Nicox’s NCX 470 Hits Phase III Endpoint In Glaucoma But Misses Superiority

NCX 470 demonstrates non-inferiority in intraocular pressure reduction versus latanoprost in the first of two Phase III studies, but does not meet a secondary endpoint that would have shown superiority.

Glaucoma model
Nicox is looking to enter the very competitive glaucoma therapeutic space • Source: Shutterstock

Nicox S.A. posted mostly favorable Phase III data from the first of two pivotal trials for its glaucoma/ocular hypertension eye drop NCX 470, but missed demonstrating superiority versus a comparator that could have positioned the candidate to become a new standard of care.

The French company revealed on 31 October that NCX 470 – a formulation of the prostaglandin analog bimatoprost, the active ingredient in AbbVie Inc.’s Lumigan, paired with nitric oxide-donating technology – met the primary endpoint in the 691-patient Phase III Mont Blanc study for non-inferiority to comparator latanoprost in reducing intraocular pressure (IOP) from baseline. A 0.1% dose of NCX 470 reduced IOP by 8.0-9

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