CLINICAL TRIALS
NEXAGON FOR THE TREATMENT OF PCED
SECONDARY TO CHEMICAL/THERMAL INJURY
NEX-PED-005 (EXPEDE)
(NCT04081103)
A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled Study to Assess the Efficacy and Safety of Nexagon® (NEXAGON) Applied Topically in Subjects With Corneal Persistent Epithelial Defects Resulting From Severe Ocular Chemical and/or Thermal Injuries
Data to be shared at ARVO 04.23.25
NEX-PED-005 (EXPEDE) Trial Design
Chemical and/or Thermal Injury
Day 28
Re-epithelialization Assessment*
Final
Durability
Assessment
≥ 14-day Screening Period
28-day Treatment Period
28-day Follow-up
Period (Durability)
*Once a subject achieves re-epithelialization, they enter the 28-day follow-up period (durability)
Subjects that do not re-epithelialize during the treatment period or do not maintain
re-epithelialization during the follow up period, are eligible for open-label NEXAGON treatment
Study Population
Subjects with PED resulting from severe chemical and/or
thermal injury refractory to current standard of care for ≥ 14 days
Randomized 1:1:1
NEXAGON, 0. 06 %
NEXAGON, 0.006 %
NEXAGON Vehicle
Primary Endpoint
Corneal Epithelial Recovery, defined as a cornea that re-epithelializes by Treatment Day 28 and remains re-epithelialized for at least 28 days
NEXAGON FOR THE TREATMENT OF PCED
AMB-01-006 (NEXPEDE-1)
A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2/3 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects with Persistent Corneal Epithelial Defects
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Dosing Regimen: Intermittent in-office topical administration
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Treatment Duration: 4-8 weeks
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Population: Patients >2 years of age with a persistent corneal epithelial defect of non-infectious origin
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Primary Endpoint: Proportion of subjects achieving complete corneal healing
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Status: Reviewing sites for inclusion in the study
For additional info and to be considered as a potential site,
please email clinical@amberophthalmics.com
Persistent Corneal Epithelial Defect (PCED) is an orphan indication and NEXAGON has been granted Orphan Drug Designation (ODD) for PCED by the FDA.