Sunday, June 4, 2023

EyePoint Pharma Sells U.S. Rights to Eye Med to Become Pure Play Drug Developer – MedCity News

EyePoint Pharmaceuticals has commercialized products, but the eye therapies maker wants to focus on its pipeline, including a lead program in mid-stage clinical development for two serious eye disorders. To achieve this goal, the company has struck a deal to sell the remaining rights to one of its eye products to a partner for $75 million cash, providing an infusion of capital as it looks ahead to pivotal tests of its lead drug candidate.

According to deal terms announced Thursday, Alimera Sciences is acquiring U.S. rights to EyePoint’s Yutiq, a therapy for a type of eye inflammation called uveitis. Alimera already has rights to the product in Europe, the Middle East, Canada, Australia, and New Zealand.  The deal excludes certain regions in Asia that are covered by separate agreement. In addition to the upfront payment, Watertown, Massachusetts-based EyePoint is in line to receive another $7.5 million paid in equal quarterly installments next year.

Yutiq includes fluocinolone acetonide, a corticosteroid that is typically used topically to treat skin conditions. The EyePoint product, an implant, employs a proprietary drug delivery technology that slowly releases its drug payload over the course of three years. The FDA approval of Yutiq in 2018 covers the treatment of chronic non-infectious uveitis in the back of the eye. Despite winning regulatory approval, Covid-19 posed challenges for its commercialization. In EyePoint’s 2022 annual report, the company said the pandemic led to a reduction in physician office visits. Sales for the product in 2022 were $28.3 million.

EyePoint’s other commercialized product, Dexycu, is a treatment for postoperative inflammation after eye surgery. The company stopped marketing the injectable drug this year, a move it attributed to the loss of pass-through reimbursement by the Center for Medicare and Medicaid Services at the start of 2023.

The drug delivery technology that makes up Yutiq is used in EyePoint’s lead pipeline program, EYP-1901. The product candidate administers vorolanib, a tyrosine kinase inhibitor. This program has reached Phase 2 development for the wet form of age-related macular degeneration and is expected to yield preliminary data in the fourth quarter of this year. A separate Phase 2 test of EYP-1901 in non-proliferative diabetic retinopathy is expected to complete enrollment in the fourth quarter of this year. EyePoint plans to start clinical testing of the drug in diabetic macular edema late this year or in early 2024.

In the announcement of the new Alimera agreement, EyePoint CEO Nancy Lurker said the deal enables her company to pay off all outstanding bank debt and reduce projected overhead expenses, extending the cash runway into 2025 as it prepares for potential Phase 3 tests of EYP-1901.

“This transaction completes EyePoint’s transformation into a pure play drug development company focused on advancing and expanding a pipeline of sustained delivery treatments for serious eye diseases, including our lead product candidate EYP-1901, currently in Phase 2 trials in wet age-related macular degeneration and non-proliferative diabetic retinopathy,” Lurker said.

For Atlanta-based Alimera, Yutiq complements Iluvien, the eye product it developed with the EyePoint technology under a 2005 agreement. In the U.S. and some other countries outside of Europe, it has approvals to treat diabetic macular edema. It also has approvals in Europe for treating uveitis. Alimera reported the product accounted for $54.1 million in 2022 revenue. In a prepared statement, Alimera CEO Rick Eiswirth said placing both products under the same commercial team is expected to bring total revenue to more than $100 million in 2024.

Rights to Yutiq in China, Hong Kong, Taiwan, Macau, and Southeast Asia belong to Ocumension Therapeutics under a 2018 deal. EyePoint said that it will still receive royalties tied to Ocumension’s progress of the eye product in those Asian markets. Under the Alimera deal announced Thursday, EyePoint will receive a royalty on Alimera’s U.S. sales of Yutiq above certain royalty thresholds for the calendar years 2025 through 2028.

Photo by Flickr user Rakesh Rocky via a Creative Commons license

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