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Sumitomo Pharma America Announces that its Investigational Therapy DSP-3077 Has Received FDA Orphan Drug Designation for the Treatment of Retinitis Pigmentosa
Sumitomo Pharma America, Inc. (SMPA) today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to its investigational therapy DSP-3077 for the treatment of retinitis pigmentosa (RP). DSP-3077 is an investigative regenerative cell therapy that leverages allogeneic retinal sheets derived from induced pluripotent stem (iPS) cells.
About this update from Sumitomo Pharma Co.ltd.
[{"type":"text","content":"– DSP-3077, an investigational allogeneic iPS cell-derived retinal sheet (3-dimensional [3D] retina), is being evaluated in patients in a Phase 1/2 study –– Retinitis pigmentosa (RP) is a group of genetic eye disorders characterized by the progressive degeneration of photoreceptor cells in the retina, leading to vision loss1 –","length":329,"tagName":"p","attribs":{}},{"type":"text","content":"MARLBOROUGH, Mass., March 23, 2026 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to its investigational therapy DSP-3077 for the treatment of retinitis pigmentosa (RP). DSP-3077 is an investigative regenerative cell therapy that leverages allogeneic retinal sheets derived from induced pluripotent stem (iPS) cells.","length":419,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Sumitomo Pharma America)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Sumitomo Pharma America)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":54,"url":"https://media.zenfs.com/en/prnewswire.com/1ce2acbb19a4341123366f9481a836d7"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/BzyE__bOaSB8gEVtB5lYLQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTk1/https://media.zenfs.com/en/prnewswire.com/1ce2acbb19a4341123366f9481a836d7","width":400,"height":54}},"href":"https://mma.prnewswire.com/media/2939313/Sumitomo_Pharma_updated_Logo_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Orphan drug designation is granted by the FDA to a drug or biological product intended to prevent, diagnose, or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees, and the potential for seven years of market exclusivity after approval.2","length":356,"tagName":"p"},{"type":"text","content":"RP is a rare progressive blinding hereditary condition affecting approximately 1 in 4,000 individuals with very limited, or in many cases, no demonstrated efficacious therapeutic options available. RP first results in loss of night and peripheral vision but ultimately affects central vision in most cases. Although the progression of RP is highly variable among individuals, common pathology includes progressive ...