Amber Ophthalmics, Inc. (Amber), a privately held, clinical stage biopharmaceutical company, announced that Mark S. Gorovoy, MD, from Gorovoy M.D. Eye Specialists has enrolled the first patient in the AMB-01-006 (NEXPEDE-1) study.
The NEXPEDE-1 study is 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) (NCT05966493).
This study evaluates the safety and efficacy of Nexagon, in a dosing regimen that utilizes as few as 5 topical in-office administrations for subjects with confirmed non-infectious 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”, said Shawn A. Scranton, PharmD, president and CSO of Amber. “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.”
LUFEPIRSEN OPHTHALMIC GEL (NEXAGON) 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 unique 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.