DUBLIN – The contest to bring a safe and effective gene therapy for X-linked retinitis pigmentosa (XLRP) to market is intensifying. Two of the three contenders with clinical-stage programs reported initial 12-month data from phase I/II trials and are now looking ahead to pivotal trials and beyond.
Aurinia Pharmaceuticals Inc. is suspending further development of voclosporin ophthalmic solution (VOS) for dry eye syndrome after a dose-ranging trial of the candidate failed to meet its primary endpoint of improving a measure of the condition after four weeks of treatment.
Ocular Therapeutix Inc. and Affamed Therapeutics Ltd. entered a license and collaboration agreement to develop and commercialize Dextenza and OTX-TIC in greater China, South Korea and the Association of Southeast Asian Nations markets.
Novartis AG is expanding its position in the optogenetics space with the acquisition of Vedere Bio Inc., bringing with it a program aimed at vision loss prevention and treatment. Shareholders of Vedere, created in June 2019 through the Atlas Venture incubator, received $150 million up front and are eligible for up to $130 million in milestone payments, bringing the total to $280 million.
Miragen Therapeutics Inc. gained ground lost on Wall Street earlier this month and then some, with shares (NASDAQ:MGEN) closing at $1.26, up 74 cents or 142% after the company disclosed plans to take over Viridian Therapeutics Inc., conducting at the same time a private placement that will raise $91 million.
PERTH, Australia – Opthea Ltd. completed a $128.2 million IPO on the U.S. Nasdaq market, which will fund two phase III trials in wet age-related macular degeneration (AMD) and bring the company’s lead candidate, OPT-302, to market if successful.
Kala Pharmaceuticals Inc.’s anticipated win with Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease (DED) didn’t help shares (NASDAQ:KALA), which closed Oct. 27 at $6.28, down $1.44, or 18.7%, on word of the FDA approval.
PERTH, Australia – Azura Ophthalmics Ltd. raised a $20 million series C round with existing investors, including Brandon Capital’s Medical Research Commercialization Fund (MRCF), Orbimed, TPG Biotech and Ganot Capital.
LONDON – Sparingvision SAS has raised €44.5 million (US$52.5 million) to advance SPVNo6, a gene therapy designed to be effective for all retinitis pigmentosa patients regardless of the underlying mutation, with a phase I dose-ranging study now due to start in 2021.
Earlier this month, an update on phase I/IIa data rolled out from Rockville, Md.-based Regenxbio Inc. with RGX-314 for age-related wet macular degeneration (AMD). The company has a pivotal program in subretinal delivery of the compound set to start by the end of this year, and questions about routes of administration – always an issue in AMD – continue to simmer.
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