Navigation Links
Fovea Reports Positive Results with Prednisporin(TM) in Persistent Allergic Conjunctivitis
Date:5/4/2009

PARIS, May 4 /PRNewswire/ -- Fovea Pharmaceuticals announced today positive results from its clinical proof-of-concept trial to assess the therapeutic effect of Prednisporin(TM) (FOV1101) in patients with persistent allergic conjunctivitis.

Prednisporin(TM) had the same efficacy and a better safety profile (no increase in intra-ocular pressure) than PredForte(TM), a prescription drug with a 10 fold higher dose of prednisolone acetate, in patients treated for the signs and symptoms (itching and redness) of persistent ocular allergic inflammation. A one-week pre-treatment with Pataday(TM) (an anti-histamine) had negligible effect on these parameters in this patient population.

The prospective, multicenter, randomized, double masked, bilateral comparison study with 150 patients was conducted by Ora Inc., in the USA utilizing Ora's Enviro-CAC(TM) clinical technology. The combination therapy of low doses cyclosporine A and prednisolone acetate was compared to PredForte(TM) alone or vehicle alone during a 2-week dosing period.

"We are extremely pleased with these results, and they are totally in line with our expectations," said Bernard Gilly, Chairman and Chief Executive Officer of Fovea. "We believe that Prednisporin(TM) has the potential to provide safe and effective therapy to millions of patients suffering from chronic inflammatory conjunctivitis, a complex indication, that is not addressed by existing treatments."

Prednisporin(TM) is the first combination therapy developed for the treatment of persistent allergic conjunctivitis. It is a proprietary topical formulation of lower than the usual therapeutic doses prednisolone acetate and cyclosporine A, to retain the efficacy of a very potent steroid with an improved safety profile. The concept was first discovered and patented by CombinatoRx (Nasdaq: CRXX) and Fovea holds an exclusive worldwide license to this intellectual property for ophthalmic indications.

"This study validates both a new clinical technology and new therapeutic approach," said Mark B. Abelson, M.D., Chairman and Chief Scientific Officer of Ora, Inc. "Patients with a history of chronic ocular background inflammation make up a large segment of the ocular allergy market, and are also patients that tend to evolve towards dry eye, another significant ocular disorder. In this study, they have been treated effectively and safely by Prednisporin(TM)."

Allergic conjunctivitis is a frequent disorder. It occurs in up to 90% of patients suffering from allergies and in more than 20% of the global population. In the USA alone, 80 million people experience ocular surface allergy and inflammation. More than 50% of all forms of allergic conjunctivitis have a chronic inflammatory background (persistent allergic conjunctivitis). As current therapies do not address the underlying chronic inflammation, they fail to treat such a disease effectively. Significant opportunities exist for novel products in the ocular allergy market.

Fovea is now preparing pivotal trials for Prednisporin(TM) both in the USA and in Europe with the goal of filing NDA applications late 2010.

About Fovea Pharmaceuticals

Fovea Pharmaceuticals SA (Fovea) is a privately-held biopharmaceutical company specialized in development and commercialization of drugs for the treatment of ocular diseases, with a special focus on retinal pathologies. Founded in May 2005, Fovea has raised euro 50.5m ($69m) in two financing rounds from a strong international syndicate of investors.

Fovea has built a project portfolio including internal research programs on dry AMD, glaucoma (neuroprotection) and retinal dystrophies as well as clinical programs underway for such indications as allergic conjunctivitis, diabetic macular edema, retinal vein occlusion, and retinitis pigmentosa.

To advance the development and commercialization of its programs, Fovea is working both independently and through collaborations with industrial partners like Dyax, Novartis, Genzyme and CombinatoRx, as well as with academic teams, like the Inserm unit U968 (Vision Institute), the Rothschild Ophthalmological Foundation or the Johns Hopkins University.

