry eye.

Climb Mount Kilimanjaro. Volunteers are invited to join the fifth annual "hike of a lifetime" to the top of Kilimanjaro in Africa, plus a 3-day safari. The trip is scheduled from Jan. 29 to Feb. 9, 2005. Proceeds go to fund sight-restoring surgery for Guatemalan children. The hike proceeds over a non-technical route, so no ropes are used and no climbing experience is needed. For further information, call (386) 734-1783 or log on to www.voshpa.org.

Kelman tribute scheduled. Charles M. Kelman, M.D., who revolutionized cataract surgery with his invention of phacoemulsification in the late 1960s, will be remembered by his colleagues, friends and family at a tribute on Monday, Sept. 13, at 11:30 a.m. at the St. James Theatre, 44th Street between Broadway and 8th Avenue in New York City. All are welcome to attend. For more information, contact Diane Spiro at (212) 736-9696, or e-mail DianeS2020@aol.com.

Sear to Retire as Alcon CEO
Cary Rayment Set to Head Company in October.

Alcon Chairman, President and CEO Tim Sear, 67, will retire as president and CEO of the company effective Oct. 1. Sear will serve as a member and chairman of the Alcon board of directors until next May.

During Sear's tenure, Alcon became a publicly traded company, increased overall sales to almost $4 billion annually, and was consistently named as "One of the Best 100 Companies to Work For" by Fortune magazine.

Tim Sear

In a special meeting held on July 12, Alcon's board elected Cary Rayment, currently senior vice president, Alcon United States, to fill the president and CEO positions. In addition to his current U.S. role, Rayment is also responsible for Alcon's global marketing and its operations in Japan.

"I've had a long and exciting career at Alcon for the past 34 years," said Sear. "Alcon has grown more than a hundredfold over these years and is active in virtually every country worldwide. It is now time for me to spend more time with my family and to pursue other personal interests. Alcon is a remarkable company, with a broad and deep management team. I have the utmost confidence that Cary will provide skilled and dynamic leadership for the outstanding people of Alcon, who are our greatest asset."

Rayment, 57, joined Alcon in 1989, following the acquisition of CooperVision Surgical, as vice president, Surgical Products Marketing. Since then, his responsibilities have steadily increased. He previously served as vice president and general manager for Surgical Products, Managed Care, International Marketing and Alcon Japan before moving to his current position in January 2001.

"I'm delighted to have the opportunity to lead Alcon and our 12,000 people into the future," said Rayment. "Alcon has experienced considerable growth under Tim's leadership, and I'm looking forward to building on the sound foundation we have created over the years."

Kevin Buehler, 47, currently vice president, Latin America, Canada and Far East, will be promoted to senior vice president, Alcon United States, replacing Rayment. He has been with Alcon for 20 years in a variety of positions of increasing responsibility.

Study: Kids Given Glasses They Don't Need
Researchers Find Optometrists Most Likely to Err.

Vanderbilt University researchers who studied the records of thousands of preschoolers tested through Tennessee's statewide screening program -- and then referred for follow-up eye exams -- found that many children with no eye problems were still prescribed eyeglasses.

The Journal of the American Association of Pediatric Ophthalmology and Strabismus reports that following the initial screening of more than 100,000 children, 3,640 were referred to specialists for follow-up because of suspected disorders such as amblyopia. The specialists found that 890 of these children had normal vision and no amblyogenic factors, yet 174 of the children had already been prescribed eyeglasses in the initial examination. In every case, the eyeglasses had been prescribed for minor refractive errors that didn't meet the American Academy of Ophthalmology' standards for prescribing glasses for young children.

Of the 890 children in the referred group with no eye problems, optometrists initially misdiagnosed 145 of 413 children, while general ophthalmologists misdiagnosed 24 of 205. Pediatric ophthalmologists had the best record in making accurate initial diagnoses, with only five of 272 misdiagnosed.

The study's author, Sean Donahue, M.D., Ph.D., associate professor of ophthalmology, pediatrics and neurology at the Vanderbilt University School of Medicine, suggests that optometrists and ophthalmologists who usually treat adults may not have enough experience with correctly assessing the vision of young children. Younger children are often a bit hyperopic, but this condition is usually self-correcting and doesn't require glasses, the researchers said.

REFRACTIVE SURGERY UPDATE

LADARVision treatment range. The FDA has approved an expansion of the treatment range for Alcon's CustomCornea wavefront-guided LASIK procedure. Performed with the LADARVision System, CustomCornea is now approved for treatment of myopia up to -8.0D (up from -7.0D) and astigmatism up to -4.0D (up from -0.5D).

This approval gives Alcon the broadest wavefront-guided treatment range of any refractive laser system in the United States. Alcon says eye surgeons can now use the LADARVision System to treat more than 90% of all myopic LASIK patients with the customized procedure.

Further clinical trials are ongoing to demonstrate the effectiveness of the LADARVision System for wavefront-guided treatment of hyperopia with and without astigmatism, and for the treatment of eyes with other symptoms, such as pre-existing night vision problems and post-LASIK complications.

Nidek eye tracker approved. The FDA has approved Nidek's advanced 200 Hz eye tracker for use with the company's EC-5000 Excimer Laser System. The EC-5000 is approved in the United States for LASIK and PRK for myopia with or without astigmatism. The advanced infrared eye tracker, which has been in use internationally for several years, is also a key element in the development of Nidek's NAVEX customized ablation platform. The NAVEX platform has yet to be approved for use in the United States.

WaveLight milestone in China. WaveLight Laser Technologie AG said it recently sold its 100th Allegretto Wave excimer laser for refractive surgery in China. WaveLight's sales partner in China is Lumenis APAC.

"The Chinese market for medical lasers, in particular, offers enormous future growth opportunities," said Max Reindl, WaveLight's CEO.