Lufepirsen is under clinical development by Amber Ophthalmics and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Lufepirsen’s likelihood of approval (LoA) and phase transition for Persistent Corneal Epithelial Defects took place on 18 Jul 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Lufepirsen Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Lufepirsen overview

Lufepirsen is under development for the treatment of persistent corneal epithelial defects which are secondary to trauma and refractory to standard of care. The drug candidate is applied as an ophthalmic gel. The drug candidate binds to connexin 43. CODA-001 is a natural, unmodified antisense oligonucleotide. It was also under development for the treatment of venous leg ulcer, diabetic foot ulcers, skin wounds, and near sightedness after PRK laser eye surgery.

Amber Ophthalmics overview

Amber Ophthalmics is a biopharmaceutical company that discovers and develops ocular drugs. It is investigating its lead product candidate NEXAGON (lufepirsen), an oligonucleotide-based drug for the treatment of PED CTI (persistent epithelial defects due to thermal and chemical injuries) and ocular surface indications. The company’s product candidate inhibits a cell membrane hemichannel forming protein, connexin43 (Cx43) that is overexpressed after acute injury and chronic disease states. Its drug focuses on re-establishing limbal microvasculature and regenerating the corneal epithelium. Amber Ophthalmics is headquartered in San Diego, California, the US.

Quick View Lufepirsen LOA Data

Report Segments
  • Innovator
Drug Name
  • Lufepirsen
Administration Pathway
  • Ophthalmic
  • Topical
Therapeutic Areas
  • Dermatology
  • Metabolic Disorders
  • Ophthalmology
Key Developers
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.