GenSight Biologics
105 articles about GenSight Biologics
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GenSight Biologics Announces Presentation of LUMEVOQ® Efficacy and Safety Data from Early Access Programs for ND4-LHON Patients at NANOS 2023
3/15/2023
GenSight Biologics announces that efficacy and safety data from patients with Leber Hereditary Optic Neuropathy carrying the ND4 mutation treated with lenadogene nolparvovec through early access programs, were presented at the 49th Annual Meeting of the North American Neuro-Ophthalmology Society.
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GenSight Biologics Confirms Sustained Efficacy and Safety of Bilateral LUMEVOQ® Injections at 3-Year Follow-Up of REFLECT Phase III Trial
3/13/2023
GenSight Biologics, a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, reported topline efficacy and safety results at 3 years post-treatment administration in the REFLECT Phase III clinical trial with LUMEVOQ®.
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GenSight Biologics Announces Publication of LUMEVOQ® Safety Data over 5-Year Period in renowned Peer-Reviewed American Journal of Ophthalmology
3/9/2023
GenSight Biologics announced the publication of a peer-reviewed article in the renowned American Journal of Ophthalmology focusing on pooled safety data from the 5 clinical studies with lenadogene nolparvovec.
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GenSight Biologics Announces 1 Year Safety Data and Efficacy Signals from PIONEER Phase I/II Clinical Trial of GS030, an Optogenetic Treatment Candidate for Retinitis Pigmentosa
2/13/2023
GenSight Biologics announced favorable safety data and encouraging efficacy signals at 1 year post-gene therapy administration for the PIONEER Phase I/II clinical trial evaluating GS030 for the treatment of retinitis pigmentosa in 9 patients, with a follow-up up to 4 years.
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GenSight Biologics reports 5 years’ data showing sustained efficacy and safety following one-time treatment with LUMEVOQ®
7/20/2022
GenSight Biologics reported that after 5 years of follow-up, Leber Hereditary Optical Neuropathy (LHON) subjects treated with LUMEVOQ® (GS010) continued to experience significantly improved vision as a result of a one-time injection of the gene therapy treatment. Compared to the trend in vision observed among untreated patients, the findings are a significant divergence from the natural outcomes of LHON.
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Nanoscope Therapeutics will make two presentations at the 2022 ASRS meeting on their gene therapy programs to treat degenerative retinal diseases, retinitis pigmentosa and Stargardt disease.
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GenSight Biologics Announces Publication of a Study of the Impact of LHON Disease on the Lives of Patients and Relatives in Journal of Neuro-Ophthalmology
5/19/2022
GenSight Biologics announced that the highly-regarded Journal of Neuro-Ophthalmology has published a qualitative study to explore the impact of Leber Hereditary Optic Neuropathy on patients and their relatives.
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GenSight Biologics Reports Clinically Meaningful Vision Improvement is Maintained 4 Years After One-time Treatment with LUMEVOQ® Gene Therapy
1/24/2022
GenSight Biologics, a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, reported that Leber Hereditary Optical Neuropathy subjects treated with LUMEVOQ® continued to experience significantly improved vision four years after a single injection of the gene therapy.
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GenSight Biologics Confirms Sustained Efficacy and Safety of Bilateral LUMEVOQ® Injections at 2-Year Follow-Up of REFLECT Phase III Trial
12/14/2021
GenSight Biologics reported topline efficacy and safety results at 2 years post-treatment administration in the REFLECT Phase III clinical trial with LUMEVOQ®.
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GenSight Biologics Announces Publication of Non-Human Primate Study Reporting Presence of LUMEVOQ® Vector DNA in Contralateral Eyes After Unilateral Injection
12/1/2021
GenSight Biologics, a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announced that the journal Molecular Therapy – Methods and Clinical Development has published the results of a mechanistic study demonstrating the transfer of LUMEVOQ® vector DNA from the injected eyes to the non-injected eyes of non-human primates.
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GenSight Biologics to Host Key Opinion Leader Webcast on Outcomes Among Compassionate Use Patients Treated Bilaterally with LUMEVOQ® in the US
11/22/2021
GenSight Biologics announced that it will host a webcast with Dr. Sean P. Donahue, MD, PhD, of Vanderbilt University on outcomes among six Leber Hereditary Optic Neuropathy patients treated bilaterally with LUMEVOQ® under an FDA-approved compassionate use protocol.
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Biopharma and life sciences companies from across the globe provide updates. Belgium-based Galapagos NV won European approval for Jyseleca for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
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GenSight Biologics Reports Second Patient Case Showing Significant Visual Recovery after GS030 Optogenetic Treatment
11/17/2021
GenSight Biologics, a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, reported a second case of a patient with late-stage retinitis pigmentosa who partially recovered her visual function after treatment with GS030 optogenetic therapy.
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GenSight Biologics to Present New Clinical Data of LUMEVOQ® and GS030 Gene Therapies at the American Academy of Ophthalmology 2021 Meeting
11/12/2021
GenSight Biologics, a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announced that clinical data of LUMEVOQ® and GS030 gene therapies will be presented at the 125th Annual Meeting of the American Academy of Ophthalmology in New Orleans, Louisiana.
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GenSight Biologics Announces FDA Grant of Fast Track Designation for Optogenetic Therapy GS030 as Treatment for Retinitis Pigmentosa
10/12/2021
GenSight Biologics, a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announced that the U.S. Food & Drug Administration has granted Fast Track Designation to GS030, which combines AAV2-based gene therapy with optogenetics to treat Retinitis Pigmentosa.
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GenSight Biologics Announces the Publication of a Review of Gene Therapy Trials for LHON in International Ophthalmology Clinics
10/6/2021
GenSight Biologics, a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announced that the peer-reviewed journal International Ophthalmology Clinics has published a review of current and past gene therapy clinical trials for the treatment of Leber hereditary optic neuropathy.
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GenSight Biologics Announces Positive Data Safety Monitoring Board Review of PIONEER Phase I/II Clinical Trial of GS030 as Optogenetic Treatment for Retinitis Pigmentosa
9/15/2021
GenSight Biologics announced that the independent Data Safety Monitoring Board completed its third safety review of the ongoing PIONEER Phase I/II clinical trial of GS030 combining AAV2-based gene therapy with optogenetics for the treatment of Retinitis Pigmentosa.
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GenSight Biologics Announces Publication Analyzing Visual Parameters of ND4-LHON Subjects Before LUMEVOQ® Treatment in Phase III Trials
9/9/2021
GenSight Biologics announced that the Journal of Neuro-Ophthalmology has published a paper on a cross-sectional analysis of the baseline characteristics of the ND4-LHON subjects enrolled in the RESCUE and REVERSE Phase III trials of LUMEVOQ®.
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UK MHRA Grants GenSight Biologics’ LUMEVOQ® Ophthalmic Gene Therapy Promising Innovative Medicine Designation
9/6/2021
GenSight Biologics announced that its gene therapy LUMEVOQ® has been granted Promising Innovative Medicine designation by the UK’s Medicines and Healthcare products Regulatory Agency for the treatment of vision loss due to Leber Hereditary Optic Neuropathy caused by a confirmed G11778A mutation in the ND4 mitochondrial gene.
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GenSight Biologics Announces Publication of RESTORE Study Data Demonstrating Sustained Efficacy 3 Years After Unilateral Injection of LUMEVOQ®
8/31/2021
GenSight Biologics announced that the Journal of Neuro-Ophthalmology has published results from RESTORE, the long-term follow-up study of LUMEVOQ®, which show sustained treatment effect from a unilateral injection of LUMEVOQ® three years after injection in the RESCUE and REVERSE trials.