EyePoint Prescription drugs has commercialized merchandise, however the eye therapies maker desires to give attention to its pipeline, together with a lead program in mid-stage scientific improvement for 2 critical eye problems. To realize this objective, the corporate has struck a deal to promote the remaining rights to one in every of its eye merchandise to a associate for $75 million money, offering an infusion of capital because it appears forward to pivotal exams of its lead drug candidate.
In line with deal phrases introduced Thursday, Alimera Sciences is buying U.S. rights to EyePoint’s Yutiq, a remedy for a sort of eye irritation referred to as uveitis. Alimera already has rights to the product in Europe, the Center East, Canada, Australia, and New Zealand. The deal excludes sure areas in Asia which are lined by separate settlement. Along with the upfront fee, Watertown, Massachusetts-based EyePoint is in line to obtain one other $7.5 million paid in equal quarterly installments subsequent yr.
Yutiq consists of fluocinolone acetonide, a corticosteroid that’s usually used topically to deal with pores and skin circumstances. The EyePoint product, an implant, employs a proprietary drug supply know-how that slowly releases its drug payload over the course of three years. The FDA approval of Yutiq in 2018 covers the therapy of power non-infectious uveitis at the back of the attention. Regardless of profitable regulatory approval, Covid-19 posed challenges for its commercialization. In EyePoint’s 2022 annual report, the corporate stated the pandemic led to a discount in doctor workplace visits. Gross sales for the product in 2022 have been $28.3 million.
EyePoint’s different commercialized product, Dexycu, is a therapy for postoperative irritation after eye surgical procedure. The corporate stopped advertising and marketing the injectable drug this yr, a transfer it attributed to the lack of pass-through reimbursement by the Heart for Medicare and Medicaid Companies at first of 2023.
The drug supply know-how that makes up Yutiq is utilized in EyePoint’s lead pipeline program, EYP-1901. The product candidate administers vorolanib, a tyrosine kinase inhibitor. This program has reached Part 2 improvement for the moist type of age-related macular degeneration and is anticipated to yield preliminary information within the fourth quarter of this yr. A separate Part 2 take a look at of EYP-1901 in non-proliferative diabetic retinopathy is anticipated to finish enrollment within the fourth quarter of this yr. EyePoint plans to begin scientific testing of the drug in diabetic macular edema late this yr or in early 2024.
Within the announcement of the brand new Alimera settlement, EyePoint CEO Nancy Lurker stated the deal allows her firm to repay all excellent financial institution debt and cut back projected overhead bills, extending the money runway into 2025 because it prepares for potential Part 3 exams of EYP-1901.
“This transaction completes EyePoint’s transformation right into a pure play drug improvement firm targeted on advancing and increasing a pipeline of sustained supply therapies for critical eye ailments, together with our lead product candidate EYP-1901, at the moment in Part 2 trials in moist age-related macular degeneration and non-proliferative diabetic retinopathy,” Lurker stated.
For Atlanta-based Alimera, Yutiq enhances Iluvien, the attention product it developed with the EyePoint know-how beneath a 2005 settlement. Within the U.S. and another international locations exterior of Europe, it has approvals to deal with diabetic macular edema. It additionally has approvals in Europe for treating uveitis. Alimera reported the product accounted for $54.1 million in 2022 income. In a ready assertion, Alimera CEO Rick Eiswirth stated putting each merchandise beneath the identical business staff is anticipated to deliver whole income to greater than $100 million in 2024.
Rights to Yutiq in China, Hong Kong, Taiwan, Macau, and Southeast Asia belong to Ocumension Therapeutics beneath a 2018 deal. EyePoint stated that it’s going to nonetheless obtain royalties tied to Ocumension’s progress of the attention product in these Asian markets. Underneath the Alimera deal introduced Thursday, EyePoint will obtain a royalty on Alimera’s U.S. gross sales of Yutiq above sure royalty thresholds for the calendar years 2025 by 2028.
Photograph by Flickr person Rakesh Rocky by way of a Inventive Commons license