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Novagali Pharma Presents Phase III Clinical Trial of Vekacia(R) for Vernal Keratoconjunctivitis

Novagali Pharma, an emerging pharmaceutical company specialized in ophthalmology presents positive results of its pivotal phase III clinical trial positive results from the Phase III clinical study of Vekacia(R) in children suffering from Vernal Keratoconjunctivitis (VKC) at the XIV Afro-Asian Congress of ophthalmology (AACO) held from June 20 to 25 2007 in Marrakech (Morocco).

VKC is a severe form of chronic allergic conjunctivitis characterized by ocular discomfort, pain, itching and intense photophobia, which severely debilitates the patients. This rare disease affects mostly children and young adults living in warm climates worldwide. In this orphan disease, it was shown that both symptoms and signs of disease improved in patients receiving Vekacia(R). Furthermore, the tolerability of Vekacia(R) was excellent.

The study was designed as a clinical phase II/III, multicenter, randomized parallel group, double masked, dose ranging, controlled study divided in two treatment periods: (I) a four-week prospective, randomized, multicenter, double-masked, three parallel-group, vehicle-controlled treatment period; and (II) a three-month prospective, multicenter, double-masked treatment period.

The primary objective of Vekacia(R) phase III study was to assess the efficacy of Vekacia(R) 0.05 % and Vekacia(R) 0.1%, administered four times daily, versus a vehicle after a four-week treatment period for patients with VKC. The secondary objectives were to compare the safety and ocular tolerance (objective and subjective) and the long-term safety after four months.

One hundred and eighteen patients (mean age: 8.8) with active bilateral VKC (acute or chronic) were enrolled in the study at over 21 sites in Europe and Mediterranean countries from May 2006 to October 2006. Most patients were suffering from perennial VKC (90 patients, 76.3%) and were presented at study entry with a mixed form of VKC (87 patients, 73.7%).


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