Novartis has shelved Xiidra in Europe after the European Medicines Agency (EMA) said its effectiveness in treating dry eye disease (DED) had not been demonstrated effectively.

Novartis bought the DED prescription eye drop from Takeda Pharmaceutical last year for US$5.3 billion, including $3.4 billion upfront and $1.9 billion in milestone payments, three years after the drop was approved by the US Food and Drug Administration (FDA).

“Although some effect was seen in the reduction of eye dryness, the improvement was not considered clinically significant,” said the EMA, noting there was also no long-term data on Xiidra despite DED being a chronic disease. The clinical data for Xiidra was further criticised for only being compared with a placebo, rather than other eye drop treatments.

Novartis confirmed it was voluntarily withdrawing its European marketing application as, “the majority of objections raised cannot be resolved within the available time frame.” It reserved the right to make further submissions in the future but confirmed there were currently no ongoing trials for Xiidra.