Santen Pharmaceutical Co. Ltd. is selling its North American branded ophthalmic portfolio to Visiox Pharma LLC and Harrow Health Inc. in a move to make its global organization as competitive as possible, Santen told BioWorld.
Astellas Pharma Inc. and 4D Molecular Therapeutics Inc. (4DMT) inked a deal worth up to $942 million under which Astellas will license 4DMT's intravitreal R100 gene therapy vector for rare ophthalmic targets.
Japan’s Pharmaceutical and Medical Devices Agency has cleared Healios K.K. and Sumitomo Pharma Co. Ltd. to begin a phase I/II study of HLCR-011, which is composed of retinal pigment epithelial (RPE) cells derived from allogeneic induced pluripotent stem cells (iPS) in patients with RPE tear.
Hanall Biopharma Co. Ltd.’s phase III trial VELOS-3 of tanfanercept did not show effects on the central cornea of the eye or in eye dryness in the treatment of moderate to severe dry eye disease, the primary endpoints. Data from the trial did show improvements in tear production, a secondary endpoint.
Astellas Pharma Inc. announced it plans to acquire Iveric Bio Inc. in an all-cash deal in which it will pay $40 per Iveric share for a total equity value of roughly $5.9 billion. “Iveric Bio has promising programs including avacincaptad pegol (Zimura), an important program for geographic atrophy secondary to age-related macular degeneration, and capabilities across the entire value chain in the ophthalmology field,” said Naoki Okamura, Astellas’ president and CEO.
PYC Therapeutics Ltd.’s lead candidate, VP-001, is entering the clinic, and the RNA therapy could be the first potential treatment for retinitis pigmentosa type 11, which causes blindness that begins in childhood and ultimately leads to legal blindness by middle age.
Japan’s PMDA has approved Aurion Biotech Inc.’s cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea, making it the first-ever approval of a cell therapy to treat corneal endothelial disease.
Ophthalmic startup Eluminex Biosciences Ltd. closed a $40 million series B round to progress its pipeline of ophthalmic assets and recombinant human collagen technology. Eluminex’s pipeline includes multi-targeted antibody molecules for vision-threatening retinal diseases and an oral small molecule for rare inherited pediatric retinal dystrophies, but its lead asset, EB-301, is a biosynthetic cornea derived from recombinant human type III collagen.
Shares of Oyster Point Pharma Inc. (NASDAQ:OYST) soared to $11.57, or 38.6% on word of the buyout by Viatris Inc., which is also taking over privately held, development-stage Famy Life Sciences Ltd. to create an ophthalmology franchise that Viatris estimates could mean at least $1 billion in sales by 2028 as well as at least $500 million more in adjusted EBITDA.
The U.S. FDA approved Santen Pharmaceutical Co. Ltd.’s and UBE Industries Ltd.’s Omlonti (omidenepag isopropyl) ophthalmic solution for reducing elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. It is the second FDA-approved product from Japan-based Santen in the last 15 months for patients in the U.S. with vision conditions.