Nicox glaucoma drug meets endpoints in Phase IIb study
Sophia Antipolis/ Madison – French NicOx S.A. and the global eye health specialist Bausch & Lomb have announced positive top-line results from their phase 2b dose finding study with BOL-303259-X, a nitric oxide-donating version of Pfizer’s prostaglandin F2-alpha analogue latanoprost, in 400 patients with open-angle glaucoma or ocular hypertension. As shown in two previous Phase II trials conducted during NiCox’s partnership with Pfizer, which ran from 2004-2009, BOL-303259-X (previously NCX 116, PF-3187207) was superior to Pfizer’s lipophilic prostaglandin F2-alpha formulation latanoprost (Xalatan®). In 2 of 4 dose regimes, the NO-donating drug lowered intraocular pressure (IOP) better than Xalatan. On top of that, the responder rate was 68.7% for the most efficacious dose of BOL-303259-X, compared to 47.5% for Xalatan®. The most frequent side effect was reddening of the eyes (hyperemia). The results triggered a US-$10m milestone from Bausch & Lomb to its French partner. The US eye specialist announced it will initiate a global phase 3 development program for the eye drops. The firms believe that NO improves the IOP lowering effect of prostaglandin F2-alpha. In two Phase II trials completed in 2008, the drug was reported to be at least 20% more effective than Xalatan®, according to Pfizer, which re-licensed all development and commercialisation rights to NiCox in August 2009 after having refocused its drug development priorities.