LumiThera releases results of TORPA II study for dry AMD
LumiThera Inc. released clinical data results from the TORPA II study of non-invasive photobiomodulation (PBM) treatment in dry age-related macular degeneration (AMD) subjects.
Clinical data from 42 eyes in 24 dry AMD subjects demonstrated a significant improvement in mean visual acuity (VA) of 5.90 letters on completion of the three-week treatment and maintained at 5.14 letters after three months. Contrast sensitivity (CS) improved significantly at three weeks and three months.
An independent retinal-imaging expert conducted the anatomical assessments of the morphology. Drusen volume decreased by 0.024 mm, and central drusen thickness was significantly reduced by a mean of 3.78 µm, while overall central retinal thickness and retinal volume remained constant.
This is the first instance of statistically significant improvement in both functional clinical VA and CS and objective anatomical (OCT drusen volume and central drusen thickness reduction) findings reported in dry AMD subjects with PBM therapy, according to the company. The results demonstrate a sustained and potential disease modifying effect following a short non-invasive PBM treatment course.
The results have led to the design of the Lightsite study, a 30-subject, randomized, double-masked, sham-controlled clinical trial currently enrolling in Canada. The study is partially funded by a NIH National Eye Institute grant to LumiThera and will utilize the LT-300 instrument and multi-wavelength protocol.
"As we move toward the commercialization of LT-300, clinical studies such as TORPA I and II and LIGHTSITE will provide critical patient data and protocols necessary for long-term acceptance in the ophthalmic community," says LumiThera CEO Clark Tedford, PhD, in a statement.