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FOR RELEASE 3/6/2013, Wednesday

Presentation of the Phase 2b Results for Glaucoma Drug Candidate Latanoprostene Bunod

The phase 2b results for latanoprostene bunod (previously known as BOL-303259-X) were presented at the American Glaucoma Society 23rd Annual Meeting on March 2 by Robert N. Weinreb, M.D., chairman & distinguished professor of Ophthalmology, University of California San Diego and director, Shiley Eye Center and Hamilton Glaucoma Center.

Latanoprostene bunod, a nitric oxide-donating prostaglandin F2 alpha analog licensed by Nicox to Bausch + Lomb, is being developed for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. In this dose ranging study, it was shown that latanoprostene bunod consistently lowered IOP in a dose-dependent manner.

Glaucoma is a group of eye diseases which can lead to the loss of peripheral vision and eventually total blindness. Glaucoma is frequently linked to abnormally high pressure in the eye (intraocular pressure, IOP), due to blockage or malfunction of the eye’s drainage system. Several large trials have demonstrated that reducing IOP can prevent the progression of glaucoma in both early and late stages of the disease. A significant proportion of patients with elevated IOP require more than one medication to maintain their IOP within target levels, highlighting the need for more effective treatments.

The presentation showed that latanoprostene bunod is effective at lowering IOP at multiple concentrations in a dose-dependent manner. It also showed that latanoprostene bunod 0.024 percent QD statistically significantly reduced IOP greater than latanoprost with a similar side effect profile.

The randomized, investigator-masked phase 2b study was initiated by Bausch + Lomb in November 2010 to identify the most efficacious and safe dose of latanoprostene bunod for the reduction of IOP. The study enrolled 413 patients across 23 sites in the United States and Europe. Patients were randomized to receive either latanoprostene bunod (various concentrations) or Xalatan® 0.005 percent (latanoprost) once a day in the evening for 28 days. The phase 2b study met its primary efficacy endpoint which was the reduction in mean diurnal intraocular pressure (IOP) on day 28 and showed positive results on a number of secondary endpoints.

In light of the positive results of the phase 2b results, Bausch + Lomb initiated a phase 3 clinical program of latanoprostene bunod in January 2013. The program includes two separate randomized, multicentre, double-masked, parallel-group clinical studies, APOLLO and LUNAR, designed to compare the efficacy and safety of latanoprostene bunod administered once daily (QD) with timolol maleate 0.5 percent administered twice daily (BID) in lowering IOP in patients with open-angle glaucoma or ocular hypertension.

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