RGX-314 is under clinical development by AbbVie and currently in the Phase II and Phase III 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 RGX-314’s likelihood of approval (LoA) and phase transition for Choroidal Neovascularization took place on 04 Aug 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.

In addition, the same event on 04 Aug 2022 decreased RGX-314’s LoA and PTSR for Diabetic Retinopathy.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their RGX-314 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

RGX-314 overview

RGX-314 is under development for the treatment of wet age-related macular degeneration, diabetic retinopathy and anti-VEGF treated retinal diseases. It is administered through subretinal and suprachoroidal route. It targets vascular endothelial growth factor A (VEGF-A). The therapeutic candidate is a gene therapy (adeno-associated virus vector serotype 8 (AAV8) vector encoding a gene for monoclonal antibody fragment which binds to VEGF) based on the NAV technology platform.

AbbVie overview

AbbVie is a specialty biopharmaceutical company, which discovers, develops, manufactures, and commercializes drugs for the treatment of chronic and complex diseases. Its drugs are indicated for the treatment of metabolic diseases, rheumatological diseases, neurological disorders, viral diseases, skin diseases, complications associated with cystic fibrosis, pain related to endometriosis, diseases of the gastrointestinal tract, various types of cancer, and other serious health conditions. AbbVie is also advancing its pipeline programs for the treatment of cystic fibrosis, women’s health, various cancers, neurological disorders and other autoimmune diseases. The company markets its products directly to wholesalers, distributors, health care facilities, government agencies, specialty pharmacies and independent retailers through its own distribution centers and public warehouses worldwide. AbbVie is headquartered in North Chicago, Illinois, the US.

Quick View RGX-314 LOA Data

Report Segments
  • Innovator
Drug Name
  • RGX-314
Administration Pathway
  • Intraocular
Therapeutic Areas
  • Metabolic Disorders
  • Ophthalmology
Key Developers
  • Sponsor Company: AbbVie
  • Originator: RegenxBio
Highest Development Stage
  • Phase III

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.