Baluretgene parvec is under clinical development by Ocugen and currently in Phase III for Leber Congenital Amaurosis (LCA). According to GlobalData, Phase III drugs for Leber Congenital Amaurosis (LCA) have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Baluretgene parvec’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Baluretgene parvec overview
Baluretgene parvec (OCU-400) is under development for the treatment of inherited degenerative retinal diseases (IRDs) such as NR2E3, CEP290, PDE6B and RHO mutation-associated recessive retinal degeneration, Leber Congenital Amaurosis (LCA), Bardet-Biedl Syndrome (BBS), enhanced S-cone syndrome and rhodopsin mutations associated retinitis pigmentosa and other retinal degenerations. It is administered as sub-retinal injection. The therapeutic candidate is an adeno-associated virus serotype 5 capsid containing the gene for human nuclear hormone receptor NR2E3. It is developed based on modifier gene therapy platform. It acts by targeting centrosomal protein of 290 kDa (CEP290) and Rhodopsin
Ocugen overview
Ocugen is a biopharmaceutical company that discovers, develops and commercializes and vaccines for improvement health for the treatment of eyes. The company’s pipeline products include OCU-400 for the treatment of NR2E3, RHO, CEP290, and PDE6B mutation associated retinal degeneration; OCU-410 targets dry age-related macular degeneration; OCU410ST treats targardt orphan disease; OCU200 for diabetic macular edema, diabetic retinopathy, wet-age related macular degeneration; NEOCART treats articular cartilage defects in the knee, OCU500 targets covid 19; OCU510 for flu; OCU520 is for the treatment of flu and covid 19. It utilizes a modified gene therapy platform to develop its products. The company operates in Ireland and the US. Ocugen is headquartered in Malvern, Pennsylvania, the US.
For a complete picture of Baluretgene parvec’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
