Industry strong at this year’s AAO

Launches, re-launches and roll-outs highlighted a good year for industry at the annual meeting.

[Editor’s note: Due to an oversight, this article includes several paragraphs from an uncorrected draft. As the passages concerning CIBA Vision contained errors of fact, that portion of the article is being reprinted in the December 15 issue article "News from AAO not just about hottest refractive technologies" in its correct form. Ocular Surgery News regrets any confusion caused by this error.]

DALLAS — As noted in our page 1 story on clinical news from the American Academy of Ophthalmology (AAO) meeting, the mood in ophthalmology this year is one of optimism. This is especially true in industry. Reporters at this year’s meeting heard that sales are strong; that exciting new technologies are being launched, with more following behind them through the regulatory pipeline; that mergers, restructurings and acquisitions are bringing important changes to some of the large ophthalmic companies. Here is a rundown of business news from the meeting.

From CIBA to Novartis

In addition to putting new branded products on the market, the company formerly known as CIBA Vision Ophthalmics is undergoing a modest re-branding itself.

Buying Wesley Jessen last summer made CIBA Vision one of the world’s biggest contact lens companies. In July, Novartis announced a corporate restructuring that created CIBA Vision as a “vision correction business” standing alongside the other major units of pharmaceuticals, generics, and consumer health. The new “ophthalmics” unit within the Novartis specialty pharmaceuticals division will handle the eye drops — established brands like Voltaren as well as new launches like Visudyne and Rescula.

Luzi von Bidder, head of the ophthalmics business unit of Novartis, explains what it all means.

“We are now in the transition from CIBA Vision Ophthalmics to Novartis Ophthalmics,” Mr. von Bidder told Ocular Surgery News. “We are changing the name of the business, but not the people on the team. That will give us more access to compounds in research and also to research funding.”

Some of that research started far away from the eye. Ophthalmologists might not have heard of Sandostatin LAR, but it looks like the next “crossover” drug to create a new treatment for a difficult retinal disease.

This slow-release form of octreotide has entered phase 3 clinical trials for the prevention of diabetic retinopathy. The drug is administered not to the eye, but as a monthly intramuscular injection.

“Sandostatin LAR comes out of the oncology group, the customers are endocrinologists or general practitioners treating diabetics, and the monitoring physician is an ophthalmologist,” Mr. von Bidder said. “That’s a clear case where we have to be smart in putting all this together, or many patients will never get this therapy. That’s one example encouraging us to move closer to pharma and become a business unit in that sector.”

But Mr. von Bidder wants to emphasize the continuities that the physician can rely on.

“CIBA Vision as you have known it — contact lenses, lens care and surgical products — continues,” he said. “The ophthalmics group will continue with the same people and the same structure, just moving closer to the pharma side to get even more commitment to push forward in ophthalmology.

“We have already had great success launching Visudyne. We have filed for additional indications and I am optimistic about that since we got priority review. I think the data are very strong, so we should be extending the franchise of Visudyne soon. We have officially launched Rescula [unoprostone] in the U.S. at this Academy. It is the first docosanoid approved in the United States, also under priority review, and is now available throughout the U.S. market.”

News from CIBA Vision

On the vision correction side of the business, CIBA Vision announced the reintroduction of the MemoryLens to the U.S. market following its September return in Europe.

Trace remnants of polishing compounds on some lenses led to inflammatory reactions in about one in 1,000 patients who received the lens, according to CIBA Vision, prompting the company to withdraw the lens from the market. Since then, the manufacturing processes for the MemoryLens have been modified in order to eliminate the problem.

“There have been some misleading reports that there was a problem with the lens material,” CIBA Vision surgical business unit president David Bailey told Ocular Surgery News. “That is just not true. This is a very biocompatible material that has a long record of success.”

Patients who receive the newly manufactured MemoryLens will be enrolled in a study to verify that the lens is again giving satisfactory results.

“Under the direction of the FDA, we will be closely following the first 100 cases,” Mr. Bailey said. “We will also be conducting a telephone follow-up of 1,000 patients who had previously received the MemoryLens. We are happy to do this to assure the surgeons who use our lens that it is safe.”

The next step for the MemoryLens will be the introduction of a new model that comes pre-rolled more tightly for smaller-incision implantation. In order to avoid unnecessary delay in reintroducing the lens, however, the company decided to bring the standard-roll model back before launching the tight-roll version.

Phakic IOL possibilities

CIBA Vision also announced at the AAO that it has acquired the three patents from Georges Baikoff, MD, for foldable phakic anterior chamber intraocular lens designs to correct not only myopia and hyperopia but also presbyopia.

“We are very excited about this new technology,” Mr. Bailey said. “We think that the MemoryLens material combined with these anterior chamber designs will be a very successful combination.”

That anterior chamber lens initiative complements another refractive implant that was the subject of several presentations in the CIBA booth — the PRL. This posterior chamber phakic implant is being developed by Medennium Inc. CIBA Vision took a 10% equity stake in Medennium in July and now holds exclusive worldwide marketing and distribution rights to the lens, which is currently in phase 2 clinical trials.

Santen shows Quixin

Although their allergy drop Alamast (pemirolast potassium) was approved for marketing first, the U.S. subsidiary of Japanese ophthalmic giant Santen was clearly putting its weight behind the launch of Quixin at the AAO.

Quixin (levofloxacin 0.5%) is the L-isomer of ofloxacin, so much of the information about the drug was stated in comparison to its fluoroquinolone cousin Ocuflox (ofloxacin 0.3%, Allergan).

