Novogali Pharma Reports Positive Results in Phase II Study Comparing Treatment With Catioprost® vs. Travatan Z® in Glaucoma Patients
September 13, 2011
Novagali Pharma announced positive phase II positive results last week on the efficacy and safety of Catioprost® in patients with glaucoma and presenting concomitant ocular surface disease (OSD). The study met its objectives demonstrating intraocular pressure (IOP) reduction and OSD signs and symptoms improvement compared to Travatan Z® control group.
The multicenter, phase II, investigator-masked, randomized study was designed to evaluate the safety and efficacy of Catioprost® compared to Travatan Z® (manufactured by Alcon), both BAK-free prostaglandin analogue products, in subjects with glaucoma or ocular hypertension and OSD. Efficacy endpoints were the reduction of IOP and improvement in signs and symptoms of OSD including corneal fluorescein staining (CFS) and conjunctival hyperemia (eye redness). 105 patients were enrolled and results were evaluated after one month and three months of treatment.
Catioprost® was shown to be as effective as Travatan Z® in lowering IOP. At month three, the mean of diurnal IOP reduction from baseline was 29% vs 24% at 8am, 29% vs 27% at 10am, 26% vs 24% at 4pm respectively for Catioprost® vs. Travatan Z®.
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