LumiThera Presents US LIGHTSITE III Trial Data Showing Improvement in Vision in Intermediate Dry Age-Related Macular Degeneration

SEATTLE, June 22, 2022 /PRNewswire/ -- LumiThera Inc., a commercial stage medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced detailed findings in its LIGHTSITE III, multi-center clinical trial in non-neovascular (dry) Age-Related Macular Degeneration (AMD) subjects treated with Photobiomodulation (PBM) using the Valeda® Light Delivery System.

LIGHTSITE III, a prospective, double-masked, randomized, multi-center clinical trial, was conducted at ten leading US retinal centers. The objective was to treat non-neovascular (dry) AMD subjects with PBM every four months for a duration of 24 months. One hundred (100) subjects were enrolled in a 2:1 ratio of PBM to sham in the treatment groups. The mean age was 75 years and mean dry AMD duration since diagnosis was 4.9 years prior to trial enrollment.  Baseline best corrected visual acuity (BCVA) letter scores observed were a mean + SEM of 69.4 + 0.8 and 70.1 + 0.7 in the sham and PBM treatment groups, respectively. The majority of subjects were considered to have intermediate dry AMD. The analysis included 91 eyes in the PBM treatment group and 54 eyes in the sham treatment group in the modified intent to treat population.

The trial results demonstrated statistically significant improvement in the prespecified primary endpoint in BCVA at 13 months in the PBM treatment group over the sham-treatment group (p = 0.02). A sustained, mean increase in ETDRS letter score of ~5.5 letters from baseline was seen at the 13-month timepoint in PBM-treated subjects (p < 0.0001). In the PBM treatment group responders, 55% of the subjects showed a >5 letter improvement on the standard EDTRS eye chart with a mean of 9.7 letters and 26% achieved a >10 letter improvement with a mean of 12.8 letters.

In addition to improvements in BCVA, anatomical measurements in PBM-treated subjects demonstrated no significant increase in drusen pathology at 13 months compared to baseline while sham subjects continued to see numerical increases in drusen deposition. Drusen deposition is the hallmark pathology for diagnosis of dry AMD which leads to chronic inflammation and is associated with disease progression and cell loss. A negative correlation was observed between lower drusen volume pathology and improvement in BCVA with PBM (Spearman correlation, -0.3, p = 0.004).

The advance to later stage disease pathology such as the neovascular (wet) form or the development of Geographic Atrophy (GA), i.e., loss of retinal tissue in naïve patients was evaluated. The % conversion of dry AMD to the wet form was 1.8% for sham, 5.4% for PBM and 8.3% for the non-study eye groups at month 13. A few patients had GA (9 eyes at screening), and were distributed evenly between 5 PBM and 4 sham eyes at baseline.  At month 13, 6 additional eyes progressed with new GA identified.  Overall, a total of five of 55 sham eyes progressed to new GA (9.1%) versus only 1 of 93 PBM eyes progressed to new GA (1.1%) at month 13.

"The subjects had good starting vision with approximately 70% having between 20/32 to 20/40 vision. Study subjects were only enrolled in the study if their vision was 20/32 to 20/100 and no evidence of GA in the central macula." stated Diana Do, MD, and Quan Dong Nguyen, MD, MSc, FARVO, Professors of Ophthalmology and members of the Retina Division at the Byers Eye Institute at Stanford University, a clinical site for the LIGHTSITE III trial. "Intermediate dry AMD patients have pathology and visual impairment consistent with earlier stages in the disease and have not lost retinal tissue by progressing to GA. Thus there is an opportunity to improve their vision while retinal tissue is still viable. Therapy with PBM using the Valeda Light Delivery System may serve a significant unmet need for many of our patients with dry AMD who now have the potential to improve their visual acuity with treatment."  

"The safety results from the LIGHTSITE III trial through the 13-month timepoint were excellent," stated René Rückert, MD, MBA, Chief Medical Officer, LumiThera. "We now have patients that have exited the 2 year study. We will continue to follow all patients for the full 24 months for safety.  To date the results are consistent with a very favorable safety profile and a non-invasive treatment that can target patients earlier in disease."

"A non-invasive approach such as PBM treatment with the Valeda Light Delivery System could have potential for high impact on the quality of life for dry AMD patients." said Eleonora Lad, MD, PhD, Associate Professor and Director of Ophthalmology clinical research at Duke University Medical Center, a participating site. "We have many patients that would be excited to benefit from any treatment that recovers or improves vision."

"Overall, the clinical results show improvements in vision; what is further interesting is the lack of drusen deposit in the PBM treated group, and potentially less patient conversions to wet form of disease," remarked Glenn Jaffe, MD, Robert Machemer Professor of Ophthalmology; Chief, Vitreoretinal Division and Director, Duke Reading Center, the central imaging center for the LIGHTSITE III study. "Patient progression to new GA was also evaluated and was less in the PBM group, and while the new GA progression numbers are small in this study group, all outcomes point in favor for PBM as a novel approach to treat dry AMD patients earlier in disease."

"The study continues to strongly support that Valeda PBM treatments can improve visual acuity." stated Clark Tedford, PhD, President and CEO, LumiThera. "Our commercial and clinical trial experience has demonstrated an excellent safety and clinical benefit profile and we plan on submitting a PMA to the FDA for U.S. approval."

The LIGHTSITE III data will be presented at the 34th International Congress of German Ophthalmic Surgery (DOC), which will take place in Nuremberg, Germany from June 23rd - 25th 2022. The LIGHTSITE III data will also be discussed at the OIC/WAVE 22 retina conference held in Vail, Colorado from June 22-25, 2022.

AMD is a leading cause of vision loss for people aged 65 and older.  Losing central vision can make it harder to see faces, drive, or do close-up work, such as cooking or home repairs.  The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).

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 visual disorders. The company is commercializing the office-based Valeda® Light Delivery System to be used by eyecare providers 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. Valeda is also available in select countries in Latin America. Valeda is not approved for use by the Food & Drug Administration (FDA) in the USA.

LumiThera recently acquired Diopsys, Inc. to further offer diagnostic and monitoring capabilities to eyecare specialists. Diopsys is a leader in modern visual electrophysiology medical devices that help eye care professionals analyze the entire visual pathway for visual and neuro-visual disorders.

Visit the Company's website at www.lumithera.com.

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