Dry Eye Para-Inflammation Management: Preclinical and Clinical Evidence on a Novel 0.2% Hyaluronic Acid-Based Tear Substitute with 0.001% Hydrocortisone Sodium Phosphate.

Abstract

Purpose: An innovative eyedrop formulation based on a combination of 0.2% hyaluronic acid and 0.001% hydrocortisone sodium phosphate (Idroflog®, Alfa Intes, Italy; HAC eyedrops) was granted a European Patent in 2016 and has been available on the market since 2019 in Europe and in other countries around the world. HAC eyedrops aim to synergize the moisturizing effects of hyaluronic acid with the mild anti-inflammatory properties of low-dose hydrocortisone, offering a more effective and safer alternative for treating dry eye disease (DED), targeting both tear film instability and dysfunctional para-inflammation. The activity of HAC eyedrops has been explored in different post-marketing clinical trials, in addition to preclinical studies. In this narrative review, we explored the available evidence on the use of HAC eyedrops for the management of para-inflammation in DED patients to provide a comprehensive overview of efficacy and safety data related to the use of this medical device in routine clinical practice. Methods: A literature search for preclinical and clinical data involving treatment with HAC eyedrops was conducted using PubMed/MEDLINE, considering only original research articles published in English, without time restrictions. Results: One preclinical and four clinical papers were retrieved. Preclinical evidence suggests that 0.001% hydrocortisone is able to control the expression of inflammatory markers, and this, together with the hydrating and lubricating properties of hyaluronic acid, leads to improvements in DED clinical signs, such as tear volume and the stability of the tear film. The results of clinical trials demonstrate that HAC eyedrops are able to improve the signs and symptoms of DED and that 0.001% low-dosage hydrocortisone can be helpful in preventing the progression to chronic stages of DED. Conclusions: HAC eyedrops represent a promising therapeutic strategy for the management of dysfunctional para-inflammation and offer a valuable addition to the armamentarium of treatments for DED.