Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract infections and blockage caused by crystalline biofilm accumulation (encrustation) of the catheter surfaces. When the urine and catheter are colonized by urease-producing bacteria such as Proteus mirabilis, encrustation of the catheter is likely to occur.
The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs and better patient quality of life.
Auriclosene is a non-antibiotic, fast-acting, broad-spectrum antimicrobial, which exhibits potential for the rapid decolonization of a range of urologic pathogens, including the urease-producing Proteus mirabilis.
Subjects will be randomized to either Auriclosene Irrigation Solution or Auriclosene Vehicle solution.

Start Date01 Sep 2014

Sponsor / Collaborator

NovaBay Pharmaceuticals, Inc.

SLCTR/2013/026 / CompletedNot Applicable

A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis

Start Date02 Sep 2013

Sponsor / Collaborator

NovaBay Pharmaceuticals, Inc.

NCT01877694 / CompletedPhase 2

A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis

The purpose of this study is to evaluate the microbiological and clinical efficacy of Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or Vehicle Ophthalmic Solution.

Start Date01 Jun 2013

Sponsor / Collaborator

NovaBay Pharmaceuticals, Inc.

100 Clinical Results associated with Auriclosene

100 Translational Medicine associated with Auriclosene

100 Patents (Medical) associated with Auriclosene

Literatures (Medical) associated with Auriclosene

01 Jan 2022·American Journal of OphthalmologyQ2 · MEDICINE

Molecular and Clinical Characterization of Human Adenovirus E4–Associated Conjunctivitis

Q2 · MEDICINE

Article

Author: Nakamichi, Kenji ; Van Gelder, Russell N ; Stroman, David ; Akileswaran, Lakshmi

PURPOSETo determine the characteristics of conjunctivitis associated with human adenovirus E4 (AdV E4).METHODSSamples and outcomes from 500 patients with conjunctivitis were obtained from the NVC-422 randomized controlled clinical trial comparing auriclosene to placebo. Molecular typing identified 36 cases associated with AdV E4. Signs and symptoms at presentation and at the day 18 endpoint were compared with the larger cohort of 262 subjects with conjunctivitis caused by due to AdV D8. Full viral genomes of 22 AdV E4 isolates were reconstructed.RESULTSAdV E4 was the most frequently identified adenoviral type in conjunctivitis cases from the United States. Signs and symptoms at presentation were comparable to those associated with AdV D8. Viral load at presentation was comparable between groups but resolution was more rapid in the AdV E4 group. Clinical signs were fully resolved by day 18 in 26 of 36 (72%) patients with AdV E4. Subepithelial infiltrates developed in 12 of 36 (33%) patients with AdV E4 compared with 98 of 215 (45%) patients with AdV D8 (P = .0001). One hundred twenty-four polymorphisms were observed among 22 whole viral genome sequences, which clustered into 3 clades. Patients in each clade developed subepithelial infiltrates. Neither single nucleotide polymorphism analysis nor machine learning approaches identified specific sequence features predictive of presenting signs or outcome.CONCLUSIONSAdV E4 conjunctivitis may be indistinguishable at presentation from AdV D8-associated disease. Resolution of viral load for AdV E4 appears more rapid than for AdV D8, and the risk for subepithelial infiltrates appears lower. Multiple substrains of AdV E4 are in circulation but all appeared equivalently pathogenic for conjunctivitis. NOTE: Publication of this article is sponsored by the American Ophthalmological Society.

01 Sep 2018·OphthalmologyQ1 · MEDICINE

Determinants of Outcomes of Adenoviral Keratoconjunctivitis

Q1 · MEDICINE

Article

Author: David Stroman ; Radhika Tandon ; James D. Branch ; Joshua Herz ; Sergio Luis Gianotti Pimentel ; Stephen Smith ; Jonathan Macy ; Vupputuri Venkata Lakshmi ; Anju Kochar ; Cecilia S. Lee ; P.N. Biswas ; Prashant Garg ; Narasimha Rao ; Jacob Moyses Cohen ; El-Roy Dixon ; Jack V. Greiner ; Walton Nose ; James Chodosh ; Andrew L. Moyes ; Nagappa Somshekhar ; K.A. Salvin ; Anna Maria Hofling-Lima ; Syamala H.K. Reddy ; Deepak Mehta ; Virendra Agarwal ; Shree Kumar Reddy ; Adriana dos Santos Forseto ; Champa Banagala ; Russell N. Van Gelder ; Lawerence E. Roel ; Amalia Magaret ; Rubens Belfort ; Yasmin Bhagat ; George Nardin ; Maria Cristina Nishiwaki Dantas ; Larry L. Lothringer ; P.S. Girija Devi ; Manisha Acharya ; Anshu Sahai ; Bernard R. Perez ; Charith Fonseka ; Nivedita Patil ; Anna Wald ; Sherif M. El-Harazi ; D. Wariyapola ; Kathryn Najafi-Tagol ; Shobha Kini ; Sergio Kwitko ; Mary Abraham ; Gregg J. Berdy ; Neil Shmunes ; Michael Tepedino ; Aaron Y. Lee ; Ramon Coral Ghanem ; Stephanie Becker ; Nita Shanbag ; Roberta De Ventura ; Priti Kapadia ; Lakshmi Akileswaran ; Steve Kleiboeker ; Damien Macaluso ; D.R. Kodikara ; M. Wijetunge ; Malavika Krishnaswamy

