NICE makes a U-turn on anti-VEGF decision

September 1, 2007

The National Institute for health and Clinical Excellence (NICE) in England is to delay issuing guidance on Lucentis and Macugen after an unprecedented patient outcry over its decision to block access to them.

The National Institute for health and Clinical Excellence (NICE) in England is to delay issuing guidance on Lucentis and Macugen after an unprecedented patient outcry over its decision to block access to them.

NICE originally recommended Lucentis (ranibizumab; Novartis) for use in just 20% of patients with age-related macular degeneration (AMD), but not until both eyes were affected and, even then, only in the healthier eye. Macugen (pegaptanib; Pfizer) was blocked altogether. Both drugs are members of the anti-VEGF class of agents.

Campaigners from the Royal National Institute of Blind People (RNIB) and the Macular Disease Society claim that if the original NICE recommendations had been followed it would condemn more than 20,000 people a year to blindness

Bevasiranib goes up against Lucentis

Opko Health has initiated the Phase III COBALT (Combining Bevasiranib And Lucentis Therapy) clinical trial of bevasiranib for the treatment of wet age-related macular degeneration (AMD).

The multinational trial aims to enrol more than 330 wet AMD patients and will assess whether bevasiranib, administered every eight or 12 weeks, is safe and whether it has equivalent efficacy to Lucentis (ranibizumab; Novartis), in preventing vision loss.

Bevasiranib is a first-in-class small interfering RNA (siRNA) drug designed to silence the genes that produce vascular endothelial growth factor (VEGF). It is the first therapy, based on the Nobel Prize-winning RNA interference technology, to advance to Phase III clinical trials.

Ex-PRESS better than trabeculectomy

In a prospective clinical study, 34 pseudophakic glaucomatous subjects, not controlled by topical therapy, were randomized into two groups to receive either the Ex-PRESS implant or undergo trabeculectomy. All subjects had a postoperative intraocular pressure (IOP) measurement over 24 mmHg.

In the Ex-PRESS group (17 subjects), preoperative IOP was 26±2.18 mmHg and in the trabeculectomy group (17 subjects) it was 26.7±1.98 mmHg. At one week follow-up the mean IOP had fallen to 14±4.2 mmHg (p=<0.001) and 15.4±3.6 mmHg (P=<0.001), in the Ex-PRESS and trabeculectomy group, respectively. In the Ex-PRESS group, two eyes required an anterior chamber (AC) viscoelastic refilling for AC flattening. In the trabeculectomy group, four eyes had choroidal detachment, three eyes had AC flattening requiring an AC refilling and two eyes had hyphema.

It was concluded that, not only is the Ex-PRESS as effective as trabeculectomy in lowering IOP, it is also safer.

AMO's lens solution linked to AK

A "strong association" has been discovered between use of AMO's Complete MoisturePlus Multi-Purpose Solution and an increased risk of Acanthamoeba keratitis (AK).

Earlier this year, AMO voluntarily recalled the product and since then an investigation of 30 AK cases and 39 matched controls wearing soft contact lenses, found that those with AK infection were significantly more likely to have reported use of the AMO solution than those without the infection. The researchers, from the University of Illinois, Chicago, USA, found that users of the solution have a greater than 16-fold risk of developing AK.

The researchers, however, also made it clear that 39% of AK cases reported no use of AMO Complete MoisturePlus Multi-Purpose solution. Furthermore, the investigation also offered some evidence that re-using contact lens solution, rubbing lenses during cleaning and showering with lenses on also increases the risk of infection.

The FDA is concerned that, despite the solution being withdrawn from the market, consumers might still be using it. The governing body therefore urges soft contact lens wearers to throw away any partially used bottles.