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
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.