Amber Ophthalmics Announces First Patient Enrolled in Phase 2/3 Trial Evaluating Nexagon for the Treatment of PCED

Amber Ophthalmics announced that Mark S. Gorovoy, MD, has enrolled the first patient in the AMB-01-006 (NEXPEDE-1), a randomized, double-masked, vehicle-controlled phase 2/3 clinical trial designed to evaluate two concentrations of Nexagon (lufepirsen ophthalmic gel) for the treatment of persistent corneal epithelial defects (PCED) (ClinicalTrials.gov identifier: NCT05966493).

This study is evaluating the safety and efficacy of Nexagon in a dosing regimen that utilizes as few as 5 topical in-office administrations for subjects with confirmed noninfectious PCED. Subjects who do not re-epithelialize within the first 4 weeks of treatment will continue to receive weekly administrations until subjects either achieve re-epithelialization or complete 8 weeks of therapy. The primary endpoint for the NEXPEDE-1 study will be complete corneal healing as determined by corneal fluorescein staining. 

“We are excited to have enrolled the first subject into the NEXPEDE-1 study and are fortunate to have a strong contingency of clinical sites dedicated to the treatment of PCED," Shawn A. Scranton, PharmD, President and CSO of Amber, said in a company news release. “We look to expeditiously complete this study, as it will further guide the development of this first-in-class PCED therapy that we believe can address a variety of the underlying PCED etiologies.”  

Nexagon, or Lufepirsen ophthalmic gel, is a patent protected, unmodified antisense oligonucleotide that inhibits connexin43 protein translation, a cell membrane hemichannel forming protein associated with ocular inflammation and progression of PCED disease pathology. As a result of Nexagon’s mechanism of action, the medication may be administered topically in the office by the physician at a frequency far less than the current treatment paradigm consisting of multiple daily patient-administered drops.