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.