Navigated laser therapy may reduce retinal disease treatment burden, improve cost-effectiveness

Enhancements to laser photocoagulation may enable stabilization of anti-VEGF visual outcomes, according to a presentation at the Ophthalmology Innovation Summit.

Issue: April 25, 2012

In addition to improving upon the accuracy and visual outcomes of conventional laser therapy, a retina navigation system may help reduce retinal disease treatment burden and cost, a company executive said.

“Studies have shown, in the past, that we can provide much more accurate treatment in terms of laser application, but more importantly, it was shown that we can cut significantly the re-treatment rates in half compared to standard conventional laser therapy, which basically provides a faster stabilization in vision,” Winfried Teiwes, PhD, CEO of OD-OS, said at the Ophthalmology Innovation Summit in Orlando, Fla.

Winfried Teiwes

The Navilas Laser System (OD-OS) enables real-time imaging of the retina, allowing users to navigate on the retina and through treatment. According to Dr. Teiwes, studies performed by retina specialists have shown that the method improves placement accuracy by one-third, stabilizing vision faster and potentially maintaining acuity gains achieved through anti-VEGF treatment.

“The OD-OS goal is to provide a tool which stabilizes or catches the benefits obtained with [anti-VEGF] drugs and … reduces the number of patients under treatment and the cost,” he said.

Using Navilas, surgeons plan therapy on a digital image and can document treatment locations, Dr. Teiwes said. Enhanced accuracy and subsequent lower re-treatment rates, as suggested by the studies, also reduce complication risks.

Motivations for navigated therapy

The retinal disease treatment market has grown rapidly in recent years, partially due to worldwide obesity and aging trends but also due to chronic drug therapy, Dr. Teiwes said. In clinical practice, anti-VEGF injections are applied as often as once a month, and as indications for such therapy continue to expand, overall treatment burden and cost also increase.

For example, standard care for diabetic macular edema has transitioned from laser photocoagulation to anti-VEGFs as a consequence of improved anatomic and visual outcomes; however, this switch has led to increased financial strains on the health care system and also a higher treatment burden, Dr. Teiwes said. Navigated laser may help stabilize vision with fewer office visits, thus decreasing both burden and cost.

“Overall, compared to conventional laser, we are offering better medicine in combination with a higher cost-effectiveness,” Dr. Teiwes said.

Available and forthcoming data

The Navilas system received U.S. Food and Drug Administration approval in 2009, and initial studies have demonstrated its effectiveness in treating retinal vascular disease. While the system was initially pursued for diabetic macular edema and proliferative diabetic retinopathy, it is currently being evaluated for its added benefit in indications such as retinal vein occlusion and perifoveal abnormalities.

“We are now focusing on market access, for which we are looking for financing in the next year and to provide solid clinical evidence for reduced burden and to expand the platform to other diseases,” Dr. Teiwes said.

He said there is potential for combination therapy with anti-VEGF agents, noting that once initial injections reduce disease severity, navigated laser may provide stabilization that ultimately reduces or eliminates the need for anti-VEGFs. According to Dr. Teiwes, this approach has already been suggested effective in early, unpublished studies in the United States and Europe.

“For investors, finally, Navilas is an exciting opportunity that provides a sustained product platform for growing retinal disease,” Dr. Teiwes said. – by Michelle Pagnani

References:

Kozak I, Kim JS, Oster SF, Chhablani J, Freeman WR. Focal navigated laser photocoagulation in retinovascular disease: clinical results in initial case series [published online ahead of print Aug. 19, 2011]. Retina. doi:10.1097/IAE.0b013e318227ab5b.
Kozak I, Oster SF, Cortes MA, et al. Clinical evaluation and treatment accuracy in diabetic macular edema using navigated laser photocoagulator Navilas. Ophthalmology. 2011;118(6):1119-1124.

For more information:

Winfried Teiwes, PhD, can be reached at OD-OS, Berlin, Warthestr. 21, D-14513 Teltow, Germany; 49-3328-31282-111; or OD-OS, 31 Journey, Suite 120, Aliso Viejo, CA 92656; 949-415-7257; email: winfried.teiwes@od-os.com.
Disclosure: Dr. Teiwes is CEO of OD-OS.