Ocular Therapeutix (NSDQ:OCUL) said today that it landed a licensing deal with Regeneron (NSDQ:REGN) to develop a sustained-release version of Regeneron’s aflibercept (Eylea), a therapy for wet age-related macular degeneration.
The deal will cost Regeneron $10 million up front, and in total could cost the Tarrytown, N.Y.-based biotech $315 million if regulatory and commercialization milestones are met.
The terms of the agreement make Ocular responsible for early-stage development of a sustained release version of aflibercept formula that can be used with the Bedford, Mass.-based company’s hydrogel technology.
Regeneron’s aflibercept inhibits vascular endothelial growth factor (VEGF), a protein that contributes to the development of abnormal blood vessels in the eyes of patients with wet AMD. According to the deal with Ocular, Regeneron will get the rights to an extended-release version of aflivercept and be able to use Ocular’s delivery tech to develop drugs for other eyes diseases that involve targeting VEGF.
Ocular will maintain the rights to its tech for applications that don’t involve targeting VEGF. The company also provided an update on its development strategy for the sustained release intravitreal depot technology for the treatment of serious retinal diseases.
“In preclinical studies completed to date, we have demonstrated up to 6 months of sustained release of anti-VEGF drugs using our hydrogel-based drug delivery technology with a good safety profile,” Ocular chief medical officer Dr. Jon Talamo said in prepared remarks. “A 4-6-month sustained release formulation has the potential to advance the current standard of care in wet AMD and other retinal diseases by significantly reducing injection frequency. We have also demonstrated minimal inflammatory response in vivo through 26 weeks with both our anti-VEGF protein and TKI depots currently in development. This technology represents an exciting development in the field of ophthalmology and we look forward to further advancing these programs.”
“We have made considerable progress in developing our protein drug delivery platform at Ocular Therapeutix, so it is good to see an industry leader such as Regeneron recognizing the potential of this technology,” Ocular Therapeutix president & CEO Amar Sawhney said in prepared remarks. “We are excited to partner with Regeneron to develop a potential 1st-in-class sustained release protein-based anti-VEGF hydrogel injection for wet AMD, DME, RVO, and other serious retinal diseases. This sustained release formulation could have the potential to significantly reduce dosing frequency and subsequently reduce doctor visits, thus reducing the burden of care for patients, caregivers and physicians, and may decrease the likelihood of certain side effects associated with frequent intravitreal injections.”
The deal with Regeneron is a boost for Ocular, since its experimental drug treating postoperative ocular pain , Dextenza, was denied approval by the FDA. In June, the company saw shares drop over 40% after reporting the 2nd Phase III clinical trial of Dextenza failed to meet its primary endpoint.