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.
Exonate Ltd. is preparing to advance its eye drop candidate to treat retinal vascular diseases, EXN-407, into a phase IIb study following promising tolerability and early signs of efficacy in a phase Ib/IIa study. A small-molecule SRPK1 inhibitor, EXN-407 is designed to be administered twice daily and works by selectively targeting specific (proangiogenic) isoforms of VEGF that lead to vascular retinal disease progression via aberrant growth of leaky blood vessels within the eye.
With its sights set on expanding the commercial launch of Xdemvy (lotilaner ophthalmic solution, 0.25%) to treat Demodex blepharitis in the U.S., Tarsus Pharmaceuticals Inc. has priced an underwritten public offering of common stock, selling 2.8 million shares for $32 each, taking the expected gross proceeds to about $100 million.
Ocular gene therapy specialist Pulsesight Therapeutics SAS has launched with seed funding and is raising a series A to take forward two programs using electroporation to deliver plasmid DNA in the treatment of wet age-related macular degeneration and geographic atrophy.
After trading as low as $2.04, shares of Palatin Technologies Inc. (NYSE:PTN) closed Feb. 28 down $1.57, or 39.7%, ending at $2.39 on word of results from the phase III pivotal Melody-1 trial with melanocortin pan-agonist PL-9643 vs. vehicle in dry eye disease.
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.
With Adverum Biotechnologies Inc.’s preliminary safety and efficacy data made public from the ongoing Luna phase II trial testing gene therapy ixoberogene soroparvovec (ixo-vec) in wet age-related macular degeneration (AMD), Wall Street promptly began stacking the results against those of competitors. CEO Laurent Fischer pointed out that ixo-vec boasts the “highest rate of injection-free patients of any study of any program at any dose.”
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.
4DMT Molecular Therapeutics Inc. is looking ahead to phase III as positive data continue to roll out for gene therapy candidate 4D-150 in wet age-related macular degeneration (AMD), with the results from the phase II portion of the phase I/II Prism trial showing the single-shot treatment significantly reduced the need for chronic anti-VEGF injections. Presented over the weekend at the Angiogenesis, Exudation, and Degeneration 2024 Conference, results from the 24-week dose-expansion cohort, which comprised wet AMD patients with severe disease and high treatment burdens, showed patients receiving the high dose (3E10 vg/eye) had a 90% reduction in annualized anti-VEGF injection rates.
Kiora Pharmaceuticals Inc.’s development and commercialization deal with Théa Open Innovation (TOI), a sister company of Laboratoires Théa, for KIO-301 in degenerative retinal diseases “takes a bit of an industry-standard type of approach” in terms of structure, said CEO Brian Strem.
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