Phase 3 Study of Non-Preserved Latanoprost for Glaucoma
Clermont Pharmaceuticals announced positive results from its Phase 3 study of non-preserved latanoprost for the treatment of glaucoma. In the study, non-preserved latanoprost was compared to Xalatan (latanoprost ophthalmic solution; Pfizer) 0.005% in subjects diagnosed with open-angle glaucoma. Non-preserved latanoprost achieved the primary efficacy endpoint of non-inferiority to Xalatan. In addition, non-preserved latanoprost was better tolerated than Xalatan, with statistically fewer ocular symptoms on instillation and significantly fewer subjects with conjunctival hyperemia. Based on these positive results, Clermont intends to file a new drug application with the FDA in the fourth quarter of 2011.
Xalatan is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Clermont Pharmaceuticals is a privately held Florida based ophthalmic pharmaceutical company focused on the development of new medicines for the treatment glaucoma.