at press time

Investors Snap Up Eyetech Stock Shares
Attention Centers on Company's New AMD Treatment.

On Jan. 30, 6.5 million shares of Eyetech Pharmaceuticals were offered to the public at an initial price of $21 a share. By the end of the trading session, the price had jumped to $32.40 a share, a gain of more than 50% in a single day.

The sharp rise in Eyetech (NASDAQ symbol EYET) represented one of the most impressive debuts by a biotech company in recent years. It was reminiscent of the heady days of the late 1990s, when new biotech stock offerings would double or triple on their first day of trading.

In a large phase III study of Macugen, 33% of the patients with various forms of wet AMD who were given Macugen intravitreally every 6 weeks showed stabilized or improved vision after 54 weeks. Though one or more of several potentially competing drugs currently being developed by other companies may eventually prove to be a more effective treatment for wet AMD, Macugen is the furthest along in the approval process for this indication. Eyetech is expected to file with the FDA later this year for marketing approval of Macugen for various forms of wet AMD. The company is also currently conducting a Phase II study using Macugen to treat DME.

Investors also like the fact that Eyetech has a strong partner in Pfizer, based on an agreement the two companies entered into in December 2002. Pfizer, which will co-promote Macugen in the United States, has already paid Eyetech $100 million and could be obligated for up to $450 million in milestone payments to Eyetech if Macugen proves to be a commercial success. Thus far, Eyetech has accumulated losses of $123.8 million since it began operations in 2000.

Sena Lund, an analyst with Cathay Financial in New York City, said Macugen has the potential to achieve "blockbuster" status because the only currently approved treatment for wet AMD is verteporfin for injection (Visudyne), which is only able to slow the progression of the disease.

The 6.5 million shares sold to new investors represents less than 20% of the total shares of Eyetech. With more than 38 million shares of Eyetech outstanding, the company was valued by the market at more than $1.2 billion after its first day of trading.

Visudyne Gets Expanded Coverage
CMS Will Reimburse for Occult and Minimally Classic AMD.

QLT Inc. and Novartis Ophthalmics, the co-developers of verteporfin for injection (Visudyne), have announced that the Centers for Medicare and Medicaid Services (CMS) has approved reimbursement of Visudyne treatment of AMD patients with occult and minimally classic lesions that are four disc areas or less in size and that show evidence of recent disease progression.

CMS, which had previously refused to approve payment for the use of Visudyne in treating the occult and minimally classic forms of AMD, says the evidence now supports reimbursement.

Medicare already offers coverage for Visudyne treatment of AMD patients with predominantly classic lesions.

"This is a significant event for the many people who suffer from the occult and minimally classic forms of AMD who presently have no treatment options available to them," said Paul Hastings, president and CEO of QLT Inc.

"Expanded coverage represents a huge step forward in providing Visudyne therapy for many more patients," added Jason Slakter, M.D., a partner in Vitreous-Retina-Macula Consultants of New York and clinical professor of ophthalmology at the New York University School of Medicine. "About 80% of all wet AMD patients have the occult or minimally classic form of the disease. And based on previous studies, about half of that 80% have lesions of the size that will qualify for reimbursement. Many of these patients have wanted to have Visudyne therapy but couldn't do it because they would have had to pay out of their own pockets. Now, they'll be able have the treatments."

Dr. Slakter said he expects the expanded reimbursement for Visudyne to provide a small financial benefit to high-volume retinal practices already set up to use Visudyne in a cost-effective manner.

In a related development, QLT Inc. said it will temporarily lower the price of Visudyne to ophthalmologists from $1,350 per unit to $1,295. The decision was made in response to Medicare's reduction of reimbursement for Visudyne and other physician-administered drugs to 85% of the April 1, 2003 average wholesale price (AWP). Visudyne had previously been reimbursed at 95% of the AWP.

FDA Panel OKs Second Phakic IOL
Limited Use Is Recommended in 7-6 Vote.

By a narrow margin, the FDA Ophthalmic Devices Panel has recommended limited approval of a second phakic IOL -- the Artisan lens. The lens, developed by Ophtec and marketed in Europe as the Artisan, would, if approved, be marketed in the United States by Advanced Medical Optics (AMO) and known here as the Verisyse.

The Artisan (Verisyse) phakic IOL

Last fall, the Ophthalmic Devices Panel recommended FDA approval of STAAR Surgical's Implantable Contact Lens (ICL) by an 8-3 vote. However, STAAR was recently cited for deviations from federal quality regulations. Though the violations don't directly involve the ICL, the ICL can't receive final approval until STAAR resolves these issues with the FDA.

