at press time

AAO Fights Oklahoma OK of O.D. Surgery
New Law Gives Wide Latitude to Optometry.

"This new law essentially converts optometrists into ophthalmologists," said H. Dunbar Hoskins Jr., M.D., executive vice president of the American Academy of Ophthalmology (AAO). "Moreover, it raises serious patient safety and quality of care issues."

"What's going on in Oklahoma threatens patient care everywhere and cannot go unchallenged," added Allan Jensen, M.D., AAO president. "Legislating surgical privileges in Oklahoma will surely feed optometry's hunger for these same privileges in other states."

Oklahoma has been in the forefront of the scope of practice battle between ophthalmology and optometry. It's the only state in which optometrists can be licensed to perform any laser eye surgical procedure.

The AAO is particularly outraged that when Oklahoma optometry interests presented their case for an expanded scope of practice to the state legislature, they argued that optometrist attendance at AAO-sponsored educational seminars had helped prepare O.D.s to perform surgical procedures.

"We find this argument ridiculous on its face," said Sandra Remey, communications manager for the AAO's Division of Governmental Affairs.

The AAO has now barred optometrists from attending all Academy educational activities, noting in a statement that its programs are developed for ophthalmologists who possess the educational foundation of medical school, internship and residency.

"Without this base of knowledge and experience, the information cannot be fully optimized for its intended patient benefit," the AAO statement continued. "Unfortunately, optometrists have attended Academy courses in the past and used their participation as justification to perform procedures that are beyond their education, training or experience. Such a misrepresentation of qualifications runs counter to the accountability the American public and its watchdogs demand and deserve."

The AAO said it's already receiving support from the wider medical community in its fight to roll back the new Oklahoma legislation, and Gov. Henry has indicated that the medical and osteopathic communities will have some input into determining the scope of practice for state O.D.s. But despite his assurances, the new legislation makes the pro-optometry Oklahoma Board of Examiners in Optometry the rule-making body in deciding the parameters of O.D. scope of practice.

IN THE NEWS

StabilEyes CTR approved. The FDA has approved the StabilEyes capsular tension ring (CTR) for use in cataract surgery in the United States. The StabilEyes CTR was developed by Ophtec and will be marketed throughout North America by Advanced Medical Optics (AMO).

"Capsular tension rings like StabilEyes offer the surgeon a new level of safety for complicated cataract cases," said Russ Trenary, AMO's chief marketing officer. "By stabilizing the capsular bag with StabilEyes, surgeons will have the ability to easily perform successful posterior chamber IOL implantation when the integrity of the capsular bag is, or could become, compromised."

The StabilEyes is the second CTR to receive FDA approval. The Morcher CTR was approved by the FDA last year.

Generic ofloxacin approved. Both Bausch & Lomb and Falcon Pharmaceuticals, an affiliate of Alcon, have received FDA approval to market generic ofloxacin ophthalmic solution USP, 0.3%, an anti-infective that's therapeutically equivalent to Ocuflox. The new generic is indicated for treating infections caused by susceptible strains of bacteria in both conjunctivitis and corneal ulcer conditions. The drug is available in 5 and 10mL sizes from both companies.

Pfizer partners with ARVO. Pfizer Ophthalmics has made a $500,000 grant to the Association for Research in Vision and Ophthalmology (ARVO) to promote advanced research related to preventable blindness, with a focus on glaucoma and diseases of the retina. The unrestricted grant will be used by ARVO to fund a series of annual interdisciplinary research conferences, and also for awards that recognize research leading directly to new treatments and cures.

Vitrase Approved as Spreading Agent
The Drug Is a Replacement for Discontinued Wydase.

ISTA Pharmaceuticals has received FDA approval to market lyophilized ovine hyaluronidase for injection (Vitrase) for use as a spreading agent for injectable anesthesia in ophthalmic surgery. The approval is considered highly significant because no commercial spreading agent has been available to surgeons since Wyeth-Ayerst Labs discontinued production of its Wydase product in 2001.

"We believe that Vitrase represents an improvement over Wydase because it's derived from sheep, which avoids disease transmission concerns that arise periodically regarding bovine tissue," says Tom Mitro, vice president of sales and marketing for ISTA. "Another advantage of Vitrase over Wydase is that it's preservative-free, whereas Wydase contained thimerosal."

