EyePoint Pharmaceuticals Announces 2022 Clinical Plans and Highlights Recent Corporate and Clinical Achievements

EyePoint Pharmaceuticals announced its 2022 clinical pipeline plans and highlighted recent corporate achievements driven by its lead pipeline candidate, EYP-1901, a potential 6-month intravitreal treatment targeting wet age-related macular degeneration (AMD).

“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,” Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals, said in a company news release. “We also significantly improved our balance sheet and ended 2021 with approximately $210 million in cash and investments, providing us with a strong foundation as we work to expand our pipeline with additional programs.”

Ms. Lurker continued, “As we look ahead to 2022, EyePoint is focused on pipeline growth and expansion, with the ultimate goal of improving the lives of patients with serious eye disorders and bringing innovative products to patients in the United States and around the world. We look forward to continued advancement of our programs through clinical development, while also positioning our commercial franchises, DEXYCU® and YUTIQ®, to breakeven in 2022.”

2022 Clinical Plans

• Updated 8-month data from the phase 1 DAVIO study of EYP-1901 for wet AMD has 7 of 17 patients (41%) out to 8 months rescue free and continued positive safety profile. Detailed data will be presented on February 12, 2022 at the Angiogenesis 2022 virtual meeting.
• Initiate a randomized, controlled phase 2 study of EYP-1901 for wet AMD in Q3 2022. The 12-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 Ophthalmology annual meeting in November 2021.

Corporate

• 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.
• Approximately $210M in cash and investments at December 31, 2021 including over $230 million in proceeds from two successful follow-on offerings during the year.
• Expanded 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 2021 and Michael C. Pine as Chief Corporate Development and Strategy Officer in January 2022.