FDA Approvals: Artisan Intraocular Lens, Expanded Indication for Contak Renewal CRT Devices, and Others

Yael Waknine

September 16, 2004

Sept. 16, 2004 — The U.S. Food and Drug Administration (FDA) has approved a new implantable intraocular lens for moderate to severe nearsightedness, the use of Guidant's cardiac resynchronization therapy defibrillators in patients without implantable cardioverter defibrillator indications, the use of a multivitamin infusion without vitamin K in patients receiving concomitant anticoagulation therapy, and the use of 150-mg ranitidine HCl in the treatment of heartburn.

Implanted Lens Reduces or Eliminates Nearsightedness

On Sept. 13, the FDA approved an intraocular lens (IOL) for permanent implantation in front of the natural lens (Artisan, made by Ophtec USA, Inc.) to reduce or eliminate moderate to severe nearsightedness in adults. The device is intended for use in patients with healthy eyes and stable vision. It should not be used in those with astigmatism over 2.5 diopters.

The lens does not correct astigmatism, and glasses may be required after implantation. Glasses may also be needed for reading and night driving.

The approval was based on a review of multicenter clinical studies involving lens implantation in 662 patients with moderate to severe nearsightedness. After three years, 92% of patients had 20/40 or better vision, and 44% had 20/20 vision or better.

The data also showed a continual loss of corneal endothelial cells at a rate of 1.8% per year over three years. The FDA notes that it is unknown whether the loss will continue at the same rate or what the long-term effects may be. To minimize potential long-term effects of the device on corneal health, the FDA has required the safety labeling to limit its use to patients with a density of corneal epithelial cells capable of withstanding loss over time.

Other adverse events included retinal detachment (0.6%), cataract development (0.6%), and corneal swelling (0.4%).

The FDA is requiring the company to conduct a five-year postmarketing study to evaluate the rates of retinal detachment, cataract development, and other complications.

ICD Indication No Longer Required for Guidant CRT-D

On Sept. 15, the FDA approved an expanded indication for cardiac resynchronization therapy defibrillators (CRT-Ds) made by Guidant (Contak Renewal, Contak Renewal 3, Contak Renewal 3 HE), allowing their use in ischemic and nonischemic heart failure patients (New York Heart Association class III or IV) who remain symptomatic despite stable, optimal pharmacotherapy (OPT) and have left ventricular dysfunction (ejection fraction of 35% or less) with QRS duration of 120 ms or higher. Patients are no longer required to have an implantable cardioverter defibrillator (ICD) indication to receive a Guidant CRT-D.

CRT-D therapy was previously reserved for heart failure patients at risk for sudden cardiac death, as demonstrated by spontaneous or induced arrhythmias or previous myocardial infarction.

The approval was based on the results of the multicenter Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial that involved more than 1,500 heart failure patients and was funded by Guidant.

The study results showed that CRT-Ds in combination with OPT significantly reduced the risk of all-cause mortality and time to first hospitalization, improved quality and duration of life, and reduced heart failure symptoms compared with OPT alone.

Pacemakers and defibrillators with CRT function (CRT-P, CRT-D) in combination with OPT reduced the risk of all-cause mortality and time to first hospitalization by 19% and 20% respectively, compared with OPT alone (P = .015; P = .011). CRT-D with OPT also reduced the risk of all-cause mortality by 36% compared with OPT alone (P = .004).

According to a company news release, the approval is exclusive to the company and not available to makers of rival products.

Multivitamin Infusion Without Vitamin K (M.V.I. – 12) for Patients on Anticoagulation Therapy

On Sept. 13, the FDA approved a supplemental indication for a multivitamin infusion without vitamin K (M.V.I. – 12, made by Mayne Pharma [USA], Inc.) for the prevention of vitamin deficiency and thromboembolic complications in patients receiving home parenteral nutrition concurrently with warfarin-type anticoagulation therapy.

Ranitidine (Zantac) 150 mg for Heartburn

On Sept. 1, the FDA approved a new indication for ranitidine hydrochloride 150 mg (Zantac, made by Pfizer Consumer Healthcare), allowing its use in the relief of heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages when taken 30 minutes to one hour preprandially.

Ranitidine was previously approved in the treatment of duodenal and gastric ulcers, pathological hypersecretory conditions, gastroesophageal reflux disease, and erosive esophagitis.

Reviewed by Michael W. Smith