SEATTLE, May 7, 2021 /PRNewswire/ — LumiThera Inc., a commercial stage medical device company delivering photobiomodulation (PBM) treatment for ocular damage and diseases, today announced research investigators lead by Drs. Hakan Kaymak, Inken Becker and Hartmut Schwahn, from the Macula Retina Centre of Breyer Kaymak & Klabe Eye Clinic in Dusseldorf, Germany presented positive clinical findings following PBM treatment with the Valeda Light Delivery System from an ongoing safety and efficacy study in Early Diabetic Retinopathy (DR) Patients with Central Macular Edema (DME) at the Association for Research in Vision and Ophthalmology Conference 2021.
This is the first retrospective systematic evaluation with the Valeda system in early DR/DME patients with good vision. The study investigated the beneficial effects of Valeda PBM on both objective and subjective visual function in early DME patients. A total of 30 eyes from 19 DME patients (56 ± 14 yrs, range: 27-76, 68% male) with good visual acuity (VA) and macula edema were treated with one series of 9 PBM treatments (about 3 times a week for 3 to 4 weeks).
The patients were assessed for multiple clinical, anatomical and safety outcomes. Wide field color fundus photography (Optos) prior to and after PBM treatment was assessed using diabetes retinopathy severity scale (DRSS) by an independent retinal expert. Optical Coherence Tomography (Zeiss) imaging assessments and patients´ subjective evaluations (via questionnaire) were conducted before PBM treatments at baseline (BL), after final treatment and at follow-up visits that extended up to 16 months.
“The results demonstrate the first time Valeda was tested in DME patients and showed improvement in both anatomical and clinical outcomes,” stated Hakan Kaymak, MD. “Previously, we have demonstrated the clinical benefits of PBM treatments in dry AMD patients in our clinic. Now we have extended the safety and effectiveness into early DME patients with good vision.”
After the Valeda treatment, the presence of intraretinal fluid (IRF) overall was reduced from 90% to 70% (p = 0.031). Presence of IRF in the central 1 mm reduced from 70% to 57% (p = 0.125). Hard exudates were present at BL and were significantly reduced by the PBM treatment from 66.7% to 46.7% (p = 0.031). Central Retinal Thickness at BL was 294 ± 51 µm and significantly reduced to 286 ± 42 µm (p = 0.027). After 9 PBM treatments the DRSS scores showed a 1 step improvement in 17% of the eyes, in 83% the DRSS score remained stable. More than 60% of the patients treated with one series of PBM for 3 to 4 weeks noted a continuation of their subjective improvement and a decreased disease influence on their daily life 4 months after the PBM treatments.
“Anatomical benefits and subjective patient evaluations suggest disease-modifying effect with PBM treatment in patients with early DME,” stated Hartmut Schwahn, PhD, Director of Research at Hakan Kaymak´s clinic. “The early DME patients typically had good vision and nearly normal CRT but clear evidence of macular edema. This data supports the safe and effective use of the Valeda and PBM in early diabetic retinopathy and macular edema patients.”
“There was no change in the other morphological efficacy and safety parameters including epiretinal membrane, disorganization of the retinal inner layers, and integrity of the outer retina during the whole follow-up period,” noted Professor Marion Munk, MD, PhD, Inselspital, University Hospital Bern and Bern Photographic Reading Center. “Several anatomical parameters showed a significant improvement without the need for invasive treatments. The PBM treatment was very well tolerated, and no signs of phototoxicity were observed based on functional and anatomical outcomes assessed.”
“We continue to evaluate Valeda treatments in ocular disease and damage,” stated Clark Tedford, Ph.D., President and CEO. This early case study demonstrates safety for Valeda treatments up to 16 months following PBM treatments in early DME patients and potential disease-modifying benefits on anatomical endpoints without resorting to invasive laser procedures or injections in the eye. We are planning formal prospective studies to further optimize treatment benefits.”
In 2018, LumiThera obtained a CE mark to commercialize the Valeda Light Delivery System in the European Union for the treatment of dry AMD. In 2020, LumiThera was awarded a SBIR phase II grant by the NIH to study the effects of the Valeda device in DME patients in the US.
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About LumiThera Inc.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular damage and disease including dry age-related macular degeneration, a leading cause of blindness in adults over 65. The company is a leader in the use of PBM for treatment of acute and chronic ocular diseases and disorders. The company has developed the office-based Valeda Light Delivery System to be used by eye care specialists as medical treatments.
The Valeda Light Delivery System has been granted authorization to use the CE Mark by an EU Notified Body as required for commercial use in the European Union only. Valeda is not approved for use by the Food & Drug Administration (FDA) in the USA.
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