Outlook Therapeutics
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2011-01-01
- Employees
- 24
- Market Cap
- $176.7M
- Introduction
Outlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of ONS-5010/LYTENAVA. Its pipeline includes unmet patient needs, repackaged IV bevacizumab, and anti-VEGF. The company was founded by Pankaj Mohan on January 5, 2010 and is headquartered in Iselin, NJ.
Clinical Trials
5
Trial Phases
1 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
This company may not have drug approvals in our database
Clinical Trials
Distribution across different clinical trial phases (5 trials with phase data)• Click on a phase to view related trials
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
- Conditions
- Wet Macular DegenerationAge-Related Macular DegenerationNeovascular Age-related Macular Degeneration
- Interventions
- First Posted Date
- 2024-01-05
- Last Posted Date
- 2025-02-25
- Lead Sponsor
- Outlook Therapeutics, Inc.
- Target Recruit Count
- 400
- Registration Number
- NCT06190093
- Locations
- 🇺🇸
Clinical Site, Silverdale, Washington, United States
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
- Conditions
- Age-Related Macular DegenerationWet Macular DegenerationNeovascular Age-related Macular DegenerationBRVO - Branch Retinal Vein OcclusionDiabetic Macular Edema
- First Posted Date
- 2021-11-09
- Last Posted Date
- 2024-04-02
- Lead Sponsor
- Outlook Therapeutics, Inc.
- Target Recruit Count
- 120
- Registration Number
- NCT05112861
- Locations
- 🇺🇸
Clinical Site, Chambersburg, Pennsylvania, United States
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
- Conditions
- Neovascular Age-related Macular DegenerationBRVO - Branch Retinal Vein OcclusionAge-related Macular DegenerationWet Macular DegenerationDiabetic Macular Edema
- Interventions
- First Posted Date
- 2020-08-18
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- Outlook Therapeutics, Inc.
- Target Recruit Count
- 195
- Registration Number
- NCT04516278
- Locations
- 🇺🇸
Clinical Site, Willow Park, Texas, United States
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
- Conditions
- Neovascular Age-related Macular DegenerationWet Macular DegenerationAge-related Macular Degeneration
- Interventions
- First Posted Date
- 2019-02-18
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- Outlook Therapeutics, Inc.
- Target Recruit Count
- 61
- Registration Number
- NCT03844074
- Locations
- 🇦🇺
Clinical Site, Glen Waverley, Victoria, Australia
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)
- Conditions
- Wet Macular DegenerationNeovascular Age-related Macular DegenerationAge-related Macular Degeneration
- Interventions
- First Posted Date
- 2019-02-08
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- Outlook Therapeutics, Inc.
- Target Recruit Count
- 228
- Registration Number
- NCT03834753
- Locations
- 🇺🇸
Clinical Site, Madison, Wisconsin, United States
News
Outlook Therapeutics Awaits Critical FDA Decision for Wet AMD Treatment ONS-5010
Outlook Therapeutics' stock surged 11.97% in pre-market trading on August 18, 2025, as investors anticipate the FDA's decision on ONS-5010 (LYTENAVA) scheduled for August 27, 2025.
Q3 2025 Biopharma Catalyst Monitor Highlights 18 Key FDA Decisions and Clinical Trial Milestones
A new quarterly report identifies 18 significant biopharma catalyst events expected in Q3 2025, including FDA approval decisions for multiple companies across diverse therapeutic areas.
Outlook Therapeutics Approaches Critical FDA Decision for LYTENAVA as European Launch Validates Market Potential
Outlook Therapeutics awaits FDA decision by August 27, 2025, for LYTENAVA (bevacizumab-vikg), which would be the first FDA-approved ophthalmic formulation of bevacizumab in the U.S. with 12 years of regulatory exclusivity.
Outlook Therapeutics Launches First Approved Ophthalmic Bevacizumab in Europe for Wet AMD Treatment
Outlook Therapeutics has commercially launched LYTENAVA™ (bevacizumab gamma) in Germany and the UK, marking the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment in Europe.
Outlook Therapeutics' ONS-5010 BLA Resubmission Progresses Amid Price Target Adjustment
Guggenheim maintains Buy rating on Outlook Therapeutics while adjusting price target from $12 to $10 following fiscal Q1 earnings report.
Outlook Therapeutics' ONS-5010 Shows Non-Inferiority to Ranibizumab in Wet AMD Trial
Outlook Therapeutics' ONS-5010 demonstrated non-inferiority to ranibizumab (Lucentis) at week 12 in the NORSE EIGHT trial for wet AMD.
LYTENAVA Receives NICE Recommendation for Wet AMD Treatment in the UK
LYTENAVA (bevacizumab gamma) has been recommended by NICE for treating wet AMD, marking the first positive reimbursement decision worldwide for this ophthalmic formulation.
Outlook Therapeutics Announces Executive Leadership Transition
Russell Trenary has stepped down as President and CEO of Outlook Therapeutics, effective immediately, after the company achieved EU and UK regulatory approval for LYTENAVA™.
Outlook Therapeutics Faces Setback in AMD Trial; Other R&D Updates
Outlook Therapeutics' ONS-5010 failed to meet the noninferiority endpoint in a Phase III wet AMD trial, impacting company shares but BLA resubmission is still planned for early 2025.
Outlook Therapeutics' Lytenava Fails to Meet Endpoint in Phase III Wet AMD Trial
Outlook Therapeutics' Lytenava (bevacizumab-vikg) did not meet the pre-specified non-inferiority endpoint in the NORSE EIGHT Phase III trial for wet AMD at eight weeks.