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Issue: March 15, 2000
March 15, 2000
4 min read
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CIBA Vision poised for widescale Visudyne launch upon approval

More than 200 clinical treatment sites have already been set up under the company’s T-IND program.

Issue: March 15, 2000
[SIDEBAR: Alliance targets misinformed]

DULUTH, Ga. — In mid-February, the U.S. Food and Drug Administration (FDA) issued an “approvable” letter for Visudyne (verteporfin for injection, CIBA Vision) therapy for the treatment of predominantly classic subfoveal choroidal neovascularization (CNV). CIBA Vision, located here, is poised to bring Visudyne to market, educate doctors and consumers about the treatment and expand the company’s approved posterior segment products and indications.

Approvable status is the FDA’s acknowledgement that the new drug application (NDA) has been favorably reviewed. This follows a recommendation late last year by the FDA’s Ophthalmic Drug Advisory Panel that Visudyne be approved (see the article “After panel nod, Visudyne launch set for February,” Ocular Surgery News, Dec. 15, 1999, page 1). The drug was approved in Switzerland in December 1999 and is in the approval application process in the European Union, Canada, Norway, Iceland, Australia and New Zealand.

On the starting line

“We’re working closely with the FDA to get approval for Visudyne,” said Stephen H. Lang, executive director of retina sales and marketing for CIBA Vision, North America. “The promising treatment that was once referred to generically as photodynamic therapy (PDT) will soon, we hope, be on the market as Visudyne — a real product that hopefully can help real people keep their vision longer.”

The company has created a special sales and marketing group that will be dedicated to the launch and ongoing support of Visudyne.

“That team is in place right now while we are awaiting final action by the FDA,” Mr. Lang told Ocular Surgery News. “You could say that we’re sitting on the starting line with the engine revved up, just waiting for them to clear the track so we can take off.”

Some advance work by the company should smooth the path for ophthalmologists who want to adopt Visudyne into their clinical practice.

“We expect that Medicare will reimburse physicians for the procedure and Visudyne because, once approved, the therapy fits Medicare coverage requirements. These requirements are that the procedure is performed by a physician and it is medically necessary to treat an injury illness,” Mr. Lang said.

“We have consulted with the AMA [American Medical Association] CPT [Current Procedure Terminology] Editorial Panel about proper coding for PDT with Visudyne. The AMA determined that the code for laser photocoagulation, CPT 67200, should be revised to include ocular PDT. This revision was made for the 2000 CPT code manual.

“As far as billing for Visudyne, physicians will initially have to submit Visudyne with the HCPCS [HCFA (Health Care Financing Administration) Common Procedures Coding System] drug code J3490 (unclassified drug). Of course, we will be working with HCFA to establish a unique HCPCS code for Visudyne as soon as possible,” said Mr. Lang.

Compassionate use

More than 2,600 patients in North America outside the original clinical trials have received Visudyne therapy prior to FDA premarket approval in a special clinical trial set up by CIBA Vision.

“We have a little over 200 Treatment-IND [Investigational New Drug] sites that are currently treating patients on a compassionate-use basis in the interim before FDA approval. This fulfills our goal of getting Visudyne therapy to AMD patients who need it, because there is currently little or no other therapy for this disease.”

The T-IND trial was not part of the trials required by the FDA, Mr. Lang pointed out. CIBA Vision and QLT PhotoTherapeutics initiated the trial.

"We determined that to get Visudyne therapy to patients on a compassionate-use basis would involve a certain expense,” he said. “We evaluated the idea and decided it was the best thing to do."

Now each of those 200-plus sites is capable of offering Visudyne therapy to appropriately selected patients literally the day FDA approval is granted.

“Upon FDA approval this will give patients across the country better access to treatment,” Mr. Lang said. “Our original TAP study had 16 sites across North America. If we came up to the launch of Visudyne with just those 16 sites, we would now have to work feverishly to meet patient demand.”

Professional, patient education

Education on two fronts will also be important to the success of Visudyne: first, to fully inform ophthalmologists about the indications, safety and effectiveness of the therapy and second, to inform patients about what AMD is and how it can be detected and treated.

“We will provide physicians with all the clinical information they need about Visudyne,” Mr. Lang said. “We also will provide practice management and reimbursement support.”

Without patients, of course, the treatment, reimbursement and other issues are moot. Research has shown that people misunderstand the purpose of eye examinations and know little about AMD. A new nonprofit organization was established to study and attempt to fix the problem.

“CIBA Vision was responsible for creating the AMD Alliance International,” Mr. Lang said. “We brought all of the members together and helped them establish their organization, their charter and their strategy. But the AMD Alliance International will never endorse a company, drug or therapy. Their goal is to increase awareness of AMD on a global basis.” (See sidebar, “Alliance targets misinformed”.)

On the horizon

The anticipated FDA approval for Visudyne would be not the end but a milestone in a long journey of product development, according to CIBA Vision.

“We do hope Visudyne will be approved for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization,” Mr. Lang said. “But that would only be the first step.”

There are currently ongoing clinical trials of Visudyne for:

  • Predominantly classic CNV. Continuing follow-up of patients treated in the original Treatment of AMD with PDT, or TAP study will further refine the treatment methods.
  • Occult AMD-related CNV and CNV in pathologic myopia. The Visudyne In Photodynamic Therapy (VIP) trial, currently in phase 3, should clarify the appropriateness of the treatment for these patients.
  • Presumed ocular histoplasmosis syndrome. This is a pilot study with about 30 patients enrolled so far.

“By no means are we going to stop this work if we get FDA approval for Visudyne,” Mr. Lang emphasized. “This company — from Novartis on down — is committed to posterior segment eye care. We are investigating many compounds right now, including protein kinase inhibitors, that maybe someday down the road will stop the onset of AMD. Some may even act like a vaccine.

“Visudyne is just the beginning of our investment in posterior segment care.”

For Your Information:
  • Stephen H. Lang is executive director, retina sales and marketing, U.S. ophthalmics, CIBA Vision, 11460 Johns Creek Parkway, Duluth, GA 30097-1556; (678) 415-3646; fax: 678-415-2575; e-mail steve.lang@cibavision.novartis.com.