In November 2007, just prior to that year’s AAO meeting, I learned about a new laser that had the potential to alleviate the early stages of age-related macular degeneration and other retinal diseases including diabetic maculopathy, caused by compromised Bruch’s membrane. The laser-based therapy was called ELLEX’s 2RT (Retinal Regeneration Therapy).
The theory behind the therapy was based on research conducted by Professor John Marshall at St. Thomas’ Hospital of London, and his colleague Dr. Ali Hussain. They found, after experimentation, that a specially-built Q-switched doubled YAG laser (532 nm) operating at 3 ns pulses, could be used subthermally to trigger a renewal process of the retinal pigment epithelial (RPE) cells, a sort of biostimulation, without damaging the overlying retina, including photoreceptors. This caused the RPE to migrate and release matrix metalloproteinases, enzymes, which act to clean up Bruchs membrane. The scientists were able to demonstrate and measure Bruch’s ability to transport water and chemicals and thus rejuvenate the retina.
For the rest of the story, please see my complete initial report of November 2007. (Link at the end of this post.)
First Clinical Results
In November 2008, Ellex released the six-month clinical study results of the first trial. In this clinical study, conducted at St. Thomas’ Hospital in London by Professor John Marshall, 23 patients (38 eyes) with newly-diagnosed diabetic maculopathy and/or macular edema were recruited and treated with Ellex 2RT. Seventeen patients (28 eyes) completed the six-month follow-up examination.
Patients are being followed for one year. Postoperative testing includes optical coherence tomography and microperimetry.
At the six-month follow-up, for the17 patients (28 eyes), the LogMar visual acuity had improved by two or more lines in 43% of eyes and between one and two lines in 28%. It remained unchanged in 15% of eyes, and deteriorated by two or more lines in 14%. Central macular thickness decreased by more than 5% from baseline in 46% of patients, remained stable in 39%, and had an increase of more than 5% in 15% of patients. The number of hard exudates decreased in 41% of eyes, stayed stable in 43%, and increased in 16%. Vascular leakage decreased in 55% of eyes, was unchanged in 31%, and increased in 14%. Slit-lamp ophthalmoscope microperimetry confirmed that photoreceptor function was not affected by the laser treatment. No adverse effects occurred during the study period.
The six-month results show that Ellex 2RT is clinically safe and effective in the treatment of macular edema secondary to diabetic retinopathy.
An example of the minimal damage to retinal cells is shown in the following illustration of 2RT treated Porcine RPE:
Research Program Update (April 2010)
Since the release of preliminary clinical results in 2007 and of the six-month results in 2008, Ellex has initiated a series of pilot clinical studies aimed at evaluating the clinical efficacy of Ellex 2RT for a number of indications, the most important of which is age-related macular degeneration (AMD). The studies are making good progress, with eight prototype systems currently in use throughout Australia and the United Kingdom in these studies. Patient recruitment is nearing completion in two of the key pilot studies, with follow-up planned over a 12-month period.
Studies focused on diabetic macula edema (DME) and proliferative diabetic retinopathy (PDR) are being undertaken in collaboration with the Royal Adelaide Hospital at three study sites. A major benefit of these studies is that they include control groups, allowing Ellex to more accurately benchmark the effect of Ellex 2RT treatment against conventional laser treatment.
A third study, focused on early AMD treatment, is being undertaken in collaboration with the Royal Victorian Eye and Ear Hospital, a major Australian teaching institution, under Professor R. Guymer.
Ellex will present preliminary results from these studies at the 2010 ARVO meeting in May. Once the results from this round of pilot studies have been fully analyzed, the company will evaluate the opportunity to undertake a multi-center randomized study, and look to expand their study sites beyond Australia and the UK.
In addition, as announced earlier this month, Ellex has sublicensed the SRT (selective retinal therapy) patent, U.S. 5,549, 596, from Massachusetts General Hospital, and can now enter the U.S. market with this technology.
(For more information on this development, please see my report: AMD Update 8: Breaking News – Ellex Sublicenses SRT Patent, linked at the end of this report.)