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- ||||||| Lytenava (bevacizumab-vikg) / Outlook Therap
Trial completion: NORSE EIGHT: A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Feb 26, 2025
P3, N=400, Completed, Sponsor: Outlook Therapeutics, Inc.
Active, not recruiting --> Completed
- | Lytenava (bevacizumab-vikg) / Outlook Therap
Journal: ONS-5010 (bevacizumab-vikg) Safety and Efficacy in Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration. (Pubmed Central) - Nov 14, 2024
Bevacizumab and ranibizumab displayed a comparable safety profile. [Ophthalmic Surg Lasers Imaging Retina 2024;55:XX-XX.].
- Lytenava (bevacizumab-vikg) / Outlook Therap
Incidence of Anti-VEGF Intravitreal Injections for Non–FDA Approved Indications (DEMAND) - Sep 24, 2024 - Abstract #AAO2024AAO_2426;
[Ophthalmic Surg Lasers Imaging Retina 2024;55:XX-XX.]. Conclusion A significant number of patients received anti-VEGF injections for non
- ||||| Lytenava (bevacizumab-vikg) / Outlook Therap
Enrollment closed: NORSE EIGHT: A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Sep 20, 2024
P3, N=400, Active, not recruiting, Sponsor: Outlook Therapeutics, Inc.
Conclusion A significant number of patients received anti-VEGF injections for non Recruiting --> Active, not recruiting
- ||| Lytenava (bevacizumab-vikg) / Outlook Therap
Trial completion date, Trial primary completion date: NORSE SEVEN: A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders (clinicaltrials.gov) - Apr 4, 2024
P3, N=120, Active, not recruiting, Sponsor: Outlook Therapeutics, Inc.
Recruiting --> Active, not recruiting Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
- |||||| Lytenava (bevacizumab-vikg) / Outlook Therap
Enrollment open: NORSE EIGHT: A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Jan 25, 2024
P3, N=400, Recruiting, Sponsor: Outlook Therapeutics, Inc.
Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025 Not yet recruiting --> Recruiting
- |||||||||| Lytenava (bevacizumab-vikg) / Outlook Therap
New P3 trial: NORSE EIGHT: A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Jan 3, 2024
P3, N=400, Not yet recruiting, Sponsor: Outlook Therapeutics, Inc.
- ||| Lytenava (bevacizumab-vikg) / Outlook Therap
Trial completion date, Trial primary completion date: NORSE SEVEN: A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders (clinicaltrials.gov) - Mar 30, 2023
P3, N=120, Active, not recruiting, Sponsor: Outlook Therapeutics, Inc.
Not yet recruiting --> Recruiting Trial completion date: Dec 2022 --> Mar 2024 | Trial primary completion date: Dec 2022 --> Mar 2024
- ||| Lytenava (bevacizumab-vikg) / Outlook Therap
PDUFA date: $OTLK FDA accepts BLA for for ONS-5010 as a Treatment for Wet AMD. PDUFA 08/29/23 (Twitter) - Oct 28, 2022
- || Lytenava (bevacizumab-vikg) / Outlook Therap
$OTLK Re-Submits BLA for ONS-5010 as a Treatment for Wet AMD (Twitter) - Aug 30, 2022
- || Lytenava (bevacizumab-vikg) / Outlook Therap
BLA: $OTLK reiterates expected re-submission of BLA for ONS-5010 by September following receipt of additional correspondence from the FDA (Twitter) - Jun 14, 2022
- ||| Lytenava (bevacizumab-vikg) / Outlook Therap
BLA: $OTLK $OTLKW Outlook Therapeutics Confirms Status of Biologics License Application (BLA) Submission for ONS-5010 https://t.co/4gKEdXx8CI (Twitter) - Jun 14, 2022
- |||| Lytenava (bevacizumab-vikg) / Outlook Therap
Enrollment closed: NORSE SEVEN: A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders (clinicaltrials.gov) - Dec 6, 2021
P3, N=120, Active, not recruiting, Sponsor: Outlook Therapeutics, Inc.