For reasons having to do with ISTA's original drug development model, the initial approval covers only a Vitrase vial that contains 6,200 units in wafer form that must be reconstituted. ISTA intends to distribute these vials to surgeons only as samples later in the year.

However, the company believes that, pending submission of a supplemental New Drug Application and FDA review, a single-dose vial of 150 units could be approved before year's end, opening the door for full-scale commercialization.

When Wydase was discontinued, it literally sent shock waves through the ophthalmic community. This was because the drug had been so widely used in cataract surgery and other intraocular procedures. The American Academy of Ophthalmology (AAO) estimated that Wydase had been used in approximately 750,000 ophthalmic surgical procedures in 1999.

The AAO considered the withdrawal of Wydase from the marketplace so important that it formed a task force to evaluate the use of Wydase and the impact of its disappearance. The panel cited reports that the absence of hyaluronidase produced longer anesthetic dissemination time, greater orbital swelling, and even strabismus. The task force was unanimous in asserting that injectable anesthetics, while important for globe fixation and patient comfort, couldn't be administered as safely and effectively without Wydase.

After the discontinuation of Wydase, surgeons stretched their remaining supplies of the drug by reducing the concentration used in each procedure, or turned to compounding pharmacies. Many surgeons began to rely on topical anesthesia and/or sub-Tenon's blocks.

AMO to Acquire Pfizer's Surgical Lines
Purchase Will Expand AMO's Presence in Key Areas.

Advanced Medical Optics (AMO) has entered into a definitive agreement to acquire Pfizer's surgical ophthalmology business for $450 million in cash. The acquisition is expected to increase AMO's annual sales by about 25% and be immediately accretive to earnings.

Among the products AMO will acquire is the Healon line of viscoelastic products used in ocular surgery, CeeOn and Tecnis IOLs used in cataract surgery, and the Baerveldt glaucoma shunt. These products accounted for about $150 million in sales in 2003. AMO will also acquire manufacturing and R&D facilities in Groningen, Netherlands; Uppsala, Sweden; and Bangalore, India.

"The acquisition represents an ideal strategic fit for AMO," said James V. Mazzo, AMO president and CEO. "It will expand our revenue base and enhance our cash flow and profitability. The highly regarded Healon brand is the original and most recognized viscoelastic brand, and the Healon family of products offers surgeons a wide range of functionality. Pfizer's excellent work in optical design and surfaces has also yielded superb IOL technologies, including the Tecnis, which improves functional vision, and the Tecnis multifocal, a promising diffractive lens with great potential for refractive applications."

AMO is buying the Healon brand.

Mazzo said all the assets involved in the acquisition complement AMO's proficiency in advanced phacoemulsification, acrylic and silicone IOL design, IOL insertion systems and other IOL technologies.

IN THE NEWS

Macugen DME study. Eyetech Pharmaceuticals and Pfizer Inc. report that a Phase II trial of the investigational drug Macugen produced positive visual and anatomical outcomes in patients with diabetic macular edema (DME). For example, at 36 weeks, 34% of the patients who received intravitreal injections of Macugen gained 2 or more lines compared with 10% of the patients who received injections of a placebo. In addition, the Macugen-treated patients overall demonstrated far greater reductions in retinal thickness than the control group.

Macugen has already completed a successful Phase III trial for the treatment of wet AMD and a New Drug Application for Macugen is expected to be submitted to the FDA later this year.

Retinal detachment treatment. Inspire Pharmaceuticals has begun a Phase II clinical trial for denufosol tetrasodium (INS37217 Ophthalmic) for the treatment of rhegmatogenous retinal detachment (RRD). The company says INS37217 is the first pharmaceutical treatment for RRD, which until now has required surgical intervention.

INS37217 is a P2Y2 receptor agonist that's been shown to stimulate the removal of accumulated fluid in the sub-retinal space. Removal of this fluid is critical for repairing retinal reattachment. INS37217 will be tested on approximately 160 patients in 25 centers across the United States. Patients will be given a single intravitreal injection, followed by up to two additional consecutive daily injections in patients who show signs of improvement following the initial injection.

