In February, the London-based biotech and artificial intelligence (AI) firm initiated a randomized controlled trial (RCT) involving 130 participants with evaporative dry eye disease and Meibomian gland dysfunction.
Primary endpoints include Ocular Surface Disease Index (OSDI), tear break-up time, and the Schirmer test, reflecting both patient-reported symptom burden and objective clinical measures of tear film function and production.
Secondary endpoints include microbiome and metabolomic analyses to understand biological mechanisms alongside clinical outcomes.
This study was designed to build directly on the findings of Enbiosis Biotechnology’s prospective pilot study, which demonstrated meaningful improvements across all primary clinical endpoints.
It aims to establish whether these improvements can be confirmed under more rigorous conditions and in a larger, more diverse patient population.
“The early signals give us strong reason for optimism. The gut-eye axis is an emerging but increasingly well-supported area of research. Our pilot study was not designed as a mechanistic study, but the findings are consistent with the hypothesis that modulating the gut microbiome can influence ocular surface health through systemic pathways,” Dr Ozkan Ufuk Nalbantoglu, chief technology officer at Enbiosis Biotechnology, told NutraIngredients.
Key findings from its pilot study included significant improvements in tear production over the eight-week intervention and continuous improvement through week 16, indicating post-intervention durability.
“A purely symptomatic effect would not be expected to persist and grow after the intervention stops. That pattern points towards a more fundamental biological shift.”
A paired microbiome analysis also showed directional changes consistent with the gut-eye axis hypothesis—reduced Enterobacteriaceae, bacteria associated with systemic inflammation; and increased Coprococcus, anaerobic bacteria associated with short-chain fatty acid production and anti-inflammatory signaling.
The present RCT was designed to explore the gut-eye axis and links with secondary endpoints.
“If the findings hold, this will represent some of the strongest clinical evidence yet for the gut-eye axis as a target in dry eye management. We believe in this science. The early data are promising, and this study represents the next step in building the evidence base the field needs.”
Commercialization deals on the horizon
Enbiosis’s AI-powered platform is built as a digital twin of the gut microbiome—a computational model constructed from human microbiome profiles spanning multiple geographies and populations.
Using genome-scale metabolic modelling, the platform maps the microbial pathways disrupted in a particular health condition and the beneficial compounds that the body is failing to produce in sufficient amounts. From there, its AI retrosynthesis engine identifies the minimal set of food-grade inputs that gut bacteria can convert into the compounds the body needs.
Every ingredient used is based on a defined biological role and not a population-level association or an assumed mechanism, while each formulation is designed to support the gut microbiome in producing its own beneficial compounds, rather than managing symptoms at the surface.
“This is what precision in formulation actually looks like. Rather than selecting ingredients that have shown general benefit in broad population studies, we model the specific biology of a condition across diverse microbiome profiles before a clinical study begins. By the time formulation design is complete, the biological case for every ingredient is already established,” Dr Ozkan said.
Enbiosis is active in nearly 20 countries for its microbiome platform and B2B operations.
“Within six months of completing our dry eye pilot study, we engaged in discussions with more than 30 companies across the ophthalmology, functional food, beverage, and dietary supplement industries worldwide. Interest has been received from leading eye health companies as well as partners across the Asia-Pacific (APAC) region.”
The “Powered by Enbiosis” framework operates through two commercial tracks. The first is formulation licensing, where partners access the formulation logic, technical dossier, and premix ingredients to integrate into their own manufacturing and product lines.
The second is finished products developed directly through Enbiosis’s platform and available for commercialization by brand partners.
“As our clinical evidence base grows, particularly with the ongoing RCT for dry eye, we expect to formalize commercial agreements across APAC in the near term.”
