Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company based in Iselin, New Jersey, USA, has announced that the UK NICE (National Institute for Health and Care Excellence) has recommended “LYTENAVA” (bevacizumab gamma), as an option for the treatment of wet AMD. The company reports that the ocular treatment “is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the EU and UK and has an initial 10 years of market exclusivity”. Previously, Outlook Therapeutics received regulatory approval in the European Union and the United Kingdom earlier this year for LYTENAVA (bevacizumab gamma). The ophthalmic formulation of bevacizumab was developed to be administered as an intravitreal injection for the treatment of wet AMD and other approved retinal diseases. Since no currently approved ophthalmic formulations of bevacizumab were available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies, products that have risk of contamination and inconsistent potency and availability. LYTENAVA will replace the need to use unapproved repackaged IV bevacizumab from compounding pharmacies for the treatment of wet AMD and the company intend to commercialize product in both vial and pre-filled syringe formulations.
As previously known, bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina. NICE is an executive non-departmental public body responsible for providing guidance on the promotion of good health and the prevention and treatment of ill health in the UK, considering clinical effectiveness and value for money. The NICE recommendation announced applies to England and Wales and follows the recent Marketing Authorization for LYTENAVA (bevacizumab gamma) for the treatment of wet AMD by the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA).
Following the company’s announcement, Professor Tim Jackson, PhD, FRCOphth, Consultant Ophthalmic Surgeon, King’s College Hospital and Professor of Retinal Research, King’s College London, commented, “it is good news that bevacizumab gamma will be available for patients in England and Wales on the NHS. LYTENAVA (bevacizumab gamma) is the first licensed ophthalmic formulation of bevacizumab. Despite not previously being approved for ophthalmic use, bevacizumab has been widely used to treat wet-AMD outside the UK and the approval by NICE marks significant progress towards ophthalmologists being able to use licensed bevacizumab for wet AMD in the UK. Importantly, the licensing process puts in place a number of quality controls, and combined with reduced cost, this should provide a welcome, cost-effective treatment option for our patients.”
Professor Tim Jackson PhD, MB ChB, FRCOphth, is a Consultant Ophthalmic & Retinal Surgeon with a specialist interest in age-related macular degeneration, diabetes and cataract surgery. He has subspecialty expertise in vitreoretinal surgery and medical retina.
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