Delving into the Latest Updates on Dexamethasone/Moxifloxacin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

MoxiDex Otic, Moxifloxacin/dexamethasone, VIGADEXA

+ [3]

Target

Bacterial DNA gyrase x Bacterial top IV x GR

Action

inhibitors, agonists

Mechanism

Bacterial DNA gyrase inhibitors(Bacterial DNA gyrase inhibitors), Bacterial top IV inhibitors(Bacterial topoisomerase IV inhibitors), GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Infectious DiseasesEye DiseasesOther Diseases

Active Indication

Eye InfectionsPost procedural inflammation

Inactive Indication

Acute otitis externaAcute transudative otitis mediaBlepharitis+ [6]

Originator Organization

Alcon AG

Active Organization

Ocumension Suzhou Biotech Co., Ltd.

Alcon AG

Hangzhou Minsheng Pharmaceutical Co., Ltd.

Inactive Organization

Alcon Research Ltd.EMS SA (Brazil)

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC21H25ClFN3O4

InChIKeyIDIIJJHBXUESQI-DFIJPDEKSA-N

CAS Registry186826-86-8

BACKGROUNDIntracameral antibiotics, such as moxifloxacin and cefuroxime, are safe to corneal endothelial cells and effective prophylaxis of endophthalmitis after cataract surgery. Corneal endothelial cells decrease in density after cataract surgery. Any substance used in the anterior chamber may affect corneal endothelial cells and lead to a greater decrease in density. This study wants to determine the percentage of endothelial cell loss after cataract extraction by phacoemulsification with off-label intracameral injection of moxifloxacin and dexamethasone (Vigadexa®).METHODSAn observational retrospective study was performed. The clinical records of patients undergoing cataract surgery by phacoemulsification plus intracameral injection of Vigadexa® were analyzed. Endothelial cell loss (ECL) was calculated using preoperative and postoperative endothelial cell density. The relation of endothelial cell loss with cataract grade using LOCS III classification, total surgery time, total ultrasound time, total longitudinal power time, total torsional amplitude time, total aspiration time, estimated fluid usage, and cumulative dissipated energy (CDE) was studied using univariate linear regression analysis and logistic regression analysis.RESULTSThe median loss of corneal endothelial cells was 4.6%, interquartile range 0 to 10.4%. Nuclear color and CDE were associated with increased ECL. ECL>10% was associated with age and total ultrasound time in seconds.CONCLUSIONSThe endothelial cell loss after the intracameral use of Vigadexa® at the end of cataract surgery was similar to the reported in other studies of cataract surgery without the use of intracameral prophylaxis for postoperative endophthalmitis (POE). This study confirmed the association of CDE and nuclear opalescence grade with postoperative corneal endothelial cell loss.

01 Jan 2007·Current Medical Research and OpinionQ4 · MEDICINE

Efficacy and tolerability of a combined moxifloxacin/dexamethasone formulation for topical prophylaxis and reduction of inflammation in phacoemulsification: a comparative, double masked clinical trial

Q4 · MEDICINE

Article

Author: Soriano, Eduardo ; Lemes Freitas, Lincoln ; Luisa Höfling-Lima, Ana ; Belfort, Rubens ; Muccioli, Cristina

PURPOSETo compare the efficacy and safety of a combined 0.5% moxifloxacin and 0.1% dexamethasone formulation (Vigadexa) versus conventional dosing with 0.5% concomitant moxifloxacin (Vigamox) and 0.1% dexamethasone (Maxidex) for the prevention of infection and control of inflammation after cataract surgery.SETTINGThe ophthalmology clinic and outpatient surgery suite of a public hospital in Brazil.METHODSA prospective, randomized, double-masked, parallel-group study of 139 patients, all of which underwent phacoemulsification and intraocular lens (IOL) implantation. After random assignment, 64 eyes received the combination of topical 0.5% moxifloxacin/0.1% dexamethasone drop and 62 eyes received 0.5% moxifloxacin and 0.1% dexamethasone as separate solutions four times a day for 15 days. Baseline and postoperative assessments were made on surgery days -2, 1, 3, 8, and 15. Limitations of this study included its small size and relatively short duration of follow-up.RESULTSThere was no sign of intraocular infection at any time and only minimal inflammation beyond day 3. Physicians rated bacterial infection to be absent in both groups on days 1, 3, 8 and 15. Ninety-seven percent of patients in each group had < or = 5 cells by day 15. Objective and subjective parameters were essentially the same in both treatment groups (p > 0.05). One patient in the conventional therapy group developed viral conjunctivitis unrelated to the surgery.CONCLUSIONTreatment with the combined moxiflox acin/dexamethasone eye drops was as effective as conventional treatment in preventing infection and controlling inflammation after phacoemulsification and IOL implantation.

100 Deals associated with Dexamethasone/Moxifloxacin

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	S01CA01 S03CA01 S02CA06 D07CB04	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Eye Infections	-	Alcon AG	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cataract	Phase 2	-	Alcon Research Ltd.	01 Mar 2014
Blepharitis	Phase 2	Brazil	Alcon Research Ltd.	01 Aug 2008
Conjunctivitis	Phase 2	Brazil	Alcon Research Ltd.	01 Aug 2008
Eye Infections, Bacterial	Phase 2	Brazil	Alcon Research Ltd.	01 Aug 2008
Keratitis	Phase 2	Brazil	Alcon Research Ltd.	01 Aug 2008
Acute otitis externa	Phase 2	-	Alcon Research Ltd.	01 Jun 2008
Acute transudative otitis media	Phase 2	-	Alcon Research Ltd.	01 Dec 2005
Cataract	Preclinical	-	Alcon Research Ltd.	01 Mar 2014
Keratitis	Preclinical	Brazil	Alcon Research Ltd.	01 Aug 2008
Acute transudative otitis media	Preclinical	-	Alcon Research Ltd.	01 Dec 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01859702 (CTgov)	Phase 4	Cataract	36	Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution	nxsmnfvjgz(dogxwxflyi) = raxnyfnuot lfashqfaxf (ygitvynloc, iemycztmfe - kptnsaoifv) View more	-	07 Aug 2013
NCT00870103 (CTgov)	Phase 4	Cataract \| Inflammation \| Infectious Diseases	64	Vigadexa	hkkbmmiyip(khwoovilok) = dgmgjoyolk rjduecmgpu (wsgnnztosc, zidzuxbcna - eduatuypvk) View more	-	15 Feb 2010