Fluocinolone acetonide SR is under clinical development by EyePoint Pharmaceuticals and currently in Phase III for Retinopathy. According to GlobalData, Phase III drugs for Retinopathy have a 60% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Fluocinolone acetonide SR’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.
Fluocinolone acetonide SR overview
Fluocinolone acetonide (Iluvien, Medidur, Yutiq) is a glucocorticoid derivative. It is formulated as an injectable, non-erodible, intravitreal implant in a 36-month sustained-release drug delivery system. It is indicated for the treatment of vision impairment associated with chronic diabetic macular edema, considered insufficiently responsive to available therapies, for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure, and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU). It is based on Durasert technology system and Medidur Delivery system and CONTINUOUS MICRODOSING technology.
Fluocinolone acetonide is under development for the treatment of posterior uveitis, non-infectious uveitis and diabetic macular edema. It was also under development for the treatment of retinal vein occlusion, retinitis pigmentosa, geographic atrophy (an advanced form of dry age-related macular degeneration), exudative age-related macular degeneration and osteoarthritis. It was under development for the treatment of posterior uveitis (intraocular route).
EyePoint Pharmaceuticals overview
EyePoint Pharmaceuticals (EyePoint), formerly pSivida, is a pharmaceutical company that develops and commercializes therapies for treatment of eye disorders. The company utilizes its Duraset platform, a miniaturized, injectable, and sustained delivery system to develop its product. Its pipeline products includes EYP-1901, an investigational sustained delivery intravital anti-VEGF treatment that targets wet age-related macular degeneration (Wet AMD), non-proliferative diabetic retinopathy (NPDR), and diabetic macularedema (DME). The company also markets its product such as Yutiq, a fluocinolone acetonide intravitreal implant to treat chronic non-infectious uvetis; and Dexycu for treatment of postoperative inflammation. EyePoint is headquartered in Watertown, Massachusetts, the US.
For a complete picture of Fluocinolone acetonide SR’s drug-specific PTSR and LoA scores, buy the report here.
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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 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.
