Navigation Links
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%).

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 pat ients 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.


'"/>




Related medicine news :

1. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
2. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
3. Pharma cos must forge Strategic alliances
4. Medicis Pharmaceutical company enters pediatric market
5. Pharma majors gear to supply anti-anthrax drug
6. Pharmacies in for a dose of bitter medicine
7. Andhra Pradesh to set up Pharma City
8. Sun Pharma to launch chiral version of omeprazole soon
9. AAI Pharma Files Lawsuit Against Dr. Reddys Laboratories
10. Pharmacia may take 51.5 percent Abbott stake
11. Pharmaceutical companies are targeting patients
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/26/2017)... ... 2017 , ... New patients with missing teeth in Fitchburg, WI, ... referral. Dr. Cotey is a trusted dentist who has placed many dental implants and ... with missing teeth in Fitchburg, WI, are encouraged to find out if they are ...
(Date:6/25/2017)... ... June 25, 2017 , ... Republicans in the United States Senate on ... the Better Care Reconciliation Act. It differs significantly from the American Health Care Act, ... reconciled in committee, or the House will have to take up the Senate version ...
(Date:6/25/2017)... ... 25, 2017 , ... With a heatwave currently bearing down on Northern California pushing temperatures to ... Being swimsuit ready is easy with laser hair removal. , The process of summer ... burdensome routine when all you want to do is get out, dive in and cool ...
(Date:6/24/2017)... ... June 24, 2017 , ... The Pennsylvania Athletic Trainers’ Society’s ... and Erie Convention Center on June 8-10. The weekend consisted of many ... award and scholarship presentations, and professional networking. , On Friday June 9th, ...
(Date:6/24/2017)... ... ... Doorknobs are for convenience, deadbolts are for security. , There are many ... an alarm system installed. But unless there is a working deadbolt lock that is ... Premier Locksmith in Killeen, TX says: “In the majority of home burglaries, intruders use ...
Breaking Medicine News(10 mins):
(Date:6/5/2017)... Kohll,s Pharmacy & Homecare is the first distributor of ... . The Raizer is a simple battery operated mobile ... an almost-standing position within a few minutes. The ... and does not require any extra effort besides a ... can operate it, and lightweight and portable so ...
(Date:5/30/2017)... , May 30, 2017 Hill-Rom Holdings, Inc. ... Annual Global Healthcare Conference on Tuesday, June 13, 2017, ... John Greisch , Hill-Rom,s president and chief executive officer, is ... The live audio webcast can be accessed at http://ir.hill-rom.com/events.cfm ... conclusion of the live event through September 13, 2017. ...
(Date:5/24/2017)... Va. , May 24, 2017  ivWatch ... Original Equipment Manufacturer (OEM) Board to enable seamless ... with patient monitoring systems, infusion pumps and other ... OEMs will be able to help health care ... and reduced risks related to IV therapy. ...
Breaking Medicine Technology: