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

Study Information - clinicaltrials.gov

Interim Data expected in Q1 '23

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)

COMING SOON - Q1 '23

Persistent Corneal Epithelial Defect (PCED) is an orphan indication and NEXAGON has been granted Orphan Drug Designation (ODD) for PCED by the FDA.