For more information, please visit www.fovea-pharma.com

About Ora

Ora is the world's leading independent ophthalmic drug and device development firm, with more than 30 NDA approvals during its 30-year history. Ora provides technology-based, concept-to-market services and solutions that accelerate development timelines and improve the predictability of clinical research. Prednisporin(TM) trial was conducted using the Enviro-CAC(TM) which is an evolution of the standard clinical model for ocular allergy, Ora's proprietary Conjunctival Allergen Challenge (CAC) which has been used for development and approval of 14 ocular allergy products.

For more information, please visit www.oraclinical.com.

    Fovea Pharmaceuticals SA:
    Bernard Davitian
    Chief Financial Officer
    +33 1 44 16 42 61
    info@fovea-pharma.com

    Fovea Press Contact France:
    Marie Carole de Groc
    EuroRSCG C&O
    +33 1 58 47 95 07
    marie-carole.de-groc@eurorscg.fr

    Fovea Press Contact U.S.:
    Martina Schwarzkopf, Ph.D.
    Russo Partners, LLC
    +1 212-845-4292
    martina.schwarzkopf@russopartnersllc.com


'/>"/>
SOURCE Fovea Pharmaceuticals
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Fovea Pharmaceuticals Receives Orphan Drug Designation from EC for RdCVF for the Treatment of Retinitis Pigmentosa
2. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
3. Spherix Reports Second Quarter Earnings
4. Tapestry Reports Second Quarter 2007 Results
5. Callisto Reports on Second-Quarter 2007 Milestones
6. ImmuneRegen BioSciences Reports Material Transfer Agreement with VaxGen, Inc.
7. Vical Reports Second Quarter 2007 Financial Results, Allowance of Pandemic Influenza IND and Other Advances in Product Development Programs
8. Paper in International Journal of Oncology Reports Alfacells ONCONASE(R) Suppresses Intracellular Oxidative Stress
9. TAXUS WOMAN Study Reports Positive Clinical Outcomes for the TAXUS(R) Drug-eluting Stent in Women
10. Biopure Reports on Meeting with the FDA
11. Peregrine Reports Data Showing Bavituximabs Potential to Shrink Prostate Tumors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... March 23, 2017 Prima BioMed ... TACTI-mel trial of IMP321 in combination with Keytruda, with ... (1mg/kg) cohort experiencing a complete response. Recruitment in the ... expected to be fully recruited by Q317. Preliminary efficacy ... breast cancer study are expected mid-year (recruitment in the ...
(Date:3/23/2017)... ALBANY, New York , March 23, 2017 ... devices market exhibits a consolidated vendor landscape with the ... the overall market in 2015. These companies are ... Industries, Inc., Hygia Health Services, Inc., and VANGUARD ... global reprocessed medical devices market is witnessing the ...
(Date:3/23/2017)... , March 23, 2017 ... Enterprises Limited, anuncia el nombramiento de Stuart ... una plataforma de servicios integrados completa para su ... un cargo clave en el crecimiento y ejecución ... será responsable de impulsar todas las actividades de ...
Breaking Medicine Technology:
(Date:3/23/2017)... Holland, PA and Grimsby, Ontario (PRWEB) , ... March 23, 2017 , ... The MBI ... the modular industry or whose acts have had a significant impact on the careers of ... Sales and Marketing with NRB Inc. was inducted into the MBI’s Hall of Fame. ...
(Date:3/23/2017)... ... March 23, 2017 , ... ... Management Accreditation from the NCQA. The accreditation covers StayWell’s asthma, coronary artery disease, ... status is granted to organizations that have excellent programs for the delivery and ...
(Date:3/23/2017)... ... March 23, 2017 , ... March 23, 2017 - ... to easily reprint customer invoices, bills, statements and other correspondence when they have ... needed to retrieve and print the documents and batch them for efficient handling. ...
(Date:3/23/2017)... ... March 23, 2017 , ... Sharon Kleyne, host of the ... and Your Health on VoiceAmerica, recently talked on her program about how she is ... occasion to remind listeners of an important distinction. World Water Day, Kleyne pointed out, ...
(Date:3/23/2017)... ... March 23, 2017 , ... ... products at competitive pricing. Verisys through its FACIS and other ... restrictions and Disciplinary actions. , “We are delighted to be able to offer ...
Breaking Medicine News(10 mins):