Trial completion date: Dec 2022 --> Mar 2024 | Trial primary completion date: Dec 2022 --> Mar 2024 Recruiting --> Active, not recruiting
- |||| Lytenava (bevacizumab-vikg) / Outlook Therap
Enrollment open: NORSE SEVEN: A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders (clinicaltrials.gov) - Nov 25, 2021
P3, N=120, Recruiting, Sponsor: Outlook Therapeutics, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||||| Lytenava (bevacizumab-vikg) / Outlook Therap
New P3 trial: NORSE SEVEN: A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders (clinicaltrials.gov) - Nov 8, 2021
P3, N=120, Not yet recruiting, Sponsor: Outlook Therapeutics, Inc.
- Lytenava (bevacizumab ophthalmic) / Outlook Therap
Safety and Efficacy Results of ONS-5010, An Ophthalmic Bevacizumab, from Phase 3 Study of Monthly Intravitreal ONS-5010 In Subjects with Wet AMD (NORSE 2) (Morial Convention Center; THE GREAT HALL) - Oct 20, 2021 - Abstract #AAO2021AAO_467;
- || Avastin (bevacizumab) / Roche, Lytenava (bevacizumab ophthalmic) / Outlook Therap
Ophthalmic Bevacizumab Sponsor Braces For High-Stakes EMA Meeting https://t.co/VuLufw8iDl #PinkSheet (Twitter) - Oct 11, 2021
- ||||||| Lytenava (bevacizumab-vikg) / Outlook Therap
Trial completion: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Aug 13, 2021
P3, N=227, Completed, Sponsor: Outlook Therapeutics, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || Avastin (bevacizumab) / Roche, Lucentis (ranibizumab) / Roche, Novartis
Clinical, Retrospective data, Journal: Incidence of endophthalmitis following intravitreal anti VEGF injections at a tertiary care hospital in Pakistan. (Pubmed Central) - Jun 22, 2021
Active, not recruiting --> Completed The institutional procedure protocol was found to be effective as the rate of infectious endophthalmitis was lower than what is reported in literature.
- ||| Avastin (bevacizumab) / Roche, Lytenava (bevacizumab ophthalmic) / Outlook Therap
Review: Ophthalmic Bevacizumab Reaches Critical Review Stage In EU https://t.co/r3VlIU6lEF #PinkSheet (Twitter) - Jun 17, 2021
- | Avastin (bevacizumab) / Roche
Journal: All India Ophthalmological Society members' survey: Practice pattern of intravitreal anti-vascular endothelial growth factor injection. (Pubmed Central) - May 15, 2021
There is no uniform protocol for aliquoting bevacizumab. Single use bevacizumab vial for exclusive ophthalmic use will further improve the safety of the procedure.
- ||||| Lytenava (bevacizumab-vikg) / Outlook Therap
Trial completion: A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders (clinicaltrials.gov) - Apr 28, 2021
P3, N=195, Completed, Sponsor: Outlook Therapeutics, Inc.
Single use bevacizumab vial for exclusive ophthalmic use will further improve the safety of the procedure. Active, not recruiting --> Completed
- || Avastin (bevacizumab) / Roche
Clinical, Journal: Incidence of Acute Endophthalmitis After Intravitreal Bevacizumab Injection at a Tertiary Care Hospital in Lahore. (Pubmed Central) - Mar 16, 2021
Active, not recruiting --> Completed Incidence of acute endophthalmitis following intravitreal bevacizumab injection was low and could be prevented by taking strict aseptic measures during administration.
- | Avastin (bevacizumab) / Roche
Journal: Outcome of intravitreal bevacizumab injection without pre and postoperative antibiotics. (Pubmed Central) - Mar 6, 2021
Intravitreal injection can be given safely without pre-operative and post-operative antibiotics. Trial Registration not applicable as it is a retrospective study.
