EyePoint Completes Third Safety Review for Duravyu
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 14 2026
0mins
EyePoint announced the independent data safety monitoring committee completed its third scheduled review of the company's pivotal Phase 3 program evaluating Duravyu for wet age-related macular degeneration, recommending both the LUGANO and LUCIA trials continue as planned with no protocol modifications. Interim masked safety data show a continued favorable safety profile, consistent with safety observed in over 190 patients across four completed clinical trials. As of May 2, all active patients in the treatment arm have reached the Week 32 visit, receiving their second DURAVYU dose, with over 35% also receiving a third planned dose at Week 56. LUGANO topline data is on track for mid-2026, with LUCIA to follow shortly after; this is the last anticipated committee review ahead of topline data. "Safety is paramount in retinal disease therapies, and receiving three consecutive positive DSMC recommendations to continue our Phase 3 wet AMD trials without modification reflects the consistency of DURAVYU's safety profile and the rigor of our Phase 3 wet AMD program design," said Ramiro Ribeiro, chief medical officer.
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Analyst Views on EYPT
Wall Street analysts forecast EYPT stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 13.500
Low
20.00
Averages
31.50
High
43.00
Current: 13.500
Low
20.00
Averages
31.50
High
43.00
About EYPT
EyePoint, Inc., formerly EyePoint Pharmaceuticals, Inc., is a clinical-stage biopharmaceutical company. The Company is focused on developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases. The Company’s lead product candidate, DURAVYU, is an investigational-sustained delivery treatment for serious retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor, with bioerodible Durasert E technology. Vorolanib features a novel multi-mechanism of action as it targets both vascular endothelial growth factor (VEGF)-mediated vascular permeability and IL-6 mediated inflammation through inhibition of all VEGF receptors and pro-inflammatory IL-6/JAK1 signaling. DURAVYU is in Phase III pivotal trials for wet age-related macular degeneration. DURAVYU is also being advanced for the treatment of diabetic macular edema (DME) with the first patient dosing in Phase III trials.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Product Development Progress: EyePoint's lead product, DURAVYU™, is currently undergoing Phase 3 pivotal trials for wet age-related macular degeneration and diabetic macular edema, with topline data expected in mid-2026 for wet AMD, which could significantly enhance the company's market position if successful.
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- Technological Innovation: DURAVYU™ combines the selective tyrosine kinase inhibitor vorolanib with next-generation bioerodible Durasert E™ technology to provide sustained therapeutic effects, aiming to improve patient quality of life and demonstrating EyePoint's innovative capabilities in retinal disease treatment.
- Market Positioning and Strategy: EyePoint is committed to partnering with the retina community to enhance patient lives while creating long-term value, having approved four drugs over three decades and treated tens of thousands of eyes, showcasing its leadership and influence in the industry.
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- Exercise Price Set: The options have an exercise price of $12.35 per share, which is the closing price of EyePoint's stock on the grant date, ensuring that potential employee gains are closely tied to the company's performance over the next four years.
- Vesting Arrangement: The options vest over four years, with 25% vesting on the first anniversary and the remainder vesting monthly, a structure that not only incentivizes long-term employee retention but also enhances overall operational efficiency for the company.
- R&D Progress: EyePoint is conducting Phase 3 clinical trials for DURAVYU™, targeting serious retinal diseases, with topline data for wet age-related macular degeneration (wet AMD) expected in mid-2026, which could significantly enhance the company's market competitiveness.
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- Clinical Trial Advancements: EyePoint is seeing strong momentum in its DME program, with expectations to achieve full enrollment in both pivotal trials by Q3 2026, and over one-third of patients already enrolled, reflecting effective utilization of its clinical trial infrastructure and investigator network.
See More
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- Performance Track Record: Over the past year, EyePoint has beaten EPS estimates 50% of the time and has exceeded revenue estimates 100% of the time, suggesting a degree of stability in revenue management despite broader challenges.
- Revision Trends: In the last three months, there have been no upward revisions to EPS estimates and four downward revisions, while revenue estimates also saw no upward revisions with one downward adjustment, reflecting analysts' cautious outlook on the company's future performance.
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- Earnings Report Expectations: The upcoming quarterly report is expected to show a loss of $0.94 per share, representing a year-over-year decline of 182.5%, with revenues projected at $17.09 million, down 91% from the previous year, highlighting significant financial challenges ahead for the company.
- Earnings Estimate Revisions: Over the last 30 days, the consensus EPS estimate for Arvinas has been revised 1.3% lower, and negative trends in earnings estimate revisions typically do not bode well for stock price appreciation, prompting investors to monitor ARVN's future performance closely.
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