EyePoint Pharmaceuticals Inc. (EYPT:NASDAQ) completed patient enrollment for its Phase 2 DAVIO 2 trial evaluating its lead drug candidate EYP-1901 in wet age-related macular degeneration (AMD), reported H.C. Wainwright & Co. analyst Dr. Yi Chen in a March 27 research note. Topline six-month results from DAVIO 2 are expected in Q4/23.
Target Implies 996% Gain
This U.S. company, developing treatments for serious eye disorders, is a Buy, noted Chen.
Further, it offers investors a significant potential return of 996%, evidenced by the large gap between EyePoint's current share price of US$3.24 and H.C. Wainwright's price target on the pharma of US$25 per share.
About the Trial
In DAVIO 2, EYP-1901 is being evaluated as a single-dose, six-month therapy for patients with wet AMD. This drug, which is vorolanib in a bioerodible Durasert, is administered intravitreally.
"Positive results from DAVIO 2 would allow this 'treat to maintain' therapeutic approach to proceed to a pivotal Phase 3 trial in 2024, in our view," Chen wrote.
The design of DAVIO 2 called for 144 participants, but total enrollment came to 160 "due to strong investigator and patient interest," noted Chen. All enrollees previously received standard-of-care anti-VEGF, or anti–vascular endothelial growth factor therapy, for wet AMD.
In EyePoint's study, patients, on a randomized basis, will receive one of two doses of EYP-1901, about 2 or 3 milligrams, or an on-label aflibercept control.
The primary efficacy endpoint is noninferiority to the aflibercept control. This will be quantified by the change in best-corrected visual acuity six months after treatment.
Secondary efficacy endpoints include a change in central subfield thickness as measured by optical coherence tomography, the number of eyes still not needing supplemental anti-VEGF injections, the number of aflibercept injections administered in each group, and safety.
Second Study Advancing
In other news, Chen reported that enrollment in EyePoint's Phase 2 PAVIA trial is progressing such that it should be done in Q4/23. PAVIA is another study evaluating the pharma's EYP-1901 but as a single-dose, nine-month treatment for nonproliferative diabetic retinopathy (NPDR). The enrollment target for PAVIA is 105 patients with moderately severe to severe NPDR.
"Given that NPDR patients usually do not get treated until they develop sight-threatening complications, we believe a long-acting anti-VEGF treatment such as EYP-1901 could proactively help maintain patients' existing vision and increase the number of patients treated," wrote Chen.
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Disclosures for H.C. Wainwright & Co., EyePoint Pharmaceuticals Inc., March 27, 2023
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.
I, Yi Chen, Ph.D. CFA and Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of EyePoint Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of February 28, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of EyePoint Pharmaceuticals, Inc.
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. Mr. Selvaraju, who is [the][an] author of this report, is the Chairman of and receives compensation from Relief Therapeutics Holding SA, a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis ("Relief"). You should consider Mr. Selvaraju's position with Relief when reading this research report.
The firm or its affiliates received compensation from EyePoint Pharmaceuticals, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did receive compensation from EyePoint Pharmaceuticals, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
The Firm does not make a market in EyePoint Pharmaceuticals, Inc. as of the date of this research report.
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