- |||| Lytenava (bevacizumab-vikg) / Outlook Therap
Enrollment closed: A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders (clinicaltrials.gov) - Nov 3, 2020
P3, N=195, Active, not recruiting, Sponsor: Outlook Therapeutics, Inc.
Trial Registration not applicable as it is a retrospective study. Recruiting --> Active, not recruiting
- |||| Lytenava (bevacizumab-vikg) / Outlook Therap
Enrollment open: A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders (clinicaltrials.gov) - Oct 5, 2020
P3, N=180, Recruiting, Sponsor: Outlook Therapeutics, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||||| Lytenava (bevacizumab-vikg) / Outlook Therap
Trial completion: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Sep 15, 2020
P3, N=61, Completed, Sponsor: Outlook Therapeutics, Inc.
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- |||||||| Lytenava (bevacizumab-vikg) / Outlook Therap
New P3 trial: A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders (clinicaltrials.gov) - Aug 17, 2020
P3, N=180, Not yet recruiting, Sponsor: Outlook Therapeutics, Inc.
- | Avastin (bevacizumab) / Roche
Journal: LONG-TERM PHYSICAL STABILITY, STERILITY, AND ANTI-VEGF BIOACTIVITY OF REPACKAGED BEVACIZUMAB IN 2-ML GLASS VIALS. (Pubmed Central) - Jul 29, 2020
Bevacizumab can be repackaged into small, single-dose glass vials for intravitreal injection and the qualities of the commercial product maintained, including anti-VEGF bioactivity, for up to 21 months in refrigerated storage. Consideration should be given to repackaging bevacizumab for ophthalmic use in small glass vials as opposed to plastic syringes.
- ||||| Lytenava (bevacizumab-vikg) / Outlook Therap
Enrollment closed, Trial completion date, Trial primary completion date: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Jul 8, 2020
P3, N=227, Active, not recruiting, Sponsor: Outlook Therapeutics, Inc.
Consideration should be given to repackaging bevacizumab for ophthalmic use in small glass vials as opposed to plastic syringes. Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Jul 2021 | Trial primary completion date: Nov 2020 --> Jun 2021
- | Lytenava (bevacizumab-vikg) / Outlook Therap
Enrollment closed: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Aug 26, 2019
P3, N=61, Active, not recruiting, Sponsor: Outlook Therapeutics, Inc.
Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> Jul 2021 | Trial primary completion date: Nov 2020 --> Jun 2021 Recruiting --> Active, not recruiting
- | Lytenava (bevacizumab-vikg) / Outlook Therap
Enrollment open: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Jun 26, 2019
P3, N=220, Recruiting, Sponsor: Outlook Therapeutics, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Lytenava (bevacizumab-vikg) / Outlook Therap
Trial initiation date: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Jun 6, 2019
P3, N=220, Not yet recruiting, Sponsor: Outlook Therapeutics, Inc.
Not yet recruiting --> Recruiting Initiation date: Mar 2019 --> Jun 2019
- | Lytenava (bevacizumab-vikg) / Outlook Therap
Trial completion date, Trial primary completion date: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Jun 6, 2019
P3, N=60, Recruiting, Sponsor: Outlook Therapeutics, Inc.
Initiation date: Mar 2019 --> Jun 2019 Trial completion date: Mar 2020 --> Jun 2020 | Trial primary completion date: Jan 2020 --> May 2020
- | bevacizumab ophthalmic (ONS-5010) / Outlook Therap
$OTLK Manufacturing Supply Agreement With FUJIFILM Diosynth Biotechnologies As Part Of Commercialization Strategy For ONS-5010 https://t.co/0vrgnfRWcE (Twitter) - Jun 3, 2019
- | Lytenava (bevacizumab-vikg) / Outlook Therap
New P3 trial: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Feb 18, 2019
P3, N=60, Recruiting, Sponsor: Outlook Therapeutics, Inc.
- | Lytenava (bevacizumab-vikg) / Outlook Therap
New P3 trial: A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - Feb 8, 2019
P3, N=180, Not yet recruiting, Sponsor: Outlook Therapeutics, Inc.