Thursday 2 May 2013

Oraya therapy reduces need for anti-VEGF injections in wet AMD

Results of Oraya Threaperutics’ INTREPID study show that a single does of Oraya Therapy significantly reduces the need for anti-VEGF injections for patients with wet AMD.
The study, which was published online in the journal Opthalmology this month (April 18), enrolled a total of 230 patients from 21 sites across five European countries. The investigators evaluated the effectiveness and safety of Oraya Therapy – a one-time radiation therapy – in conjunction with as-needed anti-VEGF injections.
The researchers reported that patients who had previously been treated with anti-VEGF for up to three years experienced a 32% reduction of injections and substantially drier retinas with Oraya Therapy compared with the control group. Moreover 25% of Oraya Therapy patients needed no further injections. 
Among the best responders to Oraya therapy, there was a 52% decrease in injections. 
“The results of the INTREPID study reported to date are encouraging for clinicians and individuals with wet AMD,” said lead investigator, Timothy Jackson, from King’s College Hospital in London. “The prospect of maintaining vision while needing fewer eye injections will appeal to any patient receiving anti-VEGF therapy, and for certain subsets in the trial there is the added advantage of an improved visual outcome.”
Oraya Therapeutics CEO, Jim Taylor, added: “It is rare for a new therapy to demonstrate improved patient outcomes while simultaneously offering the potential to significantly reduce treatment burden and costs.”
Oraya Therapy involves a low-voltage X-ray source along with advanced robotics, laser-guided positioning system and a patented methodology for eye stabilization and tracking. 
The procedure can be delivered in an outpatient setting, averages about 20 minutes and requires no post-treatment recovery period before resuming normal activity.

New DME drug released in the UK

A drug developed to treat chronic diabetic macular edema (DME) was made available in the UK on Monday (April 29). Announced by biopharmaceutical company Alimera Sciences, Iluvien is the first sustained release pharmaceutical product to be designed for the treatment of the sight-threatening condition. 
Iluvien is administered as an implant and works for up to 36 months. Injected into the patient’s eye, it delivers sustained sub-microgram levels of fluocinolone acetonide (FAc).
Alimera Sciences has submitted a Patient Access Scheme (PAS) to the National Institute for Health and Care Excellence (NICE), with its Appraisal Committee expected to meet on May 15 to discuss the submission. A 30-day review period is likely to follow.
If accepted, Iluvien would be funded for NHS use with chronic DME patients in England and Wales.
Dan Myers, president and chief executive officer at Alimera Sciences, said: "We are pleased that Iluvien is now available in the UK. We continue to work with NICE and are hopeful that our simple PAS will make Iluvien available to a larger group of chronic DME patients in England and Wales, who are considered insufficiently responsive to available therapies."