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Espansione Group is pleased to announce the release on the British Journal of Ophthalmology (2026) of a new publication from the multicenter LightWave I study on Age-related Macular Degeneration (AMD). The peer-reviewed publication shows how LM™ LLLT Photobiomodulation (PBM) on the eye-light® device led to significant and sustained improvements in patients with dry early and intermediate AMD over a 12-month period.
Key Findings from LightWave I (135 eyes, 73 patients at 12 months)
Anatomical Outcomes
Mean drusen volume (MDV) decreased in the PBM group (-0.03 ± 0.05 mm³, p < 0.0001), while it increased in the sham group (+0.02 ± 0.04 mm³, p < 0.0001).
Multilevel mixed-effects model revealed a significant interaction between PBM treatment and time on MDV at both M6 and M12, along with a significant positive association with female sex, AREDS category and a negative association with age.
Functional Outcomes
Best corrected visual acuity (BCVA) improved by +1.31 ± 5.6 letters in the PBM group, compared with a decline of –2.7 ± 5.7 letters in the sham group (p < 0.0001).
Safety Outcomes
PBM treatment was well tolerated, with no evidence of phototoxicity or treatment-related conversion to wet AMD.
“The combination of statistically significant anatomical and functional benefits, along with favorable safety profile, positions PBM as a promising therapeutic option for early-intermediate dAMD, for which no approved disease-modifying treatments currently exist.”
— Dr. Claudio Iovino, LightWave I Investigator
The findings build on previously published safety and tolerability data, providing the first longer-term evidence that PBM may represent a promising new approach to managing dry AMD.
About AMD
Age-related macular degeneration (AMD) is a leading cause of irreversible vision loss among older adults. Globally, the number of affected individuals is projected to rise from 196 million in 2020 to 288 million by 2040 [1]. In the United States alone, approximately 20 million people were living with AMD in 2019, of whom about 1.5 million had late-stage disease. While early and intermediate AMD are often asymptomatic, late-stage AMD can cause profound visual impairment, limiting key functions such as reading and face recognition [2,3].
Intermediate AMD (iAMD) represents a pivotal stage in disease progression, defined by the presence of large drusen and/or pigmentary abnormalities [4]. It directly precedes the onset of irreversible late-stage changes such as GA and is therefore an increasingly important target for therapeutic innovation. Yet, progress in this area remains limited, partly due to the lack of validated and widely accepted clinical trial endpoints [5,6].
About LM™ LLLT Photobiomodulation (PBM) in AMD
Photobiomodulation (PBM) is an emerging non-invasive therapeutic approach for age-related macular degeneration (AMD), targeting one of the key mechanisms underlying disease progression: mitochondrial dysfunction.[7-15] In AMD, retinal pigment epithelium (RPE) cells experience impaired mitochondrial activity, increased oxidative stress, and reduced cellular energy production, all of which contribute to retinal degeneration and vision loss. [9-14]
PBM uses specific wavelengths of visible light to stimulate cytochrome c oxidase within mitochondria, enhancing ATP production, improving cellular metabolism, and reducing reactive oxygen species (ROS). [15] In addition to its mitochondrial effects, PBM has demonstrated anti-inflammatory and antioxidant properties, promoting retinal cell survival under oxidative stress conditions. [16-17]
Preclinical studies in retinal degeneration models have shown that PBM can preserve photoreceptor structure, reduce inflammation, and improve visual function. [18-19] These findings have supported the clinical development of PBM in patients with early and intermediate AMD.
The LightWave I study is the first multicenter, controlled clinical trial designed to evaluate the safety and efficacy of LM™ LLLT Photobiomodulation (PBM) delivered through the eye-light® device in patients with dry AMD. Initial safety, tolerability, and short-term efficacy results were published in Ophthalmology & Therapy [20] confirming the absence of treatment-related adverse events and highlighting early functional improvements.
Viggiano et al. (Eye, 2025) [21] provided independent evidence of PBM’s potential, showing enhancement of choriocapillaris perfusion and outer retinal remodeling in intermediate AMD patients after short-term treatment.
The newly reported 12-month follow-up outcomes from LightWave I build on this body of evidence, reinforcing the potential of PBM as a safe, non-invasive therapy that may improve both anatomical and functional outcomes in patients with dry AMD.
References
Wong WL, Su X, Li X, Cheung CMG, Klein R, Cheng C-Y, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2:e106–16.
Jonas JB, Cheung CMG, Panda-Jonas S. Updates on the epidemiology of age-related macular degeneration. Asia Pac J Ophthalmol (Phila).2017;6 (6):493-497. doi:10.22608/APO.2017251.
Rein DB, Wittenborn JS, Burke-Conte Z, et al. Prevalence of age-related macular degeneration in the US in 2019. JAMA Ophthalmol. 2022;140(12): 1202-1208. doi:10.1001/jamaophthalmol.2022.4401.
Ferris FL, Wilkinson CP, Bird A, Chakravarthy U, Chew E, Csaky K, et al. Clinical classification of age-related macular degeneration. Ophthalmology. 2013;120:844–51.
Wu Z, Ayton LN, Luu CD, Guymer RH. Longitudinal changes in microperimetry and low luminance visual acuity in age-related macular degeneration. JAMA Ophthalmol. 2015;133:442–8.
