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Navilas® Navigated Laser Plus anti-VEGF Combination Therapy for Diabetic Macular Edema Shown to Reduce Retreatment Rates by More Than 50% While Stabilizing Visual Acuity

Study Shows Novel Combination Treatment Superior to Anti-VEGF Therapy Alone

Teltow, Germany – OD-OS, the world leader in navigated laser therapy for retinal disease management, congratulates Marcus Kernt MD (Ludwig Maximilians University, Munich) on his
compelling study results recently presented at EURETINA 2013. In his study, Dr. Kernt showed the combination of anti-VEGF injections and navigated laser photocoagulation for diabetic macular edema (DME) proved superior to anti-VEGF therapy alone. This prospective cohort study utilized the Navilas Navigated Laser System (OD-OS GmbH) in combination with Ranibizumab anti-VEGF therapy versus standard Ranibizumab monotherapy. In both patient cohorts, an initial loading phase of three injections was administered, followed by “as needed” (PRN) injections assessed monthly to maintain visual gains and central retinal thickness reductions. The combination cohort received one treatment with the Navilas Navigated Laser following the loading phase of 3 injections. At 12 months, 65% of the combination group required no further injections, while in the same period 84% of the monotherapy patients required additional injections to maintain effect. After the loading phase, an average of 4 injections were administered in the monotherapy group, while the combination cohort needed only 1 on average, representing a statistically significant difference. In both cohorts, visual gains remained similarly stable after the loading phase with overall 8.4 ETDRS letters gained in the combination cohort and 6.3 letters gained in the monotherapy cohort.

Previous work from Dr. Kernt established the efficacy of Navilas laser/tissue interaction with 96% of treatment spots delivered within 100 ?m of intended target1. A subsequent paper proved that, in the treatment of DME with laser monotherapy, Navilas reduced the required laser retreatments by almost half as compared to conventional laser therapy2. This study also showed a more precise and complete treatment with more predictable stabilization. Such evidence founded the hypothesis that Navilas Navigated Laser could provide a faster and more durable stabilization and possibly reduce the need for repeated anti-VEGF injections.

When asked about the results of his most recent study, Dr. Kernt stated “Navilas navigated laser therapy demonstrated significant and stable visual gains in most patients. These results were at least as good as with Ranibizumab monotherapy at a significantly lower number of injections when compared to those who received Ranibizumab monotherapy alone. Importantly, the results after navigated laser therapy are also superior to results of previously reported studies which were based on conventional laser/anti-VEGF combinations with regard to reducing the injection burden.“

The Navilas Navigated Laser was featured in several other presentations at EURETINA 2013, including papers by Igor Kozak, MD, PhD (Riyadh, Saudi Arabia) and Antonio Caimi MD (Milan, Italy). Lisa Toto, MD (Chieti, Italy) and Luca Di Antonio, MD (Chieti, Italy) were included in poster presentations. “We are extremely pleased with the body of work presented by these physicians at EURETINA 2013” stated Dr. Winfried Teiwes, CEO of OD-OS. “Dr. Kernt’s study” he continued “has validated the efficacy of the Navilas Navigated Laser in combination with anti-VEGF therapy. This compelling data is only the beginning as Dr. Kernt and others now embrace the technology to standardize and improve treatment of other retinal diseases. We feel this is very important as the market strives to find durable options to reduce the treatment burden of retinal disease globally.”

OD-OS GmbH is located in Teltow, Germany where it has commercialized the Navilas Navigated Laser in the US, Europe, Korea and India. Additional approvals are anticipated in Japan, China and Canada within the next 6 months as the technology is expanded into new indications for AMD, RVO and Glaucoma. Dr. Teiwes will be presenting the Navilas Navigated Laser on October 3 at the Ophthalmology Futures Forum 2013 which precedes the ESCRS Meeting in Amsterdam.

For further information, please contact:
Dr. Winfried Teiwes
winfried.teiwes@od-os.com
www.navilas.com



1 Kernt et al, “Pain and accuracy of focal laser treatment for diabetic macular edema using a retinal
navigated laser (Navilas®)," Clinical Ophthalmology 2012:6 289–296
2Kernt et al, “Navigated Macular Laser Decreases Re-Treatment Rate for Diabetic Macular Edema:
A Comparative Analysis to Conventional Macular Laser," accepted for publication in Clinical
Ophthalmology, October 2012

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