SEATTLE, May 5, 2016 /PRNewswire/ — LumiThera® Inc., a late stage developmental medical device company creating a non-invasive photobiomodulation (PBM) treatment for ocular disorders and disease today announced that Graham Merry, MBBS presented clinical data results from the TORPA II study in Dry Age-Related Macular Degeneration (AMD) subjects at the Association for Research in Vision and Ophthalmology conference in Seattle with over 10,000 attendees.
The clinical data from 42 eyes in 24 dry AMD subjects demonstrated a significant improvement in mean visual acuity (VA) of 5.90 letters (p < 0.001) on completion of the 3-week treatment and maintained at 5.14 letters (p < 0.001) after three months. Contrast sensitivity (CS) improved significantly (log unit improvement of 0.11, p = 0.02) at three weeks and three months (log unit improvement of 0.16, p = 0.02).
Anatomical assessments of the morphology were conducted by an independent retinal-imaging expert. Drusen, the hallmark sign of dry AMD pathology was assessed. Drusen volume decreased by 0.024 mm3 (p < 0.001) and central drusen thickness was significantly reduced by a mean of 3.78 µm (p < 0.001), while overall central retinal thickness and retinal volume remained constant. “The reduction of the drusen size was statistical significant and the treatment has shown clinical benefit,” stated Marion Munk, MD PhD.
This is the first instance of statistically significant improvement in both functional clinical VA and CS and objective anatomical (optical coherence tomography (OCT) drusen volume and central drusen thickness reduction) findings reported in dry AMD subjects with PBM therapy. The results demonstrate a sustained and potential disease modifying effect following a short non-invasive PBM treatment course.
“We are inspired by the results of the study. Our goal is to stop disease progression and improve vision to the underserved dry AMD patient population,” said Graham Merry, MBBS. “These results confirm our earlier TORPA I clinical outcome data and provide further anatomical evidence for the patient following our multi-wavelength PBM approach.”
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, Inc. and will utilize the LT-300 instrument and multi-wavelength protocol for the ophthalmologist office.
“As we move toward the commercialization of the 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,” said Clark Tedford, PhD and CEO of LumiThera.
About Age Related Macular Degeneration
AMD accounts for 8.7% of all blindness worldwide and is the most common cause of blindness according to the World Health Organization. Disease prevalence is likely to increase due to population aging. Approximately, 85-90% of AMD is the “dry” form of the disease. The emotional and socioeconomic impact of AMD is large because of the reading and driving visual impairment caused by the disease, which primarily affects central (straight-on) rather than peripheral (side) vision.
About LumiThera Inc.
LumiThera, Inc. is a developmental-stage medical device company focused on treating patients affected by dry AMD. The Company’s expertise is in the application of PBM, using non-invasive light emitting diodes (LED) and laser treatments for acute and chronic ocular diseases and disorders. The Company is developing an ophthalmic LED office-based instrument to be used in multiple ocular conditions or disorders as non-invasive medical treatments.
The LT-300 is currently in clinical trials and is not CE Marked nor FDA 510K Cleared.
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Visit the Company’s website at www.lumithera.com.
SOURCE LumiThera Inc.