EVRY, France, June 25 /PRNewswire/ --     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%).

Vekacia(R) improved both signs and ocular symptoms of VKC in children who
received treatment. The superiority of Vekacia(R) over its vehicle has been
demonstrated by the statistically significant improvement of both objective
signs of VKC and keratitis in treated patients. Both doses were safe and well
tolerated. Local tolerance at instillation was satisfactory and therefore
compliance to the recommended dose regimen of four instillations per day was
good. Systemic exposure to CsA was negligible in the treated patients.
Compliance to the study regimen of four daily instillations of the drug was
excellent.

Overall improvement of subjective symptoms (burning/stinging, tearing,
itching, pain, sticky eyelids, foreign body sensation, mucus discharge and
photophobia) was superior to the vehicle for both concentrations of
Vekacia(R). For objective signs (conjunctival erythema/hyperhemia,
conjunctival chemosis and discharge, papillae, limbal infiltrates and corneal
epithelial disease), there was a statistically significant difference between
both concentrations of Vekacia(R) and the vehicle treatment (p=0.0386 and
0.0208 for the Vekacia(R) 0.05% and Vekacia(R) 0.1% treatment arms,
respectively). Similarly, improvement in superficial keratitis was
statistically significant with Vekacia(R) 0.05% versus vehicle (p=0.0176).

At one month of study, only seven patients had withdrawn from the study,
which comprised four patients using the vehicle and three patients using
Vekacia(R), including one case of ocular intolerance following study drug
instillation. Few treatment-emergent adverse effects (TEAEs) were reported,
the most frequent being eye disorders of mild intensity. The tested
formulations were rated as comfortable by 94.4% (vehicle), 79.5% (Vekacia(R)
0.05%) and 80.6% (Vekacia(R) 0.1%). Blood levels of CsA were assayed after
one month of treatment in 16 patients treated with Vekacia(R) and five
patients had detectable CsA levels below 0.33ng/ml, a value which is
considered as negligible

These results are presented at the occasion of a Symposium chaired by Pr
BenEzra, lead coordinator of the study.

About Novagali Pharma Vekacia(R):

Vekacia(R) is a Cyclosporine A ophthalmic product intended for patients
suffering from vernal keratoconjunctivitis. Vekacia(R) is a proprietary
cationic emulsion enabling an efficient and unmatched-level drug absorption
in tissues of the eye leading to optimal therapeutic efficacy.

About Novagali Pharma: www.novagali.com

Novagali Pharma SA is an emerging ophthalmic pharmaceutical company based
in the Genopole biocluster in Evry, France, that develops innovative products
for all segments of the eye. Thanks to its proprietary technology platforms
Novasorb(R) and Eyeject(R), the company has developed a broad pipeline of
innovative products addressing main ocular conditions as well as orphan
diseases. Most advanced products include Vekacia(R), an orphan product for
treatment of vernal keratoconjunctivitis; Cationorm(R), a CE marking product
for dry eye relief; and Nova22007, a product for the treatment of
moderate-to-severe dry eye syndrome. Founded in 2000, the firm has raised a
total amount of Euro 44 million in 3 series of financing and currently has 38
employees.

Contacts Presse

    Novagali
    VP HR & Communication
    Genevieve Garrigos
    +33-1-69-87-40-20
    genevieve.garrigos@novagali.com

    Euro RSCG
    Estelle Griffe
    + 33-1-58-47-95-25
    + 33-6-23-75-09-23
    Estelle.griffe@eurorscg.fr