In a press conference held during the AAO meeting, Santen Inc. senior vice president for worldwide clinical development Adrienne Graves, PhD, referred to levofloxacin as “the more active isomer of ofloxacin.” The molecule is 10 times more soluble, she continued, “so it can be formulated for clinical use at 0.5% rather than 0.3%. In vitro testing also showed that some ofloxacin-resistant organisms were susceptible to levofloxacin.” The new fluoroquinolone also has a very good safety profile, Dr. Graves pointed out. As one of the clinical investigators reported later, clinical trials have found no greater adverse event incidence with levofloxacin (or ofloxacin) than with placebo.

Santen had just begun shipping Quixin to wholesale and retail pharmaceutical vendors as the AAO meeting began. The company obviously hopes to capture its share of the fluoroquinolone market, the richest segment of the total $150 million U.S. ophthalmic anti-infectives market.

But with Alamast on line and U.S. rights to Betimol (timolol hemihydrate) reverting back from CIBA Vision, Santen will soon have brands in three major product categories. Corporate headquarters is clearly expecting a significant contribution from the U.S. to boost its global revenues above the most recently reported annual figure of $660 million.

Next from Allergan

Clinical investigators reported on phase 3 trials of AGN 192024, the proprietary compound that will presumably be marketed by Allergan as Lumigan following FDA approval. The new drug application was filed in September, according to the company, and has been accepted for a 6-month priority review by the FDA. Clinical study data were presented in a scientific symposium on the AAO program and in an off-site press conference.

James Brandt, MD, associate professor of ophthalmology and director of the glaucoma service at the University of California, Davis, said that in a trial comparing once- versus twice-daily dosing with Lumigan versus timolol twice a day, the once-a-day Lumigan regimen proved superior in reducing intraocular pressure and minimizing adverse effects.

“This is about as good a story for going right to first-line therapy as anything we’ve seen,” Dr. Brandt told reporters.

Other “pipeline” news was of the good and not-so-good varieties.

The week following the AAO meeting, Allergan and Acadia pharmaceuticals announced the filing of an investigational new drug application for AGN 195795. Acadia and Allergan have been partners in drug development since September 1997, and this new alpha adrenergic compound is a result of that “functional genomics collaboration.”

In a third-quarter earnings report issued on the eve of the Academy meeting, Allergan announced the return of its cyclosporine A formulation for dry eye (Restasis) to further study. According to a company press release, “Allergan has started to work rapidly to initiate this trial,” which was described as “one additional confirmatory study.”

Visx rolls out ActiveTrak

The Star S3 ActiveTrak laser with variable spot scanning was announced earlier this year at the American Society for Cataract and Refractive Surgery meeting, but at an AAO press conference it was announced that full production and roll-out of the laser has now begun. According to Visx president and chief operating officer Liz Dávila, Visx is also in the process of upgrading all the S2 systems. She added that the Food and Drug Administration just approved the use of the Star Excimer Laser System for treating hyperopic astigmatism.

Ms. Dávila also announced a research collaboration between Visx and Stanford University to develop treatments for age-related macular degeneration. “We’ve been looking for exciting opportunities that we thought would be truly breakthrough technologies in the field of ophthalmology,” said Ms. Davila. “This one absolutely goes to the top of the list in terms of potentially meeting a need that nothing else has met.”

Led by Mark Blumenkranz, MD, a team of scientists in the areas of medicine, ophthalmology, neurobiology, computer science, electronic engineering and applied physics will focus on the areas of tissue engineering, cell transplantation and electronic visual prosthesis development. “We’re just delighted to have come upon an opportunity like this and to have exclusive marketing rights to the products that might result from this,” Ms. Dávila added.

Pharmacia gives back

Pharmacia has seen a host of approvals occur this year and is awaiting several others it hopes soon will be announced by the FDA. Xalatan (latanoprost), approved only a few years ago, has proved to be Pharmacia’s third highest selling drug, and the number one glaucoma medication in the world, with sales of $185 million. Pharmacia announced the issuance of a second approvable letter from the FDA Oct. 20 of the company’s Xalcom glaucoma drug, which combines Xalatan with timolol.

Other Pharmacia products waiting for final approval to be released out of the regulatory pipeline include the viscoelastic Healon-5 and the CeeOn Edge IOL.

Another of Pharmacia’s ophthalmology pipeline products expected to be approved in the near future is the drug SnET2 for AMD. SnET2 is in phase 3 trials for photodynamic therapy of subfoveal choroidal neovascularization. There is no firm date when SnET2 will finish phase 3 trials; however, results of the 1-year patient data is expected to be available in the first half of 2001.

Pharmacia is donating some of the money it has taken in from its glaucoma drugs to fund glaucoma prevention. During the AAO meeting the company presented a $1.5 million check to the Foundation of the AAO to help fight preventable blindness due to glaucoma. Pharmacia is a co-sponsor of the AAO Foundation’s EyeCare America — Glaucoma Project.

B&L self tonometer

Bausch & Lomb is launching a new tonometer for use by patients in the home, by eye care practitioners in emergency rooms and operating rooms, by family physicians and by non-ophthalmic technicians in outreach clinics. The results achieved by the ProView eye pressure monitor, which was developed by a Canadian optometrist, have been shown to correlate well to those achieved by Goldmann tonometry. Bernard B. Fresco, MSc, OD, first introduced the device as the Fresco phosphene tonometer at the Association for Research in Vision and Ophthalmology meeting in 1997.

The ProView tonometer is a spring compression device with a probe the same diameter as the Goldmann tonometer. The device is applied to the superior nasal portion of the closed eyelid without anesthetic. The patient looks down and out. Pressure is gently applied, and when the patient perceives the pressure phosphene, the probe is removed and the reading is taken. In a study of 192 eyes, the mean difference between the ProView tonometer and the Goldmann was 0.3 mm Hg.

According to Bausch & Lomb, the product will be available to doctors’ offices and drug stores in March 2001.