EyePoint Pharmaceuticals Investor Day to Highlight EYP-1901 and Durasert® Technology Developments and Provide a Financial Update
- Positive 12-Month Safety and Efficacy Data from Phase 1 DAVIO Clinical Trial Evaluating EYP-1901 for the Treatment of Wet
- Phase 2 clinical trial (DAVIO 2) in wet
- Net product revenue of
- CMS Draft Hospital Outpatient Rule does not extend pass-through status of expiring drugs which will impact reimbursement for DEXYCU® after
- Investor Day live webcast today,
“EyePoint is helping to change the treatment paradigm of wet
Investor Day will feature commentary from EyePoint’s management team as well as key opinion leader guest speakers, Carl
Investor Day Highlights:
Nancy Lurker, Chief Executive Officer will present an overview of the Company. Jay Duker M.D., Chief Operating Officer will present an overview of EYP-1901 using a bioerodible formulation of EyePoint’s proprietary Durasert® technology for sustained intraocular drug delivery, which has been safely administered to over 80,000 patients’ eyes across four U.S.FDA approved products.
- Said Saim, Ph.D., Chief Technology Officer, will present an overview of EYP-1901 preclinical data, including its development and formulation and new pre-clinical data highlighting neuroprotection potential for EYP-1901.
Carl Regillo, M.D., FACS, Professor of Ophthalmology, Thomas Jefferson University, will present the 12-month safety and efficacy data from the Phase 1 DAVIO clinical trial evaluating EYP-1901 for the potential treatment of wet AMDthat showed continued positive safety and efficacy for EYP-1901 including no serious ocular adverse events and 35% of patients out to 12 months with no supplemental anti-VEGF treatment after the initial EYP-1901 insert was administered. Charles Wykoff, M.D., Ph.D., Director of Research, Retina Consultants of Texas, and Jay Duker M.D., Chief Operating Officer, will discuss the potential opportunity of EYP-1901 as a “treat to maintain” maintenance therapy for wet AMD.
- Dario Paggiarino, M.D., Chief Medical Officer will present the EYP-1901 Phase 2 plans in wet
AMDand NPDR with first patient dosing anticipated in Q3 2022. He will also provide an update on two ongoing Phase 4 studies for YUTIQ®, (fluocinolone acetonide intravitreal implant) 0.18 mg, for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye. George Elston, Chief Financial Officer, will provide a financial update on Q2 2022 performance with net product revenue of $11.3 millionfor the quarter and cash and investments of $171 millionat June 30, 2022. He will also discuss the potential impact of the 2023 CMS Draft HOPPS (Hospital Outpatient) rule released last week in which CMS has indicated its intention not to provide further pass-through extension to expiring products, including DEXYCU. If the draft rule becomes final, DEXYCU will lose pass-through separate reimbursement status on December 31, 2022and will instead be bundled into the general Cataract procedure reimbursement code starting on January 1, 2023.
The preliminary second quarter 2022 revenue results and cash and investments on hand included in this release were calculated prior to the completion of a review by the Company’s independent registered public accounting firm and are therefore subject to adjustment.
Investor Day Webcast Information
A webcast and subsequent archived replay of the presentation may be accessed via the Investors section of the Company website at www.eyepointpharma.com. The replay will be available for 90 days after the event.
EYP-1901 is being developed as an investigational sustained delivery treatment, initially in wet age-related macular degeneration (wet AMD) combining a bioerodible formulation of EyePoint's proprietary Durasert® delivery technology with vorolanib, a tyrosine kinase inhibitor. Positive twelve-month safety and efficacy data from the Phase 1 DAVIO clinical trial of EYP-1901 showed no reports of ocular or drug-related systemic serious adverse events and no dose limiting toxicities with stable visual acuity and OCT. Further, 53% of eyes did not require supplemental anti-VEGF injections up to six months following a single dose of EYP-1901. Phase 2 clinical trials for wet AMD (DAVIO 2) and non-proliferative diabetic retinopathy are expected to begin dosing patients in Q3 2022. A Phase 2 clinical trial is planned for diabetic macular edema in 2023. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.
Forward Looking Statements
EYEPOINT PHARMACEUTICALS SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a sustained delivery intravitreal anti-VEGF treatment for serious eye diseases, including wet age-related macular degeneration; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of our commercialized products, YUTIQ® and DEXYCU®; market acceptance of our products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; the continued impact of the COVID-19 pandemic on EyePoint’s business, the medical community and the global economy; and the impact of general business and economic conditions. More detailed information on these and additional factors that could affect EyePoint’s actual results are described in EyePoint’s filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended
Source: EyePoint Pharmaceuticals, Inc.