Ocular Therapeutix Announces Termination of Collaboration with Regeneron on Sustained-Release Aflibercept for Wet AMD

Compiled by: Fan Dongdong

Recently, Ocular Therapeutix and Regeneron announced the termination of their collaboration and the suspension of development of an aflibercept sustained-release formulation for the treatment of wet age-related macular degeneration (AMD) and other serious retinal diseases. The termination decision took effect on August 5, 2021.

Ocular is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for ocular diseases and conditions. In 2016, the company entered into a collaboration with Regeneron for ophthalmic therapies. Under the collaboration agreement, Regeneron will leverage Ocular’s hydrogel technology to develop and commercialize extended-release formulations of aflibercept and other VEGF-targeted drugs for ophthalmic indications. Furthermore, Ocular will retain all rights to develop non-VEGF-targeted compounds and small molecule drugs (including TKIs) for the treatment of other retinal diseases based on its hydrogel sustained-release drug delivery platform. Pursuant to a 2020 amendment, the collaboration between Ocular and Regeneron will focus on the research and development of extended-dosing formulations of aflibercept.

Ocular Therapeutix President and Chief Executive Officer Antony Mattessich stated, "While we deeply regret ending the collaboration, Ocular is highly appreciative of the opportunity to partner with Regeneron on the development of aflibercept. This collaboration has the potential to provide a valuable strategic driver for Ocular’s future pipeline. Through this partnership, Ocular has gained greater confidence in the versatility of its hydrogel platform and its utility in drug delivery routes, which also holds the potential to become an effective method for safely delivering therapeutics to the posterior segment of the eye."

As a VEGF inhibitor, aflibercept inhibits neovascularization and reduces the ability of fluid to pass through blood vessels (vascular permeability) by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. Co-developed by Bayer and Regeneron, it is a blockbuster drug. In 2018, the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for aflibercept injection for the treatment of patients with wet age-related macular degeneration.

It is worth noting that the injectable formulation of aflibercept is expected to face patent expiration challenges in 2025. Currently, its primary competitor in the market is Novartis's Beovu (brolucizumab). Additionally, Amgen is also expected to complete Phase III clinical trials for an aflibercept biosimilar in April 2022.

Source: Ocular Therapeutix™ Announces Termination of the Collaboration with Regeneron to Develop a Sustained-Release Formulation of Aflibercept for the Treatment of Wet AMD and other Serious Retinal Diseases