FDA rejects implantable telescope

September 1, 2006

An FDA panel has recommended against the approval of VisionCare Ophthalmic Technology's Implantable Miniature Telescope (IMT).

An FDA panel has recommended against the approval of VisionCare Ophthalmic Technology's Implantable Miniature Telescope (IMT).

The prosthetic telescope, together with the cornea, acts as a telephoto system to enlarge images. The telephoto effect allows images in the central visual field to focus, not on the damaged macula, but over other healthy areas of the central and peripheral retina. This generally helps reduce the 'blind spot' impairing vision in patients with age-related macular degeneration (AMD), hopefully improving their ability to recognize images that were either difficult or impossible to see.

The surgery to implant the telescope is relatively difficult and can lead to damage to the inside of the cornea. Patients may also experience a higher rate of loss of the cells lining the cornea. Some ophthalmologists were initially concerned that the weight of the device could cause problems, however this was not bourn out in trials.

First Er,Cr:YSGG laser gets the go ahead

Biolase Technology's Oculase MD laser system has received 510(k) clearance from the FDA.

The Oculase system combines water and laser technology to enhance surgical processes and outcomes for various ophthalmic applications. FDA-cleared indications include the incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit. It represents the first Er,Cr:YSGG laser system to be cleared for ophthalmic applications.

Alcon delighted by Japanese approvals

Patanol ophthalmic solution (olopatadine hydrochloride 0.1%) is indicated for the treatment of allergic conjunctivitis and provides both mast cell stabilizing and anti-histamine properties in a single molecule. Patanol is currently approved in 83 countries around the world, including the US where it is the leading product for the treatment of ocular allergies.

Vegamox (moxifloxacin hydrochloride 0.5%) is a fourth generation fluoroquinolone eye drop for the treatment of bacterial infections, including conjunctivitis and keratitis as well as for surgical prophylaxis. Alcon claims that its near neutral pH of 6.8 also provides for ocular comfort. Vegamox solution is currently approved as Vigamox in more than 40 countries around the world.

Alcon hopes that the two approvals will represent a significant business opportunity as Japan is the second largest ocular allergy market in the world.

ReNu recall update

Clusters of ulcerative keratitis among soft contact lens wearers caused by the fungus fusarium, have now officially been reported across the US and Singapore, according to a report in the Archives of Ophthalmology, published online on June 12, 2006.

A total of 66 cases occurred in Singapore between March 2005 and May 2006 and Dr Eduardo Alfonso of the Bascom Palmer Eye Institute, Florida, USA reported that, while between 1969 and 1992 he had seen just 10 cases, between January 2004 and April 2006 he has seen 34 cases.

In many cases, but not all, the patients were using Bausch & Lomb's ReNu brand of lens cleaning solutions, most commonly ReNu with MoistureLoc. Bausch & Lomb was forced to recall the product on May 15 of this year after the clusters of cases came to light.

However, there was some evidence to suggest that the infection was as a result of poor hygiene practices, with 80% reporting that they wore the lenses overnight and used them past their replacement date.

Crystalens takes the world by storm

Crystalens accommodating lenses have been implanted in more than 50,000 eyes worldwide since its approval by the FDA in November 2003.

Related Content:

Articles