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
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, high
NEXAGON, low
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
NEX-PED-005 (EXPEDE) Results: Primary Endpoint
66.7% of subjects receiving NEXAGON met the primary endpoint
NEXAGON
high dose
NEXAGON
low dose
NEXAGONVehicle
= met primary endpoint, re-epithelialized within 4 weeks + 28-days durable
NEXAGON combined vs. Vehicle, 95% CI = (0.015, 0.674),
p = 0.0652 Fisher's exact test
Study Results
-
NEXAGON provided a ~40% increase in response over vehicle
-
Impressive NEXAGON response rate (~67%) in a difficult PCED population
-
Vehicle rate (~27%) aids in validating study population/conduct
-
NEXAGON demonstrated clinically meaningful response rate in PCED
NEX-PED-005 (EXPEDE) Results: Visual Acuity
ns = not statistically significant
Percentage of subjects with improvement in visual acuity at study completion
*These differences did not reach statistical significance, in part due to the small sample size.
A greater improvement in visual acuity was observed in subjects receiving Nexagon, suggesting a potential treatment-related benefit.
NEXAGON FOR THE TREATMENT OF PCED
AMB-01-006 (NEXPEDE-1)
(NCT05966493)
​
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
​​​
Persistent Corneal Epithelial Defect (PCED) is an orphan indication and NEXAGON has been granted Orphan Drug Designation (ODD) for PCED by the FDA.