Following Novartis’ acquisition of Takeda’s dry eye drug Xiidra, Alessio Brunello, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his view on the first and only prescription treatment approved by the FDA to treat signs and symptoms of dry eye syndrome (DES):

“The deal will extend Novartis’ ophthalmology portfolio showing its commitment to be an ophthalmology player after the spin-off of its eye disease device unit, Alcon, earlier this year. But the market for Xiidra could face a few challenges as generic versions of its main rival, Allergan’s Restasis, are available due to patent loss protection in May 2019. However, Restasis targets just the sign of the disease and not the symptoms giving Xiidra a competitive advantage.

“Xiidra, on the other hand, is the first-in-class therapy for both signs and symptoms of DES. It targets inflammation and acts on a distinct inflammatory pathway, displaying quicker onset of action and different side effects than Allergan’s Restasis. GlobalData forecasts Xiidra to generate global sales of US$1.2bn by 2025. 

“Before the approval of Xiidra in 2016, the FDA stipulated that DES drugs needed to show statistical improvements in both a sign and a symptom of DES to be considered for marketing approval. The inconsistency between signs and symptoms has long presented a severe challenge to achieving approval in the US. Xiidra is approved by FDA in the US and currently in pre-registration in Europe.”