Periodic Reporting for period 1 - RetinDR (RetinDR: The first topical ophthalmic formulation (eye drops) that effectively prevents and/or treats the retinal neurodegeneration induced by diabetes (diabetic retinopathy) and/or aging) Periodo di rendicontazione: 2019-08-01 al 2020-01-31 Sintesi del contesto e degli obiettivi generali del progetto Diabetic retinopathy (DR) is the leading cause of blindness among working-aged adults. About 110 million people worldwide and 3%-4.1% of Europeans suffer this disease. The early stages of DR usually have no symptoms, however when the disease progresses it affects vision. Ophthalmologist can detect the beginning of DR, however there are no treatments for this stage of the disease, the only treatments available are quite aggressive (intravitreal injections, retinal laser photocoagulation, vitrectomy), and for this reason are only indicated in advanced stages of the disease. RetinDR is an eye drop formulation to treat early stages of Diabetic Retinopathy that is able to stop and regress the progression diabetic retinopathy. Therefore, RetinDR is a breakthrough for early stage DR that offers for the first time an easy effective solution for over 110 Mill patients with DR and no solution today. There is an unmet clinical need and Retinset is bringing to the society a treatment to a global disease with an increasing incidence, causing significant socio-economic impact. With RetinDR we will improve the quality of life of patients, and will help to reduce the social and health costs of this harmful complication of diabetes. The overall objectives of the project are: - Demonstration of the market viability: Quantify the level of market demand and willingness to pay by main users. Analysis of the risks and potential entry barriers due to acceptance and regulation.- Clinical evaluation of the safety of RetinDR in Type 2 diabetic patients in a national multicentre study. - Updating the business plan accordingly. Plot the business model, route to market, market penetration, marketing strategy, inception and commercialization for RetinDR. Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti Thanks to the funding received with this European grant SME1, we have been able to achieve the strategic objectives proposed at the beginning of the project:Start the execution of the phase 1 clinical trial: We have initiated a safety study of the eye drop formulation (phase 1 clinical trial). Today there are 3 patients who had been administered RetinDR, are results are very satisfactory.Market study: This allowed us to deepen the knowledge of our market, meet the main players, and identification of future competitors, and technologies. Business Plan: The process of preparing a comprehensive business plan helped us to gain greater knowledge of our business ideas. The discipline of the planning process helped us to evaluate the opportunity and allowed us to shape a business model to exploit it.In addition, we have been able to carry out several activities that have proved to be fundamental to give external visibility to our company: the launch of our website, and attending one of the biggest partnering events in Europe: Bio-Europe fall 2019. The feedback received has been very important to know first-hand what investors and scientific community need to know about RetinDR, and to better define our company strategies to the growth of the company. Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora) RetinDR is addressed to the ophthalmic pharmaceutical sector and specifically to the market related to retinal disorders, to be used for the treatment of diabetic patients with early stage DR. As previously mentioned, this a treatment with a big impact in the society and with competitive advantages in the market. The long term consequences of DR such as visual impairment increases the risk for unemployment, depression and anxiety disorders as well as number of falls and accidents. It leads to reduced independence and quality of life of affected individuals. The treatment of DR at early stage will reduce the number of blind and severely visually impaired patients, and will decrease the economic expense that this disease entails Retinset solution