"The activation of P2Y2 receptors in the back of the eye to remove pathological fluid could potentially provide benefit for patients with RRD, as well as for patients with other sight-threatening diseases that involve fluid accumulation in or around the retina," said Christy L. Shaffer, Ph.D., Inspire's CEO.

Vigamox labeling expanded. Alcon has received FDA approval to add a supplemental list of 22 susceptible pathogens to its Vigamox ophthalmic solution in vitro labeling. Alcon says the addition of these pathogens, which include atypical mycobacteria, will result in Vigamox providing the broadest spectrum of coverage in the ophthalmic fluoroquinolone category.

Heidelberg names COO. Travis Lindsay has joined Heidelberg USA as general manager and chief operating officer. Lindsay, who earned an MBA at Southern Methodist University, was previously global director of marketing for Carl Zeiss Meditec.

ThinOptX lens trial. ThinOptX has been given FDA approval to begin a multicenter, 400-patient clinical study of its UltraChoice 1.0 ultrathin IOL for implantation after cataract surgery. The foldable lens is designed to be injected following microincision phacoemulsification. Patient enrollment will begin in the near future.

Genaera COO resigns. Kenneth Holroyd, M.D., has resigned as chief operating officer for Genaera Corp., whose squalamine treatment for wet AMD recently began Phase II clinical trials. Squalamine is an antiangiogenic agent designed to inhibit the growth of unwanted blood vessels. In a related development, Roger Vogel, M.D., a former Merck executive, has been named Genaera's acting chief medical officer.

Successful trial. ISTA Pharmaceuticals said two Phase III clinical trials of 0.1% bromfenac sodium ophthalmic solution (Xibrom) involving a total of more than 500 patients demonstrated positive, statistically significant results in treating ocular inflammation. Assuming timely FDA review and approval, the company plans to launch Xibrom in the first half of 2005.

Miravant applies for approval. Miravant Medical Technologies has submitted a New Drug Application to the FDA seeking marketing approval of SnET2-PDT as a new treatment for wet AMD. SnET2-PDT uses a light-activated drug designed to selectively destroy abnormal blood vessels and stabilize vision loss.

Miravant's submission is based on clinical data from two randomized, placebo-controlled, parallel group Phase III studies, which followed patients for 2 years.

VA halts O.D. surgery. Department of Veterans Affairs Secretary Anthony Principi has declared a moratorium on all laser surgery performed by optometrists in the VA health system. The action came after strong protests by the American Academy of Ophthalmology (AAO) and veterans' organizations. The AAO is backing the Veterans Eye Treatment Safety Act (H.R. 3672), which would mandate that all eye surgery in VA facilities be performed by ophthalmologists.

Santen Inc. Increases Focus on R&D
J&J Agreement Gives Products New Sales and Marketing Muscle.

In a major initiative to make itself more of a research-driven company, Santen Inc. has outsourced the sales and marketing of its four existing ophthalmic products to Johnson & Johnson Vision Care, Inc. (JJVCI), while preparing to ratchet up its successful drug development program.

	Adrienne Graves, Ph.D.

JJVCI is now licensed to distribute the anti-infectives Iquix and Quixin, the glaucoma drug Betimol, and the ocular allergy treatment Alamast. At Santen's option, JJVCI can be given responsibility for the sales and marketing of any new ophthalmic drugs that Santen develops.

"We have great products, with more in the pipeline, but our sales force was approximately one-fifth the size of what the other companies have," says Adrienne Graves, Ph.D., president and CEO of Santen Inc., the U.S. arm of Japan-based Santen Pharmaceuticals Co., Ltd. "The agreement with Johnson & Johnson allows us to aggressively expand the capabilities of the sales force and broaden the market reach of our drugs."

Dr. Graves noted that J&J was able to absorb almost all of Santen's existing sales personnel.

With sales and marketing being handled by JJVCI, Santen plans to allocate additional resources to its R&D budget, focusing on drug development in the areas of retina, glaucoma and dry eye.

"We've developed four products since Santen Inc. was established in 1995," notes Dr. Graves. "We've proven the company's strength in drug development, particularly in the fast-tracking of two FDA approvals. With increased focus in the area of R&D, we now have every opportunity to develop and bring to market more products in new areas on a commensurate timetable."

