At a "Late Breaking Development session" held in conjunction with the AAO's Retina Subspecialty Day, several interesting and promising approaches to the treatment of macular degeneration were presented.
In particular, the use of radiation as an adjunct to the gold standard of injecting anti-VEGF agents such as Lucentis or Avastin, both of which are manufactured by Genentech (South San Francisco, California), is showing great potential.
Pravin Dugel, MD, a managing partner of Retinal Consultants of Arizona (Phoenix) presented the results of the MERITAGE 1 trial. The trial employed a technique called epimacular brachytherapy, which incorporates a vitrectomy and the brief administration of a beta radiation source, strontium-90, to the macula.
The technology was developed by privately-owned, venture capital-backed NeoVista (Fremont, California).
The MERITAGE 1 study enrolled 50 patients, with the hypothesis that the addition of beta radiation could decrease the frequency of anti-VEGF injections and also improve visual acuity.
The study met both endpoints, as the number of injections six months after radiation decreased from an average of four per patient to two, while 63% of the patients gained additional visual acuity, with half the patients gaining 5 letters or one line on the reading chart more.
Dugel then noted that NeoVista's pivotal trial, dubbed CABERNET, recently completed its full enrollment of 450 patients. These results, which should support a PMA filing, are expected to be released in late-2010.
"We eagerly await the results of this important pivotal trial," said Dugel.
Another approach to using radiation to manage AMD was discussed by Peter Kaiser, MD, of the Cleveland Clinic Foundation (Cleveland). He presented early data on the IRay system a noninvasive, low-voltage, stereotactic radiosurgical device designed specifically for office-based ophthalmic use. IRay delivers a precise dose of radiation noninvasively through the sclera to the macula using a robotic positioning system, a proprietary localizing algorithm and a novel methodology for eye stabilization. It has been developed by privately-owned, venture capital-backed Oraya (Newark, California).
Oraya's feasibility trial has been conducted in Mexico and Kaiser reported on the results of the first 28 patients. Like NeoVista, its clinical data is showing that it both improves visual acuity and reduces the therapeutic burden with a reduction in the number of injections.
Oraya hopes to initiate its pivotal trial, which is unnamed as yet, in the first half of 2010. Oraya's new CEO Jim Taylor, former president of Carl Zeiss Meditec USA (Dublin, California) recently joked at a meeting last week that it would be called LIGHTBEER, a spoof on the wine-related names used by NeoVista.