The presentation outlined the feasibility and tolerability of the SalutarisMD investigational treatment for wet AMD using a single dose of episcleral brachytherapy in conjunction with intraocular anti-VEGF injections. The six subject study produced encouraging results. At three months, all patients experienced increases in BCVA (best-corrected visual acuity, mean + ETDRS letters). At 24 months, two subjects required no further anti-VEGF injections during follow-up and four continued to demonstrate improved or stabilized BCVA (mean +11.5 letters, with a range of +4 to +25 letters).
The procedure was readily performed [by Drs. Reid Schindler, Leonard Joffe, and Baldassarre Stea, Principal Investigators for the study] and well tolerated with no serious adverse effects. “The device allows patient-specific targeting of the application of radiation through the posterior sclera. This placement allowed for consistent, stable and repeatable control of the distance to the target tissue without violating the intraocular space,” explained Dr. Marsteller. This device is distinguished by its precision and lesion-specific targeting, which enable the retina specialist to deliver precisely localized tissue irradiation, customized for each patient.
The SalutarisMD device is designed to enable retina specialists to administer therapy in the same clinical environment (the physician's office or other outpatient facility) currently used to administer anti-VEGF injections. Placement and treatment are straight forward and performed under local anaesthesia in approximately 15 minutes.
In this study, six patients received 24Gy radiation over 5.5 minutes directly to the macular CNV by positioning the SMD-1 brachytherapy probe adjacent to the macular sclera via a subtenon retrobulbar approach. The probe was then removed. Patients also received concomitant anti-VEGF injections with re-administration as needed. Adverse effects and changes in BCVA and macular thickness were evaluated monthly. These long-term outcomes utilising SalutarisMD technology show promise for the treatment of wet AMD. Dr. Marsteller said, “We would like to thank the Ophthalmology Futures European Forum for supporting our presentation of this research. Our hope is that this technology will ultimately improve the lives of those suffering from this debilitating disease.”
Also announced was a second generation of the SalutarisMD device. “This new device features an improved, more uniform dosimetry profile to better encompass the entire neovascular lesion, which is designed to improve treatment response,” said Dr. Marsteller.
About the Ophthalmology Futures European Forum
Ophthalmology Futures European Forum hosts a diverse panel of key members of the ophthalmology community from industry, academia and financial investment practices, discussing the future of ophthalmological specialties. The Forums are aimed at examining where ophthalmology is going in the future and providing an opportunity for cross fertilization and development of ideas. For more information visit www.ophthalmology-
Caution: Investigational Device. Limited by Federal Law to Investigational Use in the United States.
Amanda Thomas, UK Communications Director
+44 (0) 1582 623660/+44 (0) 7746 708500 mobile
Joanne Vitali, US Communications Director
Salutaris Medical Devices, Ltd.
Imperial College London SW72AZ
+44 (0) 203 282 7166
Salutaris Medical Devices, Inc.
4330 N. Campbell Ave.
Tucson, AZ 85718