Santen recently hired Mark A. Mannebach, Ph.D., for the newly created position of vice president of Regulatory Affairs. He will work to enhance Santen's drug development process and lead the company's regulatory team. Santen has also named Mike Ford as its director of Professional Services. Ford will be responsible for developing and managing Santen's interaction with key ophthalmic opinion leaders, and will orchestrate Santen's presence at major industry events. The company expects to appoint a head of Business Development shortly.

Researchers Find New Uveitis Treatment
Four-Year Study Results in 70% Success Rate.

A preliminary clinical study conducted by researchers at the National Institutes of Health (NIH) found that monthly intravenous infusions of the immune therapy drug daclizumab controlled uveitis and was well-tolerated in seven of 10 patients over a 4-year period. The drug caused far fewer side effects than existing therapies, leading to an improved quality of life for patients with this potentially blinding condition.

Uveitis accounts for an estimated 10 to 15% of blindness in the United States. Although the causes of uveitis vary, researchers say the majority of cases are thought to be autoimmune in nature.

Currently, patients with severe uveitis must take steroids or other drugs that suppress the immune system to control the inflammation. These powerful drugs have been known to cause a number of serious side effects, including kidney dysfunction, glaucoma, osteoporosis, increased blood sugar, elevated blood pressure and weight gain. Because their immune systems are compromised, patients must restrict their contacts with other people to avoid contagious diseases.

Results of the clinical study, published in a recent issue of the Journal of Autoimmunity, indicated that daclizumab blocks IL-2 receptors, thereby preventing T helper cells from attacking and inflaming the eye. The researchers also found that intravenous infusions and injections under the skin were almost equally effective in controlling the disease. They said this might allow patients to administer the drug to themselves at home, making the treatment even more convenient.

REFRACTIVE SURGERY UPDATE

Accommodating IOL. Advanced Medical Optics (AMO) has signed a 1-year research and evaluation licensing agreement with Quest Vision Technologies to develop accommodating IOL designs for correcting presbyopia. Quest is currently developing two designs, the FocusIOL and FlexOptic, for this indication.

"Accommodating IOLs hold great promise as a new vision correction option for millions of presbyopes who now rely on eyeglasses," said James V. Mazzo, AMO president and CEO. Mazzo said the new agreement is consistent with AMO's strategy to complement internal expertise with strategic alliances, acquisitions and other corporate development activities.

Epi-LASIK product line sold. CIBA Vision has sold its Epi-LASIK surgical product line to Norwood Abbey Ltd., an Australian medical devices company. The product line includes the FDA-approved Centurion SES system and EpiEdge epikeratome separator.

CIBA Vision had announced last year that it was considering strategic alternatives for its surgical business, including the potential sale of the unit.

"This is a key step in the sale of our surgical business and allows us to focus fully on our core lens and lens care business," said Robin Terrell, president of CIBA Vision's surgical business. "Epi-LASIK offers an exciting breakthrough in refractive surgery, and the EpiEdge separator plays a key role in making this valuable technology available to ophthalmologists. As a specialized medical devices company, we believe Norwood is well-positioned to realize the value of the Centurion SES EpiEdge epikeratome."

Custom LASIK boosts TLC. TLC Vision said its total revenue for the first 3 months of 2004 were $65.2 million, up 22% from the $53.6 million recorded in the same quarter a year ago. Earnings were 12 cents a share vs. 2 cents in the year-ago period. TLC said higher-priced, higher-margin custom LASIK procedures represented approximately 49% of refractive surgery volumes in its owned and managed centers during the quarter

WaveLight distribution. WaveLight Laser Technologie AG of Erlangen, Germany, said it will assume direct distribution of its ophthalmic products, including the Allegretto Wave excimer laser, in the United States and Europe. Lumenis, which had previously been distributing WaveLight products worldwide, will continue to handle Asian distribution.

Technolas chosen. LASIK Vision Institute, which operates more than 20 laser vision correction facilities in the United States, has chosen the Bausch & Lomb Technolas as its preferred platform for both standard and custom LASIK.