Novagali Pharma Completes Patients Recruitment for Its US Phase II Clinical Trial of Catioprost®
April 14 2011 - 3:00PM
Business Wire
Regulatory News:
Novagali Pharma (Paris:NOVA), a pharmaceutical company that
develops innovative ophthalmic products, announces today the
completion of enrolment for its phase II clinical trial of
Catioprost® in patients with glaucoma and presenting concomitant
damage to the ocular surface.
The randomized phase II trial is a safety and efficacy study of
Catioprost® compared to Travatan Z® to treat glaucoma and ocular
surface disease. It has enrolled 105 patients in the United
States.
Glaucoma is a chronic eye disease that can lead to a gradual
loss of peripheral vision or even irreversible blindness. It is
thought to affect over 70 million people worldwide with 60% also
suffering from damage to the ocular surface which manifests itself
with signs and symptoms similar to those experienced by patients
with dry eye disease1. The global glaucoma market was estimated to
be worth USD 5.3bn in 2009.
Daily administration of topical medication to control
intraocular pressure is the most common therapeutic approach in
glaucoma patients. However, patient age and the long-term use of
formulations containing preservatives, particularly BAK which has
been shown to be toxic to the cornea and the conjunctiva2, may lead
to ocular surface damage of varying degrees of severity. Such
damage may undermine the compliance and efficacy of anti-glaucoma
treatments.
Catioprost® is a preservative-free cationic emulsion containing
0.005% latanoprost, formulated to reduce intraocular pressure while
simultaneously treating damage to the ocular surface. Worldwide,
latanoprost is the compound most often prescribed to control
intraocular pressure. Catioprost® combines latanoprost with
Novagali Pharma's patented Novasorb® technology which has been
shown to improve ocular surface damage in patients with dry eye
disease.
The Phase II clinical study follows preclinical studies at Mount
Sinai Hospital in New York and Quinze-Vingts Hospital in Paris.
These studies have shown the efficacy of Catioprost® in controlling
intraocular pressure, the superiority of its safety profile3 and
its potential for limiting and reversing damage to the ocular
surface relative to other prostaglandin therapies for
glaucoma4.
About NOVAGALI Pharma
(www.novagali.com)
Founded in 2000, Novagali Pharma SA is a pharmaceutical company
that develops innovative ophthalmic products for all segments of
the eye. Thanks to its three proprietary technology platforms, the
Company has an advanced portfolio of highly innovative products,
one of which is already on sale and two of which are in phase III
clinical trials.
In 2009, Frost & Sullivan recognised Novagali with the Award
of the Year for Industry Innovation & Advancement, for its
proprietary emulsion technology platforms, and Siemens awarded the
company the Grand Prix de l’Innovation “Health Award” for
Novasorb®. In April 2010, Novagali Pharma and its partners in the
Vitrena project obtained €9.4 million in funding from OSEO for this
diabetic retinopathy project.
Novagali Pharma successfully carried out an IPO in July 2010
raising 22 million euros.
Novagali Pharma is listed on NYSE Euronext
Paris - Compartment CISIN code: FR0010915553 - Ticker: NOVA
This press release contains certain forward-looking statements.
Although the company believes its expectations are based on
reasonable assumptions, these forward-looking statements are
subject to numerous risks and uncertainties, which could cause
actual results to differ materially from those anticipated. For a
discussion of risks and uncertainties which could cause the
company’s actual results, financial condition, performance or
achievements to differ from those contained in the forward-looking
statements, please refer to the Risk Factors (“Facteurs de Risques
») section of the Document de Base filed with the AMF, which is
available on the AMF website (http://www.amf-france.org) or on
Novagali Pharma’s website (www.novagali.com). This press release
and the information contained herein do not constitute an offer to
sell or a solicitation of an offer to buy or subscribe to
securities of Novagali Pharma in any country.
1 Leung et al. Prevalence of Ocular Surface Disease in Glaucoma
PatientsJournal of Glaucoma 20082 Baudouin C, Labbé A, Liang H,
Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good,
the bad and the ugly. Prog Retin Eye Res. 2010 Jul;29(4):312-34.
Epub 2010 Mar 17.3 Liang et al. Comparison of the ocular
tolerability of a latanoprost cationic emulsion versus conventional
formulations of prostaglandins: an in vivo toxicity assay.
Molecular Vision 2009; 15:1690-16994 Liang et al. In vitro and in
vivo evaluation of newly developed cationic emulsion formulations
in corneal wound healing models. 2010 ARVO proceedings.
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