Ocular Therapeutix Inks Licensing Deal With Regeneron For Wet AMD

Xconomy Boston — 

Ocular Therapeutix announced a deal this morning with Regeneron Pharmaceuticals to develop a sustained-release form of aflibercept (Eylea), Regeneron’s drug for the “wet” form of age-related macular degeneration.

Tarrytown, NY-based Regeneron (NASDAQ: REGN) would pay $10 million to Ocular if it exercises an option to the experimental product. Ocular would be responsible for early stage development of a formulation of aflibercept that can be used with Ocular’s hydrogel-based injection technology, which delivers a drug through an implant in the eye over a period of weeks or months, the companies said in a news release.

Bedford, MA-based Ocular (NASDAQ: OCUL) is responsible for the costs of developing the formulation through Phase 1, and Regeneron will take over development, FDA filing, and commercialization, if it’s approved. In total, Regeneron could pay Ocular as much as $155 million in regulatory and development payments and up to $150 million in commercialization milestone money.

If Regeneron exercises the option, it’ll get more than just rights to an extended-release form of aflibercept, a treatment that inhibits a protein, vascular endothelial growth factor (VEGF), that contributes to the growth of abnormal blood vessels in the eye in patients with wet AMD. Regeneron would also be able to use Ocular’s technology to develop biologic drugs for other eye diseases for which targeting VEGF might be useful.

Ocular, meanwhile, maintains the rights to use its technology with other drugs that don’t target VEGF for retinal diseases, the company said in the press statement.

Ocular makes an implantable device—tiny plugs that are inserted into the tear ducts and designed to release drugs over a prolonged period, which in theory would enable a patient to steer clear of more cumbersome treatments.

The deal is a boost for Ocular, which has had some troubles in clinical trials. Ocular produced mixed results in a study of one of its products, OTX-DP, in patients with eye pain after ophthalmic surgery. OTX-DP also failed the second of two Phase 3 trials in allergic conjunctivitis earlier this year, and had to resubmit a new drug application to the FDA after the agency noted some problems with the manufacturing processes, according to a statement.

For Regeneron, the deal offers a potential new method of progressing aflibercept, one of three drugs for wet AMD that inhibit VEGF.

While Regeneron has enjoyed success with aflibercept—it generated $3.24 billion in sales in 2015—the company has looked to improve on the drug. One method Regeneron attempted was a formulation of aflibercept that also blocked another protein associated with wet AMD, platelet-derived growth factor (PDGF). That treatment, however, failed a Phase 2 trial, according to a statement last month.

A Regneron spokeswoman said in an e-mail that the company is working on ways to improve the product.

Meanwhile, New York-based Ophthotech (Nasdaq: OPHT) has a PDGF blocker it’s hoping will produce better results. The company may soon have data from the first Phase 3 trial of that drug, known as Fovista, which is meant to be injected into the eye after a separate injection with a VEGF blocker.