Eye diseases such as age-related macular degeneration (AMD) are expected to increase in coming years due to a variety of factors, including an aging population, unhealthy lifestyle and increased risk of chronic inflammatory diseases.

AMD is the leading cause of vision loss in individuals over the age of 55 in industrialized countries.

The World Health Organization (WHO) estimates that by 2030, the number of patients with AMD will reach 243.4 million, a 24% increase compared to 2020.

Numerous risk factors for AMD have been identified including: ethnicity, sex, smoking, alcohol consumption, hyperlipidemia, hypertension, cardiovascular diseases, obesity, exposure to visible or ultraviolet radiation and nutritional deficiencies.

However, growing evidence indicates that AMD is a downstream condition of a chronic inflammatory state in which the activation of the immune system plays an important role. Thus, in the pathogenesis process of macular degeneration, it’s essential to counteract not only oxidative stress, as shown by the first AREDS study, but also chronic inflammation, as it could contribute to wet AMD.

Thus, scientific progress should aim at contrasting the effects of oxidative stress and chronic inflammation, withdirect intervention at the origin of both causes of AMD.

Currently there is no specific treatment for dry AMD, apart from raising awareness of preventive measures to avoid disease progression. Among these, the intake of natural antioxidant substances contained in supplements with AREDS and AREDS 2 formulations are recommended.

Many studies suggest that the pathogenesis of AMD is related to the dysfunction of the Retinal Pigment Epithelium (RPE). The RPE performs metabolic functions that are critical for the survival of retinal photoreceptors, including phagocytosis and degradation of the external segments of the photoreceptors.

The reduction of the RPE phagocytosis activity plays a fundamental role in the pathogenesis of retinal diseases, causing an accumulation of lipofuscin in the lysosomes as evidenced by the drusen formation during patient examination. The quantity and size of drusen is an indication of AMD progression.

The activation of the retinal microglia is involved in neovascular AMD, as it increases production of pro-inflammatory substances and of pro-angiogenic VEGF.

PPARγ is an intracellular receptor and transcription factor that regulates unsaturated fatty acid storage and glucose metabolism. PPARγ binds prostaglandins and leukotrienes.

PPARγ signaling can reduce the inflammatory process.

A turmeric-phytosome (MERIVA®), one of Eye Pharma’s iPhytoone®, is a PPARγ  . This product is capable of regulating the natural inflammatory response to prevent it from developing into chronic inflammation, which may contribute to retinal changes, such as drusen formation and hyperpigmentation.

 

BASED ON THESE PREMISES, A PILOT STUDY WAS INITIATED TO TEST MERIVA® IN AMD, WITH THE AIM OF IDENTIFYING THE IDEAL SAMPLE SIZE FOR A FUTURE LARGER STUDY.

In this pilot study, subjects over the age of 50 demonstrating the presence of drusen of any size in one or both eyes were enrolled.

Subjects with ocular changes that could influence the evaluation of drusen, subjects with signs of choroidal neovascularization (CNV) in both eyes, subjects with systemic pathologies that could interfere with the absor