Munich – Formycon AG, the biosimilars company, today announced that it has filed already three patent applications relating to the formulation and intraocular delivery of VEGF antagonists. The first international patent application related to a silicone-free pre-filled plastic syringe has been recently published (International Publication Number WO 2015/173260 Al).
VEGF antagonists ranibizumab and aflibercept are commonly used to treat age dependent eye diseases such as wet macular degeneration. The market size for intraocular anti-VEGF therapy is rapidly increasing with a current volume of about USD 6.9 billion.
Pre-filled syringes have many benefits compared to a vial and a separately provided syringe, such as improved convenience, safety, accuracy, sterility, and affordability. The use of pre-filled syringes results in greater dose precision, in a reduction of the potential for needle stick injuries that can occur while drawing medication from vials, in pre-measured dosage reducing dosing errors and sterility problems due to the need to reconstitute medication or draw it into a syringe, and in less overfilling of the syringe helping to reduce costs by minimising drug waste.
Silicone-free prefilled plastic syringes containing a VEGF antagonist will present an innovative way of drug administration for intraocular injection. Compared to glass syringes this new injection technology offers the potential for improved safety and convenience for patients and healthcare professionals as they are resistant to breakage and have a lower weight. Furthermore, it has been shown that silicone oil from standard glass or plastic syringes might migrate into the drug solution, cause drug inactivation, and accumulates in the vitreous cavity after intravitreal administration of VEGF antagonists.
Dr. Carsten Brockmeyer, CEO of Formycon AG, said “We are pleased to provide a potential improved way to accurately and safely administer VEGF antagonist in the eye. Our patent applications cover a broad range of VEGF antagonist formulations and injection devices. This underlines our mission to develop high quality biosimilars to treat eye diseases, one of the most rapidly growing therapeutic areas.”
Formycon and its license partner bioeq GmbH, Holzkirchen, Germany, recently announced the initiation of a pivotal Phase III clinical trial with FYB201, an investigational biosimilar ranibizumab (Lucentis®*).
* Lucentis is a registered trademark of Genentech Inc.