PURPOSETo determine host and pathogen factors predictive of outcomes in a large clinical cohort with keratoconjunctivitis.DESIGNRetrospective analyses of the clinical and molecular data from a randomized, controlled, masked trial for auricloscene for keratoconjunctivitis (NVC-422 phase IIB, NovaBay; clinicaltrials.gov identifier, NCT01877694).PARTICIPANTSFive hundred participants from United States, India, Brazil, and Sri Lanka with clinical diagnosis of keratoconjunctivitis and positive rapid test results for adenovirus.METHODSClinical signs and symptoms and bilateral conjunctival swabs were obtained on days 1, 3, 6, 11, and 18. Polymerase chain reaction (PCR) analysis was performed to detect and quantify adenovirus in all samples. Regression models were used to evaluate the association of various variables with keratoconjunctivitis outcomes. Time to resolution of each symptom or sign was assessed by adenoviral species with Cox regression.MAIN OUTCOME MEASURESThe difference in composite scores of clinical signs between days 1 and 18, mean visual acuity change between days 1 and 18, and time to resolution of each symptom or sign.RESULTSOf 500 participants, 390 (78%) showed evidence of adenovirus by PCR. Among adenovirus-positive participants, adenovirus D species was most common (63% of total cases), but a total of 4 species and 21 different types of adenovirus were detected. Adenovirus D was associated with more severe signs and symptoms, a higher rate of subepithelial infiltrate development, and a slower decline in viral load compared with all other adenovirus species. The clinical courses of all patients with non-adenovirus D species infection and adenovirus-negative keratoconjunctivitis were similar. Mean change in visual acuity between days 1 and 18 was a gain of 1.9 letters; worse visual outcome was associated with older age.CONCLUSIONSA substantial proportion of keratoconjunctivitis is not associated with a detectable adenovirus. The clinical course of those with adenovirus D keratoconjunctivitis is significantly more severe than those with non-adenovirus D species infections or adenovirus-negative keratoconjunctivitis; high viral load at presentation and non-United States origin of participants is associated with poorer clinical outcome.

01 Jun 2016·UrolithiasisQ2 · MEDICINE

Irrigation with N,N-dichloro-2,2-dimethyltaurine (NVC-422) in a citrate buffer maintains urinary catheter patency in vitro and prevents encrustation by Proteus mirabilis

Q2 · MEDICINE

Article

Author: Debabov, Dmitri ; Najafi, Ron ; Rani, Suriani Abdul ; Celeri, Chris ; Bley, Keith

Long-term use of indwelling urinary catheters can lead to urinary tract infections and loss of catheter patency due to encrustation and blockage. Encrustation of urinary catheters is due to formation of crystalline biofilms by urease-producing microorganisms such as Proteus mirabilis. An in vitro catheter biofilm model (CBM) was used to evaluate current methods for maintaining urinary catheter patency. We compared antimicrobial-coated urinary Foley catheters, with both available catheter irrigation solutions and investigational solutions containing NVC-422 (N,N-dichloro-2,2-dimethyltaurine; a novel broad-spectrum antimicrobial). Inoculation of the CBM reactor with 10(8) colony-forming units of P. mirabilis resulted in crystalline biofilm formation in catheters by 48 h and blockage of catheters within 5 days. Silver hydrogel or nitrofurazone-coated catheters did not extend the duration of catheter patency. Catheters irrigated daily with commercially available solutions such as 0.25 % acetic acid and isotonic saline blocked at the same rate as untreated catheters. Daily irrigations of catheters with 0.2 % NVC-422 in 10 mM acetate-buffered saline pH 4 or Renacidin maintained catheter patency throughout 10-day studies, but P. mirabilis colonization of the CBM remained. In contrast, 0.2 % NVC-422 in citrate buffer (6.6 % citric acid at pH 3.8) resulted in an irrigation solution that not only maintained catheter patency for 10 days but also completely eradicated the P. mirabilis biofilm within one treatment day. These data suggest that an irrigation solution containing the rapidly bactericidal antimicrobial NVC-422 in combination with citric acid to permeabilize crystalline biofilm may significantly enhance catheter patency versus other approved irrigation solutions and antimicrobial-coated catheters.

News (Medical) associated with Auriclosene

13 Jan 2009

·www.biospace.com

NovaBay Pharmaceuticals, Inc. (formerly known as NovaCal Pharmaceuticals, Inc.)’s NVC-422 Cleared by FDA for Human Clinical Trials in Ophthalmology

EMERYVILLE, Calif.--(BUSINESS WIRE)--NovaBay Pharmaceuticals, Inc. (AMEX: NBY, ), announces the clearance of an Investigational New Drug application (IND) submitted by Alcon to the FDA to permit the clinical development of NovaBay’s NVC-422 for infections of the eye. The IND clearance has triggered the immediate payment of the first milestone of $1,000,000 from Alcon to NovaBay.

100 Deals associated with Auriclosene

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Impetigo	Phase 3	-	Galderma International SAS	-
Impetigo	Phase 3	-	NovaBay Pharmaceuticals, Inc.	-
Adenoviral Conjunctivitis	Phase 2	-	Alcon Research Ltd.	01 Jun 2009
Catheter-Related Infections	Phase 2	US	NovaBay Pharmaceuticals, Inc.	29 Oct 2008
Conjunctivitis, Bacterial	Discovery	US	NovaBay Pharmaceuticals, Inc.	01 Jun 2013
Urologic Diseases	Discovery	US	NovaBay Pharmaceuticals, Inc.	01 Nov 2010
Acne Vulgaris	Discovery	US	Galderma Holding SA	01 Apr 2010
Acne Vulgaris	Discovery	US	Galderma Research & Development SNC	01 Apr 2010
Adenoviral Conjunctivitis	Discovery	-	Alcon Research Ltd.	01 Jun 2009
Escherichia Coli Infections	Discovery	US	NovaBay Pharmaceuticals, Inc.	-

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