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Volume 7, Number 40
October 07, 2002
Nidek responds to media reports, seeks FDA hyperopia approval
Ista awaiting approvals of new glaucoma, vitreoretinal drugs
Anecortave acetate shows powerful efficacy in clinical trials
QLT, Novartis reach key milestone in Visudyne trial
ASCRS in key negotiations on Medicare physician payment issue
HHS prohibits pharmaceutical company financial incentives

Nidek responds to media reports, seeks FDA hyperopia approval

Last week's EyeWorld Week contained some inaccuracies about a ruling in a patent infringement lawsuit against Nidek Inc. No injunction against Nidek was issued by the court, which was located in Boston. ‚__The jury ruling that was made was against Nidek and not its customers,‚__ Nidek officials said. ‚__All users are free to continue using their equipment without any damages or per procedure fees whatsoever. Additionally, the case has impact in the U.S. only and not internationally.‚__ The company is set to file and ask for a full and complete review and appeal the verdict.

In other news, Nidek announced last week that it has submitted a premarket approval clinical module to the Food and Drug Administration for review. The company is seeking approval for the correction of hyperopia, hyperopic astigmatism, and mixed astigmatism using laser in-situ keratomileusis with the Nidek EC-5000 Excimer Laser System. It is the final step in gaining FDA approval to market and treat indications of hyperopia with the laser system.

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Ista awaiting approvals of new glaucoma, vitreoretinal drugs

Ista Pharmaceuticals Inc. reported that its Japanese partner, Senju Pharmaceutical Co. Ltd., last week submitted a new drug application to the U.S. Food and Drug Administration for a unique formulation of timolol for glaucoma treatment. Ista holds the marketing rights to the drug, which is named Istalol in the United States. The NDA for Istalol is based on preclinical studies in Japan combined with data from two U.S. clinical trials.

In other news, the company submitted the chemistry, manufacturing, and controls section of the NDA for Vitrase (hyaluronidase), which is being developed for the treatment of patients with vitreous hemorrhage. Ista said the submission was made under the FDA's fast-track designation, which allows for early submission of complete NDA sections before submission of the full NDA.

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Anecortave acetate shows powerful efficacy in clinical trials

Alcon's anecortave acetate continued to demonstrate effectiveness in reducing vision loss in patients with the wet form of age-related macular degeneration. The 12-month data from an ongoing study showed that anecortave acetate 15 mg was significantly better at preserving vision, preventing severe vision loss, and inhibiting lesion growth in the retina than a placebo. Of the patients treated, 79% lost fewer than 3 lines of vision at the 1-year visit, compared with 53% of patients in the placebo group.

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QLT, Novartis reach key milestone in Visudyne trial

QLT Inc. and Novartis Ophthalmics, the eye health unit of Novartis AG, last week announced the completion of patient enrollment for the Visudyne in Early Retreatment (VER) Phase IIIb clinical trial in patients with predominantly classic subfoveal choroidal neovascularization secondary to AMD. The VER trial involves an earlier, more aggressive treatment regimen to potentially improve the visual outcome for patients and compares the standard regimen of Visudyne (verteporfin for injection) therapy ‚_" every 3 months ‚_" with a more frequent regimen of every 6 weeks for the first 6 months of treatment. Study results are expected in the fourth quarter of 2003.

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ASCRS in key negotiations on Medicare physician payment issue

The likelihood that Congress will act this year on several pending health issues is slim, given the gridlock over Senate proposals to create a Department of Homeland Security and House preoccupation with appropriations bills. Senate Finance Committee Chairman Max Baucus (D-Mont.) and ranking member Charles Grassley (R-Iowa) are conferring with Senate leaders and the White House to find a legislative vehicle for a package of increases in Medicare physician and provider payments. The current Senate bill totals $43 billion, but this figure will be pared down in final legislation. Like its House counterpart, the bill now includes $11.5 billion for increased physician payments over 10 years. ASCRS is meeting with key senators and White House officials to urge the enactment of legislation to prevent further payment cuts.

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HHS prohibits pharmaceutical company financial incentives

The government issued guidance to the pharmaceutical companies last week that they must not offer any financial incentives to doctors, pharmacists or other healthcare professionals to prescribe or recommend particular drugs, or to switch patients from one medicine to another. The government informed the industry that many practices commonly used in the marketing and sale of prescription drugs could run afoul of federal fraud and abuse laws. Specifically, the government said that drug makers could not offer incentive payments or other ‚__tangible benefits‚__ to encourage or reward the prescribing or purchase of particular drugs by doctors, health plans or companies that manage drug benefits for employers and insurers. Read the guidance document at http://oig.hhs.gov/fraud/docs/complianceguidance/draftcpgpharm09272002.pdf

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EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: David F. Chang, M.D., chief medical editor; Bonnie An Henderson, M.D., cataract editor; Edward J. Holland, M.D., cornea editor; Reay H. Brown, M.D., glaucoma editor; Kerry D. Solomon, M.D., refractive editor; and John A. Vukich, M.D., international editor

For sponsorship opportunities or membership information, contact:
ASCRS•ASOA • 4000 Legato Rd. • Suite 700 • Fairfax, VA 22033 • Phone: 703-591-2220 • Fax: 703-591-0614 • Email: ASCRS

Opinions expressed in EyeWorld Week do not necessarily reflect those of ASCRS•ASOA. Mention of products or services does not constitute an endorsement by ASCRS•ASOA.

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