Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) for the treatment of retina diseases, including wet AMD. The company aims to redefine the standard of care for retinal diseases by providing FDA-approved ophthalmic formulations of bevacizumab, addressing unmet medical and social needs, and ensuring high safety and quality standards. Their mission is to deliver quality and accessibility in retinal care, with a vision to help all patients with retinal disease envision a brighter world.
Industries
Nr. of Employees
small (1-50)
Outlook Therapeutics, Inc.
111 S. Wood Ave, Unit #100, Iselin, NJ 08830
Patents
Products
Investigational ophthalmic anti‑VEGF formulation (intravitreal biologic)
An ophthalmic formulation of a full‑length anti‑VEGF monoclonal antibody developed for intravitreal injection to treat retinal diseases such as neovascular AMD, diabetic macular edema and branch retinal vein occlusion.
Investigational ophthalmic anti‑VEGF formulation (intravitreal biologic)
An ophthalmic formulation of a full‑length anti‑VEGF monoclonal antibody developed for intravitreal injection to treat retinal diseases such as neovascular AMD, diabetic macular edema and branch retinal vein occlusion.
Services
Design and execution of Phase 1–3 clinical studies for intravitreal biologics, including randomized controlled trials, safety studies and multi‑site trial operations.
Preparation and management of biologics regulatory filings, agency interactions, SPA negotiations and responses to regulatory questions related to clinical and CMC matters.
CMC and GMP manufacturing planning, quality systems for sterility and stability, and supply agreements for pre‑filled ophthalmic syringes to support product safety and clinician usability.
Systems and processes for adverse event reporting, safety database maintenance and regional safety contacts to support clinical development and post‑marketing safety obligations.
Design and execution of Phase 1–3 clinical studies for intravitreal biologics, including randomized controlled trials, safety studies and multi‑site trial operations.
Preparation and management of biologics regulatory filings, agency interactions, SPA negotiations and responses to regulatory questions related to clinical and CMC matters.
CMC and GMP manufacturing planning, quality systems for sterility and stability, and supply agreements for pre‑filled ophthalmic syringes to support product safety and clinician usability.
Systems and processes for adverse event reporting, safety database maintenance and regional safety contacts to support clinical development and post‑marketing safety obligations.
Expertise Areas
- Ophthalmic biologics development
- Clinical trial management for retinal diseases
- Regulatory strategy for biologics (BLA, EMA, MHRA interactions)
- CMC and GMP manufacturing for ophthalmic products
Key Technologies
- Monoclonal antibody therapeutics
- Intravitreal drug delivery
- Pre‑filled ophthalmic syringe drug‑delivery devices
- Pharmacokinetic (PK) and bioequivalence assays