Clermont Pharmaceuticals Reports Positive Phase III Results for Drug to Treat Glaucoma
TAMPA, Fla., Sept. 26, 2011 /PRNewswire/ -- Clermont Pharmaceuticals, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today positive results from a phase III trial of non-preserved latanoprost In the study, non-preserved latanoprost was compared to Xalatan® (latanoprost ophthalmic solution) 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. Xalatan is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension; it was approved by the US Food and Drug Administration for use in 1996. Xalatan is the registered trademark of Pfizer, Inc.
Clermont obtained the US rights to non-preserved latanoprost from Laboratoires Thea S.A.S, an ophthalmic pharmaceutical company based in France. Laboratoires Thea recently filed an application for European marketing authorization with the EMEA.
Based on these positive results, Clermont intends to file a New Drug Application with the US FDA in the fourth quarter of 2011. Clermont plans to begin discussions with potential marketing partners in the near future.
About Open-Angle Glaucoma
Open-angle glaucoma is the most common type of glaucoma and the leading cause of blindness among adults in the US – mostly because it can progress gradually and go unnoticed for years. An increase in eye pressure occurs slowly over time. This pressure pushes on the optic nerve and the retina at the back of the eye. The cause of open-angle glaucoma is unknown, but it tends to be hereditary, with people of African descent at particularly high risk.
About Clermont Pharmaceuticals
Clermont Pharmaceuticals, Inc. is a privately held Florida based ophthalmic pharmaceutical company focused on the development of new medicines for the treatment glaucoma.
About Laboratoires Thea
Laboratoires Thea was founded in 1994 and is managed by Henri and Jean-Frederic Chibret. Laboratoires Thea is a 350 MUSD ophthalmic pharmaceutical company and is the leading independent ophthalmic group in Europe and is committed to the development and marketing of innovative ophthalmic drugs, medical devices, and nutraceuticals.
SOURCE Clermont Pharmaceuticals, Inc.
CONTACT: Philippe Boulangeat, +1-813-919-9402, or Barry Butler, +1-813-766-9539
Posted: September 2011