Following the news that Alcon has set its sights on acquiring Lumithera and, with this acquisition, the associated rights to the Valeda Light Delivery System, LumiThera’s photobiomodulation (PBM) device aimed at treating dry age-related macular degeneration (AMD), it seems only fitting we take a look at the history of PBM and how it came to be used in ophthalmology.
PBM – or “Low-level light therapy (LLLT)” – treatment was first discovered in 1967 by Hungarian physician, Endre Mester, only seven years after the invention of the ruby laser (in 1960) and six years after the invention of the helium–neon (HeNe) laser (in 1961). At the time, Mester was actually studying how high-powered lasers might be used to reduce tumors in murine models when, unbeknownst to him, he mistakenly used a faulty, less powerful laser for his experiments. This technical mishap led to Mester accidentally discovering that, while the low-powered ruby laser did nothing for the tumors he was hoping to treat, it did seem to stimulate hair regrowth and wound healing in the shaven mice he was examining.
While LLLT (originally called "laser biostimulation'" by Mester) was initially used to treat skin ulcers in his native Hungary, it gradually became a recognised physical therapy modality, making inroads into China, the Soviet Union, and Eastern Europe in the 1970s. The therapy – thought to relieve pain and enhance cell function, as well as stimulating healing – eventually broadened its scope in the early 2000s, when researchers – witnessing reduced retinal inflammation and oxidative stress in animal studies – began to explore using LLLT for retinal diseases, specifically age-related macular degeneration (AMD) and diabetic macular edema (DME).
In the present day, LLLT – mostly referred to under the more modern, scientific designation of Photobiomodulation (PBM) within the healthcare industry – is now being used by a number of ophthalmology companies seeking to optimize the protective (and potentially restorative) effects of the treatment. This includes the aforementioned Alcon and Lumithera, but also companies such as the Italian-based Espansione Group, which has developed a wearable eye-light device, which obtained its CE mark for dry AMD and a range of other retinal and corneal conditions just last year.
While PBM is no longer regarded as a fringe therapy in ophthalmology, it is still considered as lying somewhat on the outskirts of other modern treatments for AMD, with AREDS 2 supplements and lifestyle changes still being advised for early and intermediate dry AMD, and complement inhibitors Pegcetacoplan (Syfovre) and Avacincaptad pegol (Izervay) continuing to be the mainstay treatment for GA.
Alcon’s Lumithera acquisition, however, does mark an important milestone in photobiomodulation development, potentially signaling a step towards broader mainstream adoption of the treatment. It’s also no coincidence that Lumithera’s Valeda® Light Delivery System was authorized by the FDA for use in the treatment of dry AMD only seven months before the acquisition, marking it as the first non-invasive therapy to be approved for treating this condition. In this same month the device also received its CE mark in Europe, allowing it to be used across the EU for the treatment of dry AMD, as well as being available – through a distribution agreement with medical equipment company, Andrec Corporation S.A – in various Latin American countries, such as Colombia, Chile, Bolivia, and Venezuela.
With 23 manufacturing and distribution facilities across 17 countries, Alcon does already have the capacity to introduce these PBM devices to a global market. It’s now just a question of whether these other countries will follow suit with the US, EU and Latin America, and approve the low-level light treatment Mester accidentally discovered all those years ago.
