Positive results from Salutaris’ episcleral brachytherapy trial on Wet AMD

Jun 15 2012

Positive results from a trial of episcleral brachytherapy to treat Wet Age-related Macular Degeneration (Wet AMD) were presented today at the ARVO Drug and Gene Delivery to the Back of the Eye Conference. The case reported was drawn from a Phase 1 study to assess the safety of this new investigational therapy for the leading cause of vision loss and blindness. Salutaris Medical Devices, Inc. (SalutarisMD™) developed the device and sponsored the study.    

Presented was the clinical course of a 78 year-old man newly diagnosed with Wet AMD who experienced substantial improvement in visual acuity and required no additional anti-VEGF injections throughout one-year follow-up; visual acuity in the study eye demonstrated a gain in Best Corrected Visual Acuity (BCVA) of +13 ETDRS letters, with no sign of subretinal hemorrhage, fluid or macular edema, and resolution of the Pigmented Epithelial Detachment (PED) present at study enrollment.

Co-author, Dr. Laurence Marsteller, Chief Operating Officer, SalutarisMD, cautioned, "While the results presented are not intended to be extrapolated for statistical significance, this promising case report from the Phase 1 trial supports the need for additional research to confirm our preliminary observations."

The poster presentation included details of the device and the sub-Tenon episcleral approach to delivering brachytherapy that avoids adverse effects of more invasive approaches. The SalutarisMD device is designed to enable retina specialists to administer a practical procedural therapy that can be performed in the same clinical environment as current anti-VEGF injections: a physician's office or other outpatient setting under local anesthesia, in approximately 15 minutes. The intraocular space is never violated. Episcleral placement allows for consistent, stable and repeatable control of the distance to the target tissue. Utilizing this minimally invasive technology, the retina specialist delivers precise, lesion-specific, localized tissue treatment.

"What is most intriguing about the study is that the application of radiation is done through the posterior sclera, thus avoiding the need for vitreous surgery," said Dr. Reid Schindler, principal investigator of the study, a clinical ophthalmologist and retina specialist with Retina Specialists of Southern Arizona, and clinical associate professor, University of Arizona Department of Ophthalmology.

Michael Voevodsky, President and CEO of SalutarisMD, said, "It was a privilege to have the SalutarisMD technology presented at this prestigious gathering. We believe our investigational therapy for treating Wet AMD has the potential to improve the quality of life for persons suffering from this debilitating disease. We are excited about the prospect of conducting additional clinical trials to further test our approach and its ability to positively effect clinical outcomes."

The purpose of the ARVO Conference, Drug and Gene Delivery to the Back of the Eye: from Bench to Bedside, "is to share cutting edge science, based on drug product development principles among a diverse group of participants" and it focuses "on topics related to current and emerging technologies for drug/gene delivery for the treatment of diseases of the back of the eye," according to the event description.