Dry eye syndrome (DES) is a commonly occurring condition that affects the quality of life of afflicted individuals due to ocular discomfort and visual disability. Despite the fact that signs and symptoms of the disease have been known for a relatively long time compared to other diseases, current treatment options for patients with DES are limited.
Artificial tears are the most commonly recommended treatment option for milder forms of DES. More severe cases are usually prescribed anti-inflammatory therapies such as cyclosporines, usually in combination with a short-term corticosteroid therapy for relief of symptoms. Due to a number of promising therapies that are currently in pipeline development for DES, GlobalData expects that there will be a significant change in the available treatment options for DES over the next 10 years.
According to GlobalData’s Intelligence Centre, there are 52 pipeline products in different stages of development across the nine major markets (US, France, Germany, Italy, Spain, UK, Japan, China, and India). That is a significant number of pipeline products for DES, considering that the currently available treatment options such as Allergan’s Restasis (cyclosporine 0.05%) and Novartis’ Xiidra (lifitegrast) principally impart an anti-inflammatory response to alleviate symptoms along with corticosteroids and artificial tears.
16 of these pipeline products are currently in Phase III development. From a drug class perspective, four variations of cyclosporine are currently in late-stage development.
Key opinion leaders (KOLs) interviewed by GlobalData were generally positive about these formulations, particularly about whether any of them were able to offer a better tolerability profile compared to currently marketed cyclosporine formulations. Among the remaining pipeline products, KOLs indicated that the most promising mechanisms of action (MOAs) include therapies that are able to improve corneal wound healing, improve the function of meibomian glands and inhibit the formation of toxic metabolites.
Most KOLs interviewed by GlobalData indicated that one of the major unmet needs within DES is the need for therapies with new MOAs. GlobalData anticipates that some of these pipeline products, if not all, will be able to address this major need.
For example, RegeneRx Biopharmaceuticals’ RGN-259 is proposed to improve corneal wound healing by the down-regulation of pro-inflammatory cytokines and Novaliq’s NOV03 is understood to improve the function of the meibomian gland. Mechanistically, these are promising profiles, and GlobalData expects that results from Phase III clinical trials evaluating the products may be able to demonstrate their superior efficacy in DES patients compared to currently available treatments. If that is the case, some of these companies could become targets for acquisition by larger pharmaceutical companies.