Moxifloxacin / Dexamethasone Ophthalmic Solution — Competitive Intelligence Brief

Moxifloxacin / Dexamethasone Ophthalmic Solution (Moxifloxacin / Dexamethasone Ophthalmic Solution) competitive landscape: 4 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Fluoroquinolone antibiotic + Corticosteroid combination. Area: Ophthalmology.

phase 3 Fluoroquinolone antibiotic + Corticosteroid combination Bacterial DNA gyrase, topoisomerase IV (moxifloxacin); Glucocorticoid receptor (dexamethasone) Ophthalmology Small molecule

Target snapshot

Moxifloxacin / Dexamethasone Ophthalmic Solution (Moxifloxacin / Dexamethasone Ophthalmic Solution) — Laboratorios Sophia S.A de C.V.. Moxifloxacin is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, while dexamethasone is a corticosteroid that reduces inflammation in the eye.

Comparator set (4 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Moxifloxacin / Dexamethasone Ophthalmic Solution TARGET	Moxifloxacin / Dexamethasone Ophthalmic Solution	Laboratorios Sophia S.A de C.V.	phase 3	Fluoroquinolone antibiotic + Corticosteroid combination	Bacterial DNA gyrase, topoisomerase IV (moxifloxacin); Glucocorticoid receptor (dexamethasone)
moxifloxacin / dexamethasone	moxifloxacin / dexamethasone	Federal University of São Paulo	marketed	Fluoroquinolone antibiotic + corticosteroid combination	Bacterial DNA gyrase, topoisomerase IV, glucocorticoid receptor
Levofloxacin + dexamethasone followed by dexamethasone	Levofloxacin + dexamethasone followed by dexamethasone	NTC srl	phase 3	Fluoroquinolone antibiotic + corticosteroid combination	Bacterial DNA gyrase, topoisomerase IV (levofloxacin); glucocorticoid receptor (dexamethasone)
Ciprofloxacin HCl and Hydrocortisone	Ciprofloxacin HCl and Hydrocortisone	Farmoquimica S.A.	phase 3	Fluoroquinolone antibiotic + corticosteroid combination	Bacterial DNA gyrase and topoisomerase IV; glucocorticoid receptor
Moxifloxacin and Dexamethasone combined	Moxifloxacin and Dexamethasone combined	Federal University of São Paulo	phase 3	Fluoroquinolone antibiotic + Corticosteroid combination	Bacterial DNA gyrase, topoisomerase IV (moxifloxacin); Glucocorticoid receptor (dexamethasone)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Fluoroquinolone antibiotic + Corticosteroid combination class)

1. Federal University of São Paulo · 1 drug in this class
2. Laboratorios Sophia S.A de C.V. · 1 drug in this class