Clark E. Tedford, PhD, is a co-founder of LumiThera Inc. based in Poulsbo, Wash., and has served as president and CEO since the formation of the company in 2013. LumiThera develops treatment solutions to improve visual function, stop or slow the progression of debilitating eye diseases and prevent vision loss and blindness. The Valeda Light Delivery System is the first approved treatment for dry AMD using photobiomodulation in the European Union and is currently in clinical trials in the United States.

Ophthalmology Management: Can you discuss the Valeda Light Delivery System, how it works and its benefits?

Clark E. Tedford: The goal of LumiThera is to address some of the largest unmet medical needs, like dry AMD. The Valeda Light Delivery System uses photobiomodulation (PBM), which harnesses the power of light to target disease at the cellular level. Valeda delivers select wavelengths, which act on cellular mechanisms important to AMD. PBM activates photoacceptors in the mitochondrial respiratory chain. The specific wavelengths of PBM treatment increase enzymatic activity at two separate sites on cytochrome c oxidase (CCO). Increased CCO activity helps drive the generation of the proton radiant required by adenosine triphosphate (ATP) synthase to produce energy. Restoring the production of energy, ATP and signaling molecules triggers secondary effects that sustain improved cell function.

PBM treatment has been shown to reduce drusen volume and thickness and increase visual acuity and contrast sensitivity.

OM: What can patients expect with this treatment?

CT: The Valeda Light Delivery System has been tested to show that it meets all industry standards as an eye-safe device. It uses LEDs instead of lasers, which do not focus as the light beam passes through the lens of the eye. The treatment utilizes three distinct wavelengths and takes about 4 minutes per eye. Patients receive nine flexible treatments over 3 to 4 weeks. There’s no pupil dilation, so they can go about their daily activities after treatment as they normally would. The repeat treatments stimulate the cells — resetting the patient’s metabolic activity — giving patients sustained benefits.

Clinical outcomes have shown improvement in overall vision in patients who were treated with Valeda — PBM treatment may increase blood flow and energy production. Patients have also reported that colors are brighter, they can read more letters on the eye chart, can read better in low levels of light, and that blurred vision is better.

Not only are we enriching the quality of life for these patients, but we’re potentially slowing the progression by seeing benefits in the underlying pathology.

OM: When will it be available in the United States?

CT: The LIGHTSITE III dry AMD trial, the pivotal US trial, completed enrollment with 100 patients in the first quarter of 2021 and is an FDA-approved study to support approval in the United States. All of the patients have passed their 13-month time point, and that’s the initial efficacy readout. By the end of the first quarter of 2022, we’ll be able to take a look to see if there’s benefit.

If everything goes well, we could be submitting to the FDA for a potential approval by the fourth quarter of 2022.

OM: LumiThera completed the acquisition of Diopsys Inc. in March 2022, creating a light-based theranostic company. Can you expand upon this acquisition and plans?

CT: With this acquisition, Diopsys Inc., a manufacturer of visual electrophysiology medical devices, became a wholly owned subsidiary of LumiThera. Diopsys electroretinography (ERG) testing will provide a complementary diagnosis and monitoring platform to LumiThera’s Valeda Light Delivery System.

The ERG device is a functional vision testing system and established diagnostic tool for many eye diseases. The larger combined company provides the tools for doctors to diagnose, treat and monitor degenerative eye disease.

Diopsys also brings an established commercial US sales force and, when combined with LumiThera, will create a larger global footprint with a significant ophthalmology/optometry customer base as our company approaches the US market. OM