How would you summarize what your startup does in a brief way?
The X-eLUT concept represents the first non-invasive treatment of age-related degenerative eye diseases. We are talking about an innovative pharmaceutical product capable of effectively and safely restoring ocular levels of lutein, a bioactive compound essential for protecting the functionality of cell structures involved in the vision process. Such a unique treatment would prevent the prevention and progression of some of the most widespread degenerative eye diseases in the adult population, in particular those over 50 years old, such as cataracts and age-related macular degeneration
What is unique about your product?
Constant exposure of the eye to the negative impact of various sources of natural or artificial light (e.g. phone screens, laptops, etc.), coupled with the effects of eye ageing, significantly increases the risk of developing degenerative eye disease, leading to progressive and irreversible blindness. Unfortunately, these eye diseases are currently not effectively treated or rely exclusively on invasive surgery. Dietary supplementation or oral therapeutics are ineffective in restoring depleted levels of antioxidants to the eye, but applying a stabilized form of lutein topically offers a simple, safe, non-invasive and effective alternative.
In which stage of development is it?
The pharmaceutical product is in an advanced stage of development and has been validated in a pre-clinical setting, in a cataract and diabetic retinopathy animal model respectively. Intensive work is being done on scaling up the manufacturing process and regulatory aspects specific to these pharmaceutical formulations with a view to their earliest possible translation into veterinary therapy (canine cataracts) and the management of human degenerative eye diseases.
Tell us a bit about the team. How important is the diversity of the team for you?
An interdisciplinary approach in the development of such innovative pharmaceuticals is essential. The joint Romanian-American team consists of pharmacists and ophthalmologists, members of the academic community of the University of Medicine and Pharmacy "Iuliu Hațieganu" Cluj-Napoca, and chemical engineers from Louisiana State University, with significant expertise in areas with critical impact in the development of a pharmaceutical product for eye treatments: materials science and nanotechnologies, design/preparation and characterization of advanced pharmaceutical systems with target delivery, testing of product efficacy and evaluation of its clinical effect. However, I would like to highlight the outstanding human qualities of my collaborators, Dr Elena Dinte, Dr Oliviu Voștinaru and Dr Ovidiu Samoilă, who form a close-knit, extremely dynamic and proactive team, which even in the most difficult moments has managed to maintain its optimism and motivation.
What difficulties have you experienced so far?
Scientific innovation is a natural process, much practiced and actively pursued by researchers, which despite all the difficulties is capable of giving you immense professional satisfaction. But science must serve society and not the scientist's curiosity. However, the exploitation of innovative pharmaceutical research through technology transfer to the economic environment brings new challenges and is being carried out in ways that are still not well defined at national level. The difficulties encountered so far have consisted mainly in bureaucratic hurdles, with exhausting and highly demotivating effects, related to the protection and regulation of intellectual property rights in collaboration with our partners at the US university. A change in the mindset of stakeholders, more active support and promotion of those with initiative in this field, identification of the dysfunctionality that causes these bottlenecks, however, could lead to the stimulation of innovative entrepreneurship also in the national medical-pharmaceutical ecosystem.
What went better than you expected?
Although it is hard to imagine, experimental studies have worked best, leading to valuable and very encouraging results for successful translation into therapy.
In the most favorable scenario, how does your startup look like in the next 2 years? What might not work as planned?
The best option for scaling up production is currently being explored, in parallel with the identification of regulatory and registration issues specific to these types of pharmaceuticals. We have learned a lot about scientific entrepreneurship in the Research Valorization Program 2.0 run by the North-West Development Agency within the World Bank's "Supporting Innovation in Romanian Catching Up Regions" project. An important step is our acceptance in the LIF Global 2023 program organized by the Royal School of Engineering in the UK in partnership with UEFISCDI Romania, where we benefit from expert mentoring and entrepreneurial training, access to innovation hubs in London and Oxford, and a series of meetings with potential investors. In order for our initiative to bring more value to the community and for this start-up to materialize and develop in the future, we rely heavily on the support of the University of Medicine and Pharmacy "Iuliu Hațieganu" which has understood the importance of this pillar of academic development and is committed to building a centre of excellence in medical innovation through its own institutional development projects (PROGRES) and through programs of excellence in research and entrepreneurship
What do you require at the moment to accelerate your development?
We are in a continuous process of identifying additional sources of funding to increase the marketability of the developed product
How was the concept born?
Continuing the series of successful experiments on polymeric nanosystems with agri-food applications, and aware of the difficulties faced by clinical ophthalmologists in their current clinical practice in the management of degenerative eye diseases where treatment with antioxidants can bring significant benefits, we initiated a research plan to identify unexplored biointernalization mechanisms and to obtain a lutein-based topical application formula with advanced purity and stability. This will enable us to develop a product tailored to the needs of a category of patients with conditions that, in the absence of effective and affordable treatment, can develop complications such as vision loss, a condition that significantly alters quality of life and has an adverse impact on public health and healthcare budgets.
