A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED

This study is a randomized, multicenter, double-masked, vehicle-controlled study to evaluate the safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in subjects with persistent corneal epithelial defects (PCED). The study will enroll subjects who will complete a Screening Period, Treatment Period (up to 8 weeks) and Follow-up Period (4 weeks). Those subjects whose defect has not re-epithelialized by the completion of the Treatment Period or who achieved re-epithelialization but failed to maintain re-epithelialization for 28 days after treatment completion (durability) are eligible to enter the NEXAGON Open-label Treatment Period for an additional 8 weeks.

Inclusion criteria

• Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments
• Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
• Subject must provide written informed consent (or assent)
• Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test

Exclusion criteria

• Have a known ocular infection that is deemed to be active requiring therapeutic intervention
• Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and/or protozoal) that has not fully resolved and/or treatment has not been completed
• Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
• Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
• Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
• Have any other ocular disease requiring topical ocular medication in the affected eye
• Have a presence or history of any ocular or systemic disorder or condition that could interfere the safety or efficacy of the study treatment, or the interpretation of the study results
• Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)
• Participated in an interventional clinical drug or device trial within 28 days prior to Day 1
• Use of the medications presented in the protocol that are prohibited in the study.