EYPT 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• the potential of DURAVYU's multi-mechanism of action to deliver a synergistic anti-inflammatory effect alongside its established VEGF receptor and PDGF receptor inhibition in the treatment of wet AMD and DME;

• our expectations regarding the warning letter we received from the FDA in July 2024, or the Warning Letter, pertaining to YUTIQ® manufacturing, citing alleged violations of cGMP requirements in connection with an FDA inspection at our Watertown facility in February 2024 and our fully executed plan w…

• our ability to comply with our obligations under the Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services;

• DURAVYU brings a potential new multi-mechanism of action paradigm for the treatment of retinal diseases as vorolanib, the active drug in DURAVYU, acts through intracellular inhibition of all VEGF receptors, platelet-derived growth factor (PDGF) receptor, and pro-inflammatory interleukin 6 (IL-6)/JAK…

• DURAVYU is being evaluated in Phase 3 clinical trials for the potential treatment of wet AMD and DME, the two largest retinal disease markets. Enrollment in the pivotal Phase 3 clinical trials for wet AMD is complete with initial data expected in August 2026. The first patients were dosed in both DM…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• our belief that DURAVYU is on track to be the first-to-market of the current investigational sustained release treatments for wet AMD;

• our belief that DURAVYU has two potential blockbuster indications;

• our belief that DURAVYU’s potential real-world application in multiple retinal disease indications and de-risked trial designs position DURAVYU for clinical and commercial success;

• our expectations regarding an agreement in principle with the U.S. Attorneys’ Office for the District of Massachusetts (DOJ) and the Office of the Inspector General of the Department of Health and Human Services related to the DOJ’s investigation into certain of our sales, marketing and promotional …

• our expectations regarding our pending litigation against Ocular Therapeutix, Inc.

相对上期新增的文字 · 来源:10-Q · 2026-08-05

• the duration, scope, and outcome of any governmental inquiries or investigations;

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• the duration, scope, and outcome of any governmental inquiries or investigations, including the ongoing DOJ investigation for which we are seeking a final negotiated resolution;