In a deal that could be worth more than $300 million, Ocular Therapeutix announced that it has entered into a strategic collaboration, option, and license agreement with Regeneron Pharmaceuticals to collaborate on the development of a sustained-release formulation of the vascular endothelial growth factor (VEGF) trap aflibercept for the treatment of wet age-related macular degeneration (AMD) and other serious retinal diseases. This formulation is currently in preclinical development. Regeneron’s aflibercept is currently approved by the FDA for certain indications under the brand name Eylea.
Ocular Therapeutix is currently developing proprietary sustained-release hydrogel-based drug delivery depots for intravitreal injection that can be formulated with both small and large molecule pharmaceuticals, such as tyrosine kinase inhibitors (TKIs) and protein-based anti-VEGFs, respectively, with the goal of delivering sustained and therapeutic levels of drugs to targeted ocular tissues.
"We have teamed up (with Regeneron) to try to develop an extended-release version of Eylea. Eylea is given every month or 2 months depending on the treatment paradigm, and we hope to be able to reduce those numbers of injections by developing an injection that will be given only once in 4 to 6 months," Amar Sawhney, PhD, President, Chief Executive Officer and Chairman of Ocular Therapeutix, said in an interview with EyewireTV at the Ophthalmology Innovation Summit minutes after the deal was announced. "We bring our hydrogel technology to the mix and provide a drug depot that can be injected though fine-gauge needles to be able to create a depot that could elude that drug out over a 4 to 6 month period, and potentially reduce those numbers of injections.”
"There’s a lot of work ahead and there’s a lot of good science to be done, but we cannot think of a better partner and a better science-driven company who we have good chemistry with to make the journey. So we are very excited about that," Dr. Sawhney added.
Under the terms of the agreement, Ocular Therapeutix and Regeneron will aim to develop a sustained-release formulation of aflibercept that is suitable for advancement into clinical development. Regeneron has the option to obtain an exclusive license to use Ocular Therapeutix’s hydrogel-based technology for the development and commercialization of a sustained-release formulation of aflibercept and other biologics targeting VEGF for ophthalmic indications. Ocular Therapeutix will retain all rights to develop its sustained-release hydrogel-based drug delivery platform with all other non-VEGF targeting compounds as well as with small molecule pharmaceuticals, including TKIs, for other retinal diseases.
Upon exercising of the option, Ocular Therapeutix would receive a payment of $10 million from Regeneron and Ocular Therapeutix would be responsible for funding development through phase 1. Regeneron would be responsible for any subsequent development and commercialization costs. Ocular Therapeutix would be eligible to receive up to $305 million in milestone payments from Regeneron for a sustained-release version of aflibercept containing Ocular Therapeutix’s sustained-release hydrogel depot, comprised of up to $155 million in development and regulatory milestone payments, $100 million for the first commercial sale, and up to $50 million in commercial milestone payments. In addition, Ocular Therapeutix is eligible to receive tiered high single-digit to low-to-mid teen-digit royalties on potential future net sales.