The Centers for Medicare & Medicaid Services last month granted Alcon's AcrySof IQ intraocular lens a New Technology Intraocular Lens (NTIOL) classification. The designation is effective on May 19, 2006 and will increase the Medicare payment to ambulatory surgery centers for cataract surgery by $50 when surgery is performed with an AcrySof IQ IOL. This NTIOL subset and adjusted payment for the AcrySof IQ IOL will remain in effect until February 27, 2011.
The AcrySof IQ IOL is an aspheric lens that is designed to reduce spherical aberration and has been shown to improve night driving performance versus a conventional spherical IOL.
"We are pleased that CMS has recognized the clinical advantages that patients gain from this advanced lens technology versus conventional IOL implants," said Kevin Buehler, Alcon senior vice president and chief marketing officer. "Studies have shown that by reducing spherical aberration, the AcrySof IQ IOL enhances image quality and improves contrast sensitivity."
FDA Approves Allegretto for Mixed Astigmatism
In early May, WaveLight's Allegretto Wave excimer laser received U.S. Food and Drug Administration approval to treat mixed astigmatism of up to 6 D.
The agency based its approval on the results of a multicenter clinical study of 162 eyes with mixed astigmatism. Sixty-eight percent of the 142 eyes available for the three-month follow-up achieved vision of 20/20 uncorrected, and 96 percent saw 20/40. In terms of spherical correction, 94 percent were within 0.5 D of the intended refraction, and 99 percent were within a diopter of their target. With regard to cylinder, 77 percent of eyes were within 0.5 D of their intended correction and 95 percent were within a diopter. According to patient questionnaires, the overall average level of glare and night-driving complaints improved.
In addition to correcting the refractive errors in these complex eyes, the company says the treatment allows surgeons to conserve tissue during the treatment, since the previous method used to correct these eyes involved both a myopic and a hyperopic treatment to be performed in succession. With this approval, the mixed astigmatism can be addressed with one treatment.
WHO Proposes Central Clinical Trials Registry
The World Health Organization is urging research institutions and companies to register all medical studies that test treatments on human beings, including the earliest studies, whether they involve patients or healthy volunteers. As part of the International Clinical Trials Registry Platform, a major initiative aimed at standardizing the way information on medical studies is made available to the public through a process called registration, WHO is also recommending that 20 key details be disclosed at the time studies are begun.
The initiative seeks to respond to growing public demands for transparency regarding all studies applying interventions to human participants, known as clinical trials. Before making the recommendations announced today, the Registry Platform initiative consulted with all concerned stakeholders, including representatives from the pharmaceutical, biotechnology and device industries, patient and consumer groups, governments, medical journal editors, ethics committees, and academia over a period of nearly two years.
"Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants," said Dr. Timothy Evans, assistant director-general of the World Health Organization.
Although registration is voluntary, there is a groundswell of policies aimed at spurring registration of all clinical trials. In July 2005, for example, the International Committee of Medical Journal Editors, a group representing 11 prestigious medical journals, instituted a policy whereby a scientific paper on clinical trial results cannot be published unless the trial had been recorded in a publicly accessible registry at its outset.
Some groups have raised concerns that these new requirements could jeopardize academic or commercial competitive advantage if they apply to preliminary trials of new interventions. Similar concerns have been voiced about the requirement to disclose certain items—such as the scientific title of the study, the name of the treatment being tested and the outcomes expected from the study—at the time of registration.
"Our aim is to make clinical research transparent and enhance public trust in science, but we are engaged in a fair and open process with all stakeholders. We look forward to continued dialogue about trial registration and results reporting as we move forward with the Registry Platform," said Dr. Ida Sim, associate director for Medical Informatics at the University of California, San Francisco, and coordinator of the Registry Platform initiative.
The planned Registry Platform will not be a register itself, but rather will provide a set of standards for all registers. It has not only standardized what must be reported to register a trial but is creating a global trial identification system that will confer a unique reference number on every qualified trial.
Currently, there are several hundred registers of clinical trials around the world but little coordination among them. The Registry Platform seeks to bring participating registers together in a global network to provide a single point of access to the information stored in them.
Later this year, the WHO Registry Platform will launch a web-based search portal where scientists, patients, doctors and anyone else who is interested can search among participating registers for clinical trials taking place or completed throughout the world.
EC Approves Allergan Combo Glaucoma Drug
Allergan received the license from the European Commission to market Ganfort, Allergan's Lumigan/timolol combination product (bimatoprost/timolol ophthalmic solution) for the treatment of glaucoma, in the European Union.
Ganfort is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues. A fixed combination of bimatoprost 0.03% and timolol maleate 0.5%, Ganfort offers IOP-lowering efficacy comparable to the free combination of these two agents, and greater efficacy than monotherapy with either agent used alone, Allergan reports. Ganfort provides IOP control in a once-daily dose, and in clinical trials also had a superior tolerability profile, including 40 percent less hyperemia compared to bimatoprost monotherapy.