Bausch + Lomb Announces Publication Of Results On LBN Ophthalmic Solution

(RTTNews) - Valeant Pharmaceuticals International Inc.'s (VRX, VRX.TO) wholly owned subsidiary, Bausch + Lomb and Nicox S.A. announced that the results of a Phase 3 study for latanoprostene bunod or LBN ophthalmic solution 0.024% have been published in the American Journal of Ophthalmology.

LBN 0.024% is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily for patients with open angle glaucoma (OAG) or ocular hypertension or OHT.

The results of this study, called LUNAR, demonstrated that LBN 0.024% administered once daily (QD) in the evening was not only non-inferior to timolol maleate 0.5% dosed twice daily (BID) in subjects with OAG or OHT over 3 months of treatment, but also provided significantly greater IOP reduction (P=0.025) at all but the earliest time point evaluated.

Adverse events, though uncommon, were slightly higher in the LBN group. They included conjunctival hyperemia, eye irritation, and eye pain and were mostly mild-to-moderate in severit.

A second similarly designed study, published in the May issue of Ophthalmology, also demonstrated the efficacy of LBN 0.024% for IOP lowering. In this randomized, controlled, multicenter, double-masked, parallel-group, non-inferiority clinical study, called APOLLO, the primary efficacy end point was IOP in the study eye measured at the same 9 assessment time points as LUNAR. Results showed that the mean IOP in the study eye was significantly lower in the LBN 0.024% group (range, 17.8-18.7 mm Hg) than in the timolol 0.5% group (range, 19.1-19.8 mm Hg) at all 9 efficacy time points assessed.