Ophthalmos Research and Educational Institute (OREI) announced positive clinical and highly statistically significant topline results from its prospective, randomised, double-blind multicentre study in Europe, to assess the potential effects of omega 3 fatty acids supplementation (Eyetas) in moderate to severe Dry Macular Degeneration and Stargardt Disease (MADEOS study – NCT03297515 )
The test product included 4 capsules per day of omega 3 fatty acids (Eyetas) and the placebo contained sunflower oil.
Twenty-one eyes of 21 patients were included in the analysis according to the inclusion criteria (active : placebo, 2:1). However, this enrolment did not meet the original goal of 60 eyes because of the COVID -19 pandemic.
At 6 months, in the active group the mean ETDRS BCVA had an increase from 40.93 to 46.93 letters i.e mean number of 6 letters increase (p<0.05). The placebo group had a mean loss of -0.14 letters. This difference of 6 letters between the active and the placebo group was statistically significant (p<0.05).
There was no statically difference between the starting BCVA between the 2 groups.
57% of the eyes in the active group gained 5 or more letters compared to none in the placebo group (p<0.05).
The blood AA/EPA (arachidonic acid/eicosapentaenoic acid) decreased in the active group, from 5.84 at screening to 1.47 at 6 months, as opposed to the placebo group where the ratio remained at the same level from 5.67 at screening to 5.37 at 6 months. The difference between the 2 groups at 6 months was statistically significant (p<0.05).
‘Eyetas provided significant improvement in BCVA from baseline to 6 months in moderate to severe dry AMD and Stargardt disease’ stated Dr Tassos Georgiou, who is a Vitreo-Retinal Surgeon at OREI and the CEO of Eyetas Therapeutics. The results support the conclusion of our preclinical studies on Dry AMD and Stargardt disease animal models and of our observational studies from patients in our Institute. But most important, the dosing levels of omega 3 fatty acids and the EPA/DHA ratio necessary to attain these benefits were determined. These clinical data suggest that even in severe , chronic degenerative diseases, oral supplementation of Eyetas can reverse vision loss. This is the first study to show reversal of vision loss in moderate and severe Dry AMD and Stargardt disease which is clinically significant compared to placebo.’
‘Having an oral supplement that could restore vision would have a positive impact on the quality of life of these patients. Many patients can also be removed from the blind registration list, with lots of savings to the health systems. Another advantage of oral supplementation, is that it can have an effect in both eyes without any ocular side effects.’
We would like to thank the European Vision Institute of Clinical Research for coordinating the clinical study. Also the patients and the clinical sites for their participation.
The full study results will be published in the near future.
Visit the Company’s website : www.eyetas.com