Article Date: 7/1/2013

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New AMD tool coming to US market

Technology could help provide much earlier diagnosis.

BY RENÉ LUTHE, SENIOR ASSOCIATE EDITOR

It’s long been established that impaired speed of dark adaptation is closely associated with AMD. According to retinal diagnostic device maker Maculogix (Hummelstown, Pa.), that impairment begins up to four years before AMD is clinically evident.

However, using that indicator to catch the disease in its early stages simply wasn’t feasible in the clinic; prior methods of measuring dark adaptation speed required 30 minutes to an hour. “There was the Goldmann-Weekers, which was literally World War II era technology,” says Gregory R. Jackson, PhD, and CSO of Maculogix. “It was completely manual, like the old-fashioned manual visual fields”— not exactly a good fit for today’s busy ophthalmology offices. So the company sought to develop a technology that could speedily gauge dark adaptation, identifying AMD patients earlier in the course of their disease when the clinician would have a greater chance of slowing its progress.

ENTER THE ADAPTDX

Once Maculogix identified dark adaptation and decided it would be an effective diagnostic for AMD the company turned its efforts to developing a test that would fit into the needs of the clinic. The result is the AdaptDX, set to make its commercial launch this fall.

A 2 ft x 2 ft x 2 ft cube-shaped device similar to a standard visual field perimeter houses the noninvasive test. It operates by exposing patients to a brief camera flash, then asks them to indicate whenever they see a progressively dimmer spot of light presented as a randomly timed flash at the edge of the macula. The test takes five minutes, and can be conducted by an ophthalmic technician. Training includes a 30-minute presentation followed by hands-on patient testing.

“If the technician has used another apparatus like the Humphrey Field Analyzer, they find the AdaptDx very similar in look and feel” Dr. Jackson says. “It doesn’t require much training.”

NEW INDICATION ON THE HORIZON?

The AdaptDx has already received FDA clearance as a dark adaptometer. The indication Maculogix is currently seeking, however, is that of an aid in the diagnosis of AMD. Data from additional clinical trials for the new indication, including a multi-site, cross-sectional study of 200 patients, were very encouraging, Maculogix reports. The company plans on presenting the details of the study in publications and at meetings later this year.

Dr. Jackson emphasizes that the AdaptDx would not be the only test an ophthalmologist would use to diagnose AMD. Fundus photographs and the usual battery of tests would also be necessary. Still, the early detection the AdaptDx affords would help get patients vision-saving care that could slow the progress of AMD much earlier in the course of the disease than is currently the case.

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The AdaptDx is “a potential breakthrough diagnostic for AMD,” maker Maculogix says.

“We envision that when a person is shown positive for the disease in the early stages, the very first thing you would do is put them on the AREDS supplementation, assuming they are suitable candidates,” Dr. Jackson says. Diagnosis begins the stage of watchful waiting on the clinician’s part, he says, increasing the frequency of check ups until the disease reaches the point where the clinician refers the patient to a retina specialist.

“We are very excited about the possibility of introducing the AdaptDx to the marketplace,” Maculogix CEO John Edwards says. “We will be at the Academy meeting in the fall too, so doctors can see our device there.” RP



Retinal Physician, Volume: 10 , Issue: July 2013, page(s): 66