Alcon's laser gets the FDA thumbs up

June 1, 2006

Alcon has added another device to its product portfolio in the form of the LADAR6000 excimer laser with high-speed ablation, which received FDA approval last month.

Alcon has added another device to its product portfolio in the form of the LADAR6000 excimer laser with high-speed ablation, which received FDA approval last month.

The new system, which, according to the manufacturers, offers a 50% faster ablation rate than previous LADARVISION platforms, has been developed for use in LASIK and PRK and is based on a flexible platform that will allow for future upgrades.

After the news spread that a severe corneal fungal infection was allegedly associated with use of Bausch & Lomb's contact lens solution, Renu with MostureLoc, in the US, the product was withdrawn from all shelves nationwide. The US-based firm has now decided to pull the product from the worldwide market.

Following on from the initial claims made in the US of a rare eye infection, Fusarium keratitis, associated with use of the contact lens formula, reports filtered through of similar incidences in Hong Kong and Singapore.

Upon receipt of these reports, Bausch & Lomb immediately withdrew the product from these markets and launched a detailed investigation into the company's Greenville plant in the US, which manufactured the MoistureLoc product for the countries affected. Having now eliminated possible contamination, tampering, counterfeiting or sterility failure at the plant, Bausch & Lomb has now acknowledged that there may be some aspect of its MoisureLoc formula that increases the relative risk of Fusarium infection.

Now, a product that earned the US giant around $100 million in sales in 2005, has been withdrawn from the worldwide market while investigations continue.

STAAR approval

A preloaded IOL injection system, offering aspheric optic design, has received CE mark approval. Not yet approved in the US, the approval will allow STAAR Surgical to market the IOL for use in cataract surgery in 21 countries across Europe.

KS-3Ai, officially launched during the Italian Association of Cataract and Refractive Surgery/Italian Society of Ophthalmology (ISRS/SOI) joint annual meeting in May, is inclusive of the lens, cartridge and injector body in a single unit for convenience and a controlled sterile pathway directly to the eye.

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Wavelight riding high

FDA approval has been granted for an extended range of treatments that can be performed with Wavelight AG's Allegretto Wave to include the indication of mixed astigmatism.

The treatment system, already approved for use in Europe and the US, is used for the LASIK correction of myopia, hyperopia and astigmatism.

The new approval is based on a total of more than 160 successful treatments performed in the US in mixed astigmatism patients; 97% of treated eyes achieved a visus of 0.5 or better six months postsurgery.

Macugen linked to rare reactions

There have been spontaneous reports in the US of hypersensitivity reactions, including anaphylaxis/anaphylactoid reactions and angioedema, associated with the intravitreal administration of Macugen (pegaptanib sodium).

Approved in the US in December 2004 and in Europe in February of this year, for the treatment of neovascular age-related macular degeneration (AMD), Macugen has been heralded as a breakthrough in AMD treatment as it is the first, and only, anti-angiogenic therapy to be approved for this condition.

Reports of these rare hypersensitivity reactions has spurred the US FDA and Macugen's manufacturers, Pfizer, to revise the safety labeling for the product since no reports of anaphylaxis attributed to the use of Macugen were made during clinical trials.