Sassmannshausen M, Pfau M, Thiele S, Fimmers R, Steinberg JS, Fleckenstein M, et al. Longitudinal analysis of structural and functional changes in presence of reticular pseudodrusen associated with age-related macular degeneration. Investig Ophthalmol Vis Sci. 2020;61:19.
Borrelli E, Bandello F, Boon CJF, Carelli V, Lenaers G, Reibaldi M, Sadda SR, Sadun AA, Sarraf D, Yu-Wai-Man P, Barboni P. Mitochondrial retinopathies and optic neuropathies: The impact of retinal imaging on modern understanding of pathogenesis, diagnosis, and management. Prog Retin Eye Res. 2024 Jul;101:101264.
Kaarniranta K, Uusitalo H, Blasiak J, Felszeghy S, Kannan R, Kauppinen A, Salminen A, Sinha D, Ferrington D. Mechanisms of mitochondrial dysfunction and their impact on age-related macular degeneration. Prog Retin Eye Res. 2020 Nov;79:100858.
Sadun AA, Carelli V. The role of mitochondria in health, ageing, and diseases affecting vision. Br J Ophthalmol. 2006 Jul;90(7):809-10.
Terluk MR, Kapphahn RJ, Soukup LM, Gong H, Gallardo C, Montezuma SR, Ferrington DA. Investigating mitochondria as a target for treating age-related macular degeneration. J Neurosci. 2015 May 6;35(18):7304-11.
Canter JA, Olson LM, Spencer K, Schnetz-Boutaud N, Anderson B, Hauser MA, Schmidt S, Postel EA, Agarwal A, Pericak-Vance MA, Sternberg P Jr, Haines JL. Mitochondrial DNA polymorphism A4917G is independently associated with age-related macular degeneration. PLoS One. 2008 May 7;3(5):e2091.
SanGiovanni JP, Arking DE, Iyengar SK, Elashoff M, Clemons TE, Reed GF, Henning AK, Sivakumaran TA, Xu X, DeWan A, Agrón E, Rochtchina E, Sue CM, Wang JJ, Mitchell P, Hoh J, Francis PJ, Klein ML, Chew EY, Chakravarti A. Mitochondrial DNA variants of respiratory complex I that uniquely characterize haplogroup T2 are associated with increased risk of age-related macular degeneration. PLoS One. 2009;4(5):e5508.
Udar N, Atilano SR, Memarzadeh M, Boyer DS, Chwa M, Lu S, Maguen B, Langberg J, Coskun P, Wallace DC, Nesburn AB, Khatibi N, Hertzog D, Le K, Hwang D, Kenney MC. Mitochondrial DNA haplogroups associated with age-related macular degeneration. Invest Ophthalmol Vis Sci. 2009 Jun;50(6):2966-74.
Tan NRX, Chan KE, Lim BXH, et al. Photobiomodulation: evidence and applications in ophthalmology. Curr Opin Ophthalmol. 2025 Sep 1;36(5):345-381.
de Freitas LF, Hamblin MR. Proposed mechanisms of photobiomodulation or low-level light therapy. IEEE J Sel Top Quantum Electron. 2016;22:348–64.
Dompe C, Moncrieff L, Matys J, et al. Photobiomodulation—underlying mechanism and clinical applications. J Clin Med. 2020;9:1–17.
Marco, F.D.; Romeo, S.; Nandasena, C.; Purushothuman, S.; et al. The time course of action of two neuroprotectants, dietary saffron and photobiomodulation, assessed in the rat retina. Am. J. Neurodegener. Dis. 2013, 2, 208–220.
Begum, R.; Powner, M.B.; Hudson, N.; Hogg, C.; Jeffery, G. Treatment with 670 nm light up regulates cytochrome C oxidase expression and reduces inflammation in an age-related macular degeneration model. PLoS ONE 2013, 8, e57828.
Chen, T.-W.; Wen, Y.-T.; Liu, P.-K.; Hossen, M.; Tsai, R.-K. Roles of 670 nm Photobiomodulation on Rat Anterior Ischemic Optic Neuropathy: Enhancing RGC Survival, Mitochondrial Function, and Anti-Inflammatory Response. Antioxidants 2025.
Borrelli E. et al. Safety, tolerability, and short-term efficacy of low-level light therapy for dry age-related macular degeneration. Ophthalmology and Therapy, 2024, 13.11: 2855-2868.
Viggiano P. et al. Photobiomodulation-induced choriocapillaris perfusion enhancement and outer retinal remodelling in intermediate age-related macular degeneration: a promising therapeutic approach with short-term results. Eye, 2025, 1-7.
Notes : The eye-light® device is CE-marked as a Class IIA medical device. Availability and regulatory status vary by country.
About Espansione Group
Espansione Group is a recognized pioneer in the medtech industry, focusing on the development of non-invasive treatment and diagnostic technologies built for the betterment of all. The company focuses relentlessly on establishing new paradigms across disciplines, from ophthalmology to dermatology and beyond, driven by its desire to advance regenerative medicine, providing its partners and their patients with the best, certified medical technologies—above all Light Modulation™ Low-level Light Therapy (LM™ LLLT) Photobiomodulation (PBM).
Present in over 50 countries, Espansione Group aims to continue its strong growth in years to come by the means of a constant commitment to research, development, and customer excellence.
Since 2025, Espansione Group is part of EssilorLuxottica.
For more information, visit www.espansionegroup.it
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Posted on June 23rd, 2026 in Newsroom