The drug, which has the potential to treat and prevent the disease, should reach the population in the coming years
Currently, 13 million Brazilians live with diabetes, a number that represents 6,9% of the country's population, according to data from the Brazilian Diabetes Society. One of the complications of the disease is the so-called diabetic retinopathy, which can compromise patients' vision and, in more advanced stages, lead to total and irreversible vision loss. The condition is a consequence of neural and vascular changes in the retina, caused by the effect of high glycemic levels (serum glucose). But, if on the one hand there is the disease and its challenges, on the other, researchers from the Faculty of Chemical Engineering (FEQ) and the Faculty of Medical Sciences (FCM) at Unicamp may have the solution: an eye drop that treats and prevents the disease. The technology should reach the population in the coming years.
Currently, it is possible to find other therapeutic options for the disease, such as laser photocoagulation, intravitreal injections and even surgery. However, unlike the pharmaceutical composition obtained at the University, all of these methods are invasive, as highlighted by researcher Jacqueline Mendonça Lopes de Faria, responsible for the studies. “The pharmaceutical formulation contained in the eye drops permeates the ocular barriers, carrying the active ingredient to the retina. The eye drops we developed, as they are topical, do not pose any risks to the patient”, says the researcher, who left her role at Unicamp to create SIGHT, the R&D arm of M. Lopes De Faria Oftamologistas Associados, a company she licensed, last year and on a non-exclusive basis, technology.
Widely reported in local and national newspapers and news programs, in 2016, the technology aroused the interest of the population and pharmaceutical companies and laboratories. The technology, which also recently won the Empreenda Saúde Award, is a clear example of how investment in research is capable of generating benefits for society.
However, Jacqueline highlights that composition is still an embryonic technology and requires technological development
complementary until it actually becomes a product and can be used on a large scale. “Although several large companies in the pharmaceutical industry have shown interest in the technology, the development of new eye drops is still early and depends on new research by the inventors”, assesses Jacqueline.
And that's when the idea of licensing for his own company came about. “The idea is that, after new research and technological development, large pharmaceutical companies will carry out clinical tests on humans and commercialize the eye drops”, he adds. In other words, M. Lopes De Faria will operate in the B2B, Business to Business model, providing the technology so that another company can commercialize it and take it to patients. “Our client is the company and not the end consumer”, she highlights.
The expectation is that the eye drops can be used in patients – both in the prevention and treatment of diabetic retinopathy – in the coming years. However, there is still a long way to go, as the researcher and entrepreneur reminds us. “We need resources to carry out safety tests here in Brazil and abroad and then put together a dossier that will be sent to regulatory bodies to begin the testing phases, which range from safety to efficiency”, highlights Jacqueline.
One of the challenges of research is larger-scale production for the pharmaceutical industry. “Research must converge on the use of raw materials with a high degree of purity, product stability, scaling of production for testing on a larger population of animals and, later, on humans”, adds professor Maria Helena Andrade Santana, from FEQ , and who also participated in the development of the composition.
It is worth remembering that the use of the technology has already been tested on experimentally diabetic laboratory rats, obtaining promising results. The composition also proved to be efficient in promoting protective effects on the functional retina. In the study in vivo conducted at Unicamp, no adverse side effects were observed. “In the experiments, the use of eye drops enabled important neuroprotective effects on the retina in diabetic animals, which we were able to observe through the electroretinogram”, corroborates Jacqueline.
The person responsible for developing the composition also highlights the potential for using the eye drops to treat and prevent other eye diseases. In other words, it is a highly promising pharmaceutical formulation for ophthalmology. “The use of eye drops facilitates the administration of the drug, without the risks of an intraocular procedure or the irreversible damage of laser photocoagulation to the patient's retina”, she assesses.
Doctor Mariana Aparecida Brunini Rosales and Aline Borelli Alonso, a master's student in Chemical Engineering, also worked on the development of the pharmaceutical formulation. The studies were supported by the São Paulo State Research Support Foundation (Fapesp) and the Coordination for the Improvement of Higher Education Personnel (Capes).
