EyePoint Pharmaceuticals Announces 2022 Clinical Plans and Highlights Recent Corporate and Clinical Achievements
– Updated results from the Phase 1 DAVIO study of EYP-1901 for wet AMD continue to show positive safety and efficacy results out to eight months. Further results to be presented at the February Angiogenesis 2022 virtual meeting –
– Phase 2 study for EYP-1901 in wet AMD expected to initiate in Q3 2022 guided by positive Type C meeting with FDA –
– Announces appointment of
– Record customer demand in Q4 2021 for YUTIQ® and DEXYCU® of approximately 650 and 13,800, units and increases of 16% and 5%, respectively from Q3 2021 –
– DEXYCU alliance with Harrow Health continues EyePoint’s pivot to being a retina-focused company –
– Cash and investments of approximately
“We are extremely proud of our significant progress and growth in 2021, as we successfully initiated, enrolled and reported positive data for our Phase 1 study of EYP-1901 for wet AMD, positioning the program for multiple Phase 2 trials in 2022 after a positive Type C meeting with the FDA in December and bringing us closer to potentially changing the standard of care for patients,” said
2022 Clinical Plans
- Updated eight-month data from the Phase 1 DAVIO study of EYP-1901 for wet AMD has 7 of 17 patients (41%) out to eight months rescue free and continued positive safety profile. Detailed data will be presented on
February 12, 2022at the Angiogenesis 2022 virtual meeting.
- Initiate a randomized, controlled Phase 2 study of EYP-1901 for wet AMD in Q3 2022. The twelve-month wet AMD Phase 2 trial is expected to enroll 144 patients, randomly assigned to one of two doses of EYP-1901 (approximately 2mg or 3mg) or aflibercept control with efficacy endpoints of change in BCVA (best corrected visual acuity), change in CST (central subfield thickness as measured by OCT), time to rescue and safety.
- Initiate a randomized, controlled Phase 2 study of EYP-1901 in diabetic retinopathy (DR) in 2H 2022.
- Continue investment in clinical and R&D organization to support pipeline expansion and growth.
Recent Company Highlights
Research and Development
- Completed a collaborative and positive Type C meeting with the FDA on
December 1, 2021, obtaining specific guidance on both Phase 2 and future pivotal studies for EYP-1901.
- Reported positive interim six-month safety and efficacy data from Phase 1 DAVIO study of EYP-1901 for the potential treatment of wet AMD at the
American Academy of Ophthalmologyannual meeting in November 2021.
- Q4 2021 customer demand of approximately 650 units of YUTIQ and 13,800 units for DEXYCU, compared to approximately 560 units and 13,100 units, respectively for Q3 2021.
$210Min cash and investments at December 31, 2021including over $230 millionin proceeds from two successful follow-on offerings during the year.
U.S.commercial alliance with Harrow Health’s division ImprimisRx, whereby ImprimisRx will assume full responsibility for U.S.sales and marketing activities of DEXYCU and absorb the majority of EyePoint’s DEXYCU commercial organization. EyePoint has retained DEXYCU’s NDA, revenue recognition, manufacturing and distribution responsibilities for all markets. This transaction continues EyePoint’s pivot to being a retina-focused ophthalmology company.
- Strengthened leadership team with the appointment of Dr.
Jay Duker, MD, to Chief Operating Officer in November 2021and Michael C. Pineas Chief Corporate Development and Strategy Officer in January 2022.
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 effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; 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; the success of current and future license agreements; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; manufacturing risks; and other factors described in our filings with the
Source: EyePoint Pharmaceuticals, Inc.