Latest news with #wetAMD
Yahoo
06-08-2025
- Business
- Yahoo
EyePoint Reports Second Quarter 2025 Financial Results and Highlights Recent Corporate Developments
– Completed Phase 3 enrollment for DURAVYU™ in wet AMD with over 800 patients enrolled and randomized – – LUGANO and LUCIA trials each rapidly enrolled in seven months underscoring strong physician and patient interest – – Topline 56-week data for LUGANO on track for readout in mid-2026 with LUCIA topline data to closely follow – – Northbridge, MA commercial manufacturing facility on line with DURAVYU registration batches underway – – $256 million of cash, cash equivalents and marketable securities as