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Volume 10, Number 27
July 18, 2005
FDA mandates impotence drug label changes to indicate vision risk
CIBA sues J&J over lenses
Novartis, Eon Labs settle lawsuit
DME implant study begins
Allergan, Pharmacopeia form partnership
Endo ocular probes marketing agreement created by IRIDEX, Innovatech

FDA mandates impotence drug label changes to indicate vision risk

The Food and Drug Administration (FDA) approved updated labeling for Cialis (Eli Lilly, Indianapolis), Levitra (a venture of Bayer, GlaxoSmithKline and Schering-Plough), and Viagra (Pfizer, New York) to reflect a small number of post-marketing reports of sudden vision loss, attributed to non arteritic ischemic optic neuropathy (NAION). The FDA advised patients that experience sudden or decreased vision loss in one or both eyes to stop taking the medicines and promptly call a physician or health care provider. Agency officials also advised patients taking or considering taking the drugs to inform their health care professionals if they have ever had severe loss of vision, which might reflect a prior episode of NAION. Such patients are at an increased risk of developing NAION again. It remains unclear whether the erectile dysfunction medications were the cause of the loss of eyesight or whether the problem is related to other factors, such as high blood pressure, diabetes, or a combination of these health concerns, according to information from the FDA.

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CIBA sues J&J over lenses

CIBA Vision Corp. filed suit against Johnson & Johnson Inc.'s (New Brunswick, N.J.) Vistakon division for infringement of CIBA Vision's (East Hanover, N.J.) patent rights to its silicone hydrogel contact lens technology, according to information from CIBA. The lawsuit, which was filed by CIBA Vision in the Federal District Court for the Middle District of Florida, Jacksonville, seeks to halt a planned launch of a Johnson & Johnson silicone hydrogel extended wear contact lens. The CIBA Vision patents, known as the "Nicolson" patents, protect CIBA Vision's proprietary NIGHT & DAY and O2OPTIX breathable contact lens technology. These patents were the subject of protracted global litigation with Bausch & Lomb (Rochester, N.Y.) that resulted in a 2004 license granted to Bausch & Lomb in exchange for a royalty payment to CIBA through 2014 in the U.S. and 2016 in other countries. CIBA asked the court to issue a temporary restraining order to prevent Johnson & Johnson Vistakon from manufacturing, marketing and distributing the lens.

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Novartis, Eon Labs settle lawsuit

Novartis (Basel, Switzerland) and the other defendants in a lawsuit related to the acquisition of Eon Labs Inc. (Lake Success, N.Y.) reached an agreement in principle with the plaintiffs to settle the litigation pending before the Delaware Chancery Court, according to information from Novartis. Zodnas Acquisition Corp., an indirect wholly owned subsidiary of Novartis, is extending its cash tender offer to acquire all outstanding public shares of Eon Labs, Inc. Under the settlement the tender offer was extended to at least last Friday, July 15, 2005. The settlement does not affect the economic terms of the outstanding tender offer. The settlement is subject to the approval of the Delaware Chancery Court.

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DME implant study begins

The first clinical implants of the I-vation (SurModics Inc., Minneapolis, Minn.) intravitreal implant were completed as part of a Phase I Clinical Study assessing the safety and tolerability of the implant in patients with Diabetic Macular Edema (DME) under an Investigational New Drug (IND) application with the FDA, according to information from the company. The intravitreal implant is one of the drug delivery technologies acquired in January 2005 by SurModics in connection with the acquisition of InnoRx Inc., a drug delivery company that develops therapies for the ophthalmology market. The implant was inserted during a brief outpatient surgical procedure using local anesthesia. Early follow-up has shown the implant to be well tolerated. The implant delivers drugs on a sustained release basis for well over a year and may be removed once the drug has been fully released. Currently, the majority of treatments under development for AMD and DME require repeated injections into the eye every one to three months. A single implant could provide long-term, controlled drug release. It also could advance therapeutic treatment, improve patient compliance, reduce side effects, and improve efficacy, according to company officials.

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Allergan, Pharmacopeia form partnership

Pharmacopeia (Princeton, N.J.) entered into an agreement with Allergan Inc. (Irvine, Calif.) to evaluate proprietary active lead compounds discovered at Pharmacopeia in models of ocular disease, according to information from the companies. The agreement resulted in an upfront cash payment from Allergan to Pharmacopeia and may result in pre-clinical and clinical payments, plus milestone payments, and royalties on ophthalmology drugs developed by Allergan. Pharmacopeia has retained rights to the drugs' use in other therapeutic areas. Pharmacopeia's compounds target angiogenesis.

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Endo ocular probes marketing agreement created by IRIDEX, Innovatech

IRIDEX Corp. (Mountain View, Calif.) and Innovatech Surgical Inc. (Camden, N.J.) formed a marketing and licensing agreement, which gives IRIDEX an option for worldwide distribution rights to Innovatech's current and future disposable endo ocular probes. Innovatech will license IRIDEX's proprietary probe/laser connector, according to information from IRIDEX. The agreement aims to increase the probe offerings of IRIDEX to ophthalmologists and give customers more clinical versatility and a wider selection of probes compatible with IRIS Medical laser photocoagulators. IRIDEX will immediately begin distribution of Innovatech's Illuminating endo ocular probes and the Adjustable & Intuitive products for endophotocoagulation for the treatment of diabetic retinopathy, retinal breaks and detachments, and neovascular glaucoma. The illuminating probes combine white-light illumination with laser delivery in one hand piece. The illuminating probes also feature a bayonet-style tip design for simultaneous wide-field illumination and precise laser spots. The Adjustable & Intuitive endo ocular probes allow the fiber optic to be continuously adjusted over a wide range of angles for full coverage of the peripheral retina without removing the probe from the eye.

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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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