While the Phase IIb Mississippi study in patients with acute exacerbations of blepharitis did not meet the primary endpoints in that indication, a post-hoc analysis showed potentially promising data that NCX-4251 could provide clinical benefit in patients with dry eye disease (DED), a c $5bn market. Given that blepharitis is commonly associated with DED, of the 224 enrolled patients, 123 were found to have inferior corneal staining (by a score of at least two on a five-point scale), a key sign of DED. Among these 123 patients, there was a statistically significant difference versus placebo in the change from baseline in eye dryness scores (assessed on a validated Visual Analog Scale). Significant differences were also observed in other DED symptoms (including photophobia, blurred vision, burning/stinging, pain and others) at all measured time points in the 14-day treatment, and for some, the effects persisted for up to two weeks after the end of treatment. The company plans to meet the FDA in early 2022 to discuss a potential alternate development path for NCX-4251.Den vollständigen Artikel lesen ...
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