On the heels of a $4.6 million series A round in December 2023, cell therapy company Rxcell Inc. is planning to raise another $15 million in 2024 to take its iPSC-derived photoreceptors to the clinic for retinitis pigmentosa and other degenerative diseases of the retina.
PYC Therapeutics raised AU$40 million of an anticipated AU$74 million (US$48.6 million) capital raise to advance three candidates, including lead candidate VP-001, which could potentially be the first treatment for retinitis pigmentosa type 11 (RP11), which causes blindness that begins in childhood and ultimately leads to legal blindness by middle age.
Taiwan’s Formosa Pharmaceuticals Inc. and Aimmax Therapeutics, Inc. said the U.S. FDA approved APP-13007 (clobetasol propionate ophthalmic suspension 0.05%), a twice-daily corticosteroid eye drop for postoperative eye pain and inflammation.
In a crowded thyroid eye disease (TED) space, Innovent Biologics Inc. reported positive late-stage findings for its TED therapy, IBI-311, spurring the Suzhou, China-based biopharma to file for regulatory approval in China.
Korean bioventure Curacle Co. Ltd. reported positive top-line findings from its U.S.-based phase IIa study of CU06-1004, an oral drug for diabetic macular edema, spurring plans for a bigger phase IIb study in the second half of 2024.
Vision Care Group CEO Masayo Takahashi led the world's first clinical study of a retinal cell transplant derived from induced pluripotent stem cells (iPS cells) in 2014 when she led the Laboratory for Retinal Regeneration at Japan’s Riken Center for Biosystems Dynamics Research. In 2019, she founded Vision Care and subsequently founded two subsidiary companies dedicated to developing cell and gene therapies.
Lianbio Co. Ltd. announced mixed phase III top-line results on Oct. 30 for its in-licensed Demodex blepharitis treatment called TP-03, with the U.S. FDA-approved eyedrop hitting just one co-primary endpoint in the Libra trial on Chinese patients.
A nonsteroidal eye drop formulation of dazdotuftide, TRS-01 missed its late-stage primary endpoint for controlling inflammation in uveitis, but developer Tarsier Pharma Ltd. said post-hoc analysis showing a boosted benefit-risk profile over steroids may be a ray of hope.
Opthea Ltd. plans to raise AU$80 million (US$51.2 million) via a AU$10 million private placement and a AU$70 million entitlement offer to continue its pivotal phase III trials in wet age-related macular degeneration (wet AMD) for lead candidate OPT-302.
Iveric Bio Inc. is now the second biotech to gain U.S. clearance for geographic atrophy – snagging U.S. FDA approval on Aug. 4 for Izervay (avacincaptad pegol intravitreal solution) to treat GA secondary to age-related macular degeneration. The once-monthly Izervay 2-mg injection is anticipated to be available in the U.S. in two to four weeks, said Tokyo-based Astellas Pharma Inc., which recently acquired Iveric in May 2023.