The panel was cautious in approving both the ICL and the Artisan. In the case of the ICL, the panel expressed concern over the potential for endothelial cell loss and recommended that patients have endothelial cell counts before surgery, and also during a multi-year follow-up period. With the Artisan, which is attached to the periphery of the iris, the panel recommended that patients have an anterior chamber depth of more than 3.2 mm and myopia of -9D or greater. The panel also called for a post-market study. Some panel members suggested that the lens initially be used in patients age 30 and older.

Though the FDA usually concurs with panel recommendations, companies can hold discussions with the FDA before the conditions for final approval are announced. AMO said it would negotiate with the FDA in an attempt to convince the agency to allow a wider range of eligible patients.

IN THE NEWS

Combination glaucoma drug. Alcon said the FDA has accepted its New Drug Application for a glaucoma treatment called Travoprost 0.004% and Timolol 0.5% Fixed Combination (TTFC). The company said Phase III studies demonstrated that TTFC is able to achieve the same IOP reduction as travoprost 0.004% and timolol 0.5% taken separately.

"We hear regularly from physicians that they would welcome a combination product like this to reduce the frequency of the dosing schedule and to potentially improve compliance with the therapeutic regimen they prescribe," said Stella Robertson, Ph.D., vice president of Pharmaceutical Products R&D at Alcon.

Drug-delivery partnership. SurModics. Inc., a leading developer of coatings for stents and other medical devices, will invest up to $3.5 million in InnoRx, an Alabama-based drug-delivery company developing new applications to treat retinal diseases. InnoRx was founded by Eugene de Juan, M.D., one of the world's leading retinal specialists.

In collaboration with SurModics, InnoRx is developing a patented, implantable coil to deliver timed-release therapeutic agents in the eye to treat various retinal diseases, including AMD and diabetic retinopathy. This product utilizes SurModics' site-specific drug-delivery technology.

InnoRx plans to begin animal studies in the first half of this year, and human clinical trials later in the year.

Lumigan upgraded in Europe. The European Commission has approved bimatoprost ophthalmic solution 0.03% (Lumigan) as a first-line therapy for the reduction of elevated IOP in chronic open-angle glaucoma and ocular hypertension. Prior to this change, Lumigan was indicated for patients who were insufficiently responsive, intolerant or contraindicated to first-line therapy.

OWL panel discussion. Ophthalmic Women Leaders (OWL) will present a panel discussion and Q and A with several ophthalmic industry CEOs during the ASCRS meeting.

The event, called Follow the Leaders, will be held Sunday, May 2 from 5 to 7 p.m. at the Marriott Hotel in San Diego.

Panelists are expected to include Liz Davila, chairman and CEO of VISX; Adrienne Graves, Ph.D., CEO of Santen, Inc.; James V. Mazzo, president and CEO of Advanced Medical Optics; and Michelle Glossip, CEO of Duckworth & Kent. Marguerite B. McDonald, M.D., of the Southern Vision Institute, will serve as the panel moderator.

For further information, please e-mail owlbox@cox.net.

Clinical trial enrollment. Genentech is currently enrolling patients into a Phase III clinical trial for its new treatment for wet AMD, Lucentis. Called ANCHOR, the trial is a randomized, multi-center, double-masked, active treatment-controlled study comparing two different doses of Lucentis to Visudyne in approximately 425 patients with predominantly classic wet AMD. For more information on enrolling your patients, call (888) 662-6728.

REFRACTIVE SURGERY UPDATE

Panel recommends CK for presbyopia. The FDA's Ophthalmic Devices Panel in February voted unanimously to recommend approval of Refractec's Conductive Keratoplasty (CK) procedure for treating emmetropic and hyperopic presbyopia from +1D to +2.25D. The FDA usually follows the recommendations of the panel.

The minimally invasive CK procedure takes about 3 minutes and uses radio waves to restore patients' near vision without impacting their distance vision. Refractec says the procedure has one of the highest safety profiles in the refractive market.

The company's Viewpoint CK System is the first product ever reviewed by the FDA specifically for presbyopic patients who want to improve their near vision. The CK procedure was approved in 2002 for the treatment of moderate hyperopia in patients over 40 and has already captured significant market share in its approved range.

The panel's recommendation to approve CK for presbyopia was based on clinical 12-month follow-up data in a study involving 150 patients.

In this study, 94% of patients could see J5 (magazine- and newspaper-size print) in the eye that was treated, while 83% of patients could see 20/20 and read J3 (smaller phonebook-size print) in the treated eye. There were no reported serious, sight-threatening or unanticipated safety events. However, the panel noted that the improvement provided by the procedure might prove to be temporary.

CORRECTIONS

The January 2004 Instrument Insider column incorrectly stated that a new CPT code covers in-office partial pars plana vitrectomy. The 2004 edition of CPT doesn't contain a new code to describe this procedure, but two existing CPT codes are applicable: 67015 (aspiration or release of vitreous, subretinal or choroidal fluid, pars plana approach, posterior sclerectomy) and 67036 (vitrectomy, mechanical, pars plana approach). The selection of an appropriate CPT code will depend on the purpose and extent of the surgery as documented in the operative report.

For further information, check the policies of your local Medicare carrier and third-party payers.

On page 52 of the February article Accommodative IOL Finding Its Niche, an incorrect number was printed. The article should have stated that in bilateral cases performed during the FDA trials of the Crystalens, to avoid hyperopic error in the first eye and enhance binocular vision at intermediate and near after second-eye implantation, investigators aimed for a -0.50D correction in the first operative eye.

CIBA Vision Sells Surgical Businesses
IOLTECH Purchases Several Product Lines.

CIBA Vision Corporation, the eyecare unit of Novartis AG, said it has completed the sale of a significant portion of its surgical business. The company had announced last August that it was studying strategic alternatives for its surgical business, including a possible sale, because the business was just not big enough to become a major contributor to profits.

The Ex-Press mini-shunt.

A number of CIBA Vision product lines have been purchased by IOLTECH, SA. These include the Vivarte phakic IOL, the Vivarte Presbyopic phakic refractive lens, and the CV232 SRE IOL. Also acquired by IOLTECH are Tear Saver and Tear Saver Plus punctum plugs, UniVisc viscoelastic, VisThesia, a viscoelastic that includes anesthesia, and Ophthalin and Ophthalin Plus viscolelastics. IOLTECH has also purchased certain marketing and distribution rights to the PRL phakic IOL.

In another transaction, Optonol Ltd. and CIBA Vision have agreed on a mutual release of contract for the Ex-Press Mini Glaucoma Shunt. Optonol, which has been distributing the Ex-Press throughout the European Union, will now assume distribution of the product in the United States and Canada.

Negotiations for the remaining products within CIBA Vision's surgical portfolio are continuing.

"We did not have the scale or necessary presence in the market to fully capitalize on the surgical portfolio, and this will allow us to focus on our core lens and lens care businesses," said Joe Mallof, CIBA Vision CEO.

"We are confident that the promise of the products and technologies in the surgical portfolio will be better realized by the new owners. Our commitment to our customers is that we will ensure a smooth transition," Mallof added.

CIBA Vision said it will provide transitional services on a case-by-case basis to the new owners to minimize the effects on customers and their patients. 

Communicate with Glaucoma Patients
Use These Tips to Help Them Better Understand the Disease.

A recently released survey of more than 4,300 glaucoma patients conducted by the Glaucoma Research Foundation,  with an unrestricted grant from Allergan, reveals a glaring "communications gap" between many glaucoma patients and their doctors.

The results of the survey included the following findings:

• Forty percent of the glaucoma patients surveyed didn't know that the disease can lead to blindness.
• More than half of the patients didn't understand the importance of lowering IOP.
• Ten percent of the respondents felt that they don't get enough information from their doctors.
• Sixty percent of patients who had switched physicians cited poor communication as their reason.

To close the communications gap between ophthalmologist and patient, Edith Marks, author of Coping with Glaucoma, offered these suggestions at the American Academy of Ophthalmology meeting in November.

• Discuss the possible side effects of medications. Patients experiencing side effects often panic, and some explanation from you will help them adjust.
• Instruct patients on the proper installation of the eye drop, including information on the importance of punctal occlusion.
• Help patients adjust to reduced vision, including legal blindness, by referring them to services available in the community.
• Keep the gloom and doom out of the dialogue with the patients. Patients given a depressing prognosis will often stop trying to help themselves.

Richard Laermer, CEO of RLM Public Relations, adds that ophthalmologists should give glaucoma patients ways to access information about the disease and to ask questions. He suggests that patients be provided with the "800" number (800-826-6693) and Web site address (www.glaucoma.org) of the Glaucoma Research Foundation. He also suggests setting up a special e-mail address to which patients can send questions or comments -- and receive answers.