Swiss company Novartis reported Dec. 22 that it had agreed to acquire UK-based ophthalmic gene therapy company Gyroscope Therapeutics. Gyroscope has been developing GT005, an AAV2-based one-time gene therapy candidate in Phase II study for the treatment of geographic atrophy. GT005 aims to restore balance to an overactive complement system by increasing production of the Complement Factor I protein to …
US FDA Accepts Ocugen’s IND for Retinal Gene Therapy Candidate
Ocugen announced Dec. 9 that the US FDA had accepted the company’s investigational new drug (IND) application to initiate a first-in-human Phase I/II trial of its gene therapy candidate for retinitis pigmentosa (RP).
GenSight Biologics Confirms Sustained Efficacy and Safety of Bilateral Lumevoq Injections at 2-Year Follow-Up of REFLECT Phase 3 Trial
GenSight Biologics reported topline efficacy and safety results at 2 years post-treatment administration in the REFLECT Phase 3 clinical trial with Lumevoq. The results show sustained efficacy and safety for bilateral intravitreal injection of the gene therapy, including better efficacy compared to unilateral injection.
Sanofi to Invest up to $60 Million in Gyroscope Therapeutics
UK-based Gyroscope Therapeutics announced Nov. 8 that France’s Sanofi had committed to invest up to $60 million in equity in Gyroscope. Sanofi will invest $40 million initially, at a premium to Gyroscope’s prior Series C financing, and the remaining $20 million will be contingent on a future qualifying investment round and subject to certain closing conditions. Under the agreement, a …
US FDA Clears IND for 4DMT’s Wet AMD Gene Therapy Candidate
4D Molecular Therapeutics announced Oct. 6 that the US FDA had cleared the investigational new drug application (IND) for 4D-150 for wet age-related macular degeneration (wet AMD). 4D-150 is a dual-transgene intravitreal gene therapy that targets four distinct angiogenic factors, which 4DMT says has the potential for broad and durable efficacy after a single intravitreal administration in patients with wet …
Adverum Presents Data Showing Gene Therapy Maintained Efficacy, Durability, Safety in Wet AMD Patients
Adverum Biotechnologies announced new long-term data from the OPTIC clinical trial of ADVM-022 single, in-office intravitreal (IVT) injection gene therapy in patients requiring frequent anti-VEGF injections for their wet age-related macular degeneration (AMD). Safety and efficacy data from patients followed through 2 years post injection are being presented at the Retina Society’s 54th Annual Scientific Meeting in Chicago. The presentation is available on …
Eyevensys Enters Collaboration with Phillips-Medisize and Minnetronix Medical
Eyevensys has entered into strategic engagements with US-based medical device manufacturers Phillips-Medisize and Minnetronix Medical to develop the next generation of the company’s core technology. Terms of the deal were not diclosed. Eyevensys has developed a non-viral gene therapy ocular drug delivery platform with a proprietary Electrotransfection System designed to deliver DNA plasmids encoding therapeutic proteins into the ciliary muscle and sustainably treat major eye diseases. …
Novartis Acquires Arctos Medical, Expanding Optogenetic Gene Therapy Pipeline
Swiss company Novartis announced Sept. 21 that it had acquired Arctos Medical, developer of a potential optogenetic AAV gene therapy for inherited retinal disease. Financial details were not disclosed. The move comes a year after Novartis paid $150 million up front and a potential $130 million in milestone payments in September 2020 for Vedere Bio of Cambridge, Massachusetts.
AbbVie Makes Large Investment in Regenxbio’s Gene Therapy for Retinal Diseases
AbbVie and Regenxbio announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (AMD), diabetic retinopathy (DR), and other chronic retinal diseases. RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate …
MeiraGTx Announces Data at EURETINA 2021 Demonstrating Reversal of Disease Progression Following Treatment With AAV5-RPGR in XLRP
MeiraGTx Holdings announced new data from subjects treated in the phase 1/2 dose escalation phase of Study MGT009 indicating AAV5-RPGR, an investigational gene therapy in development for the treatment of X-linked retinitis pigmentosa (XLRP), reverses course of disease progression when retinal function assessed 12 months following treatment with AAV5-RPGR is compared with retinal function in these same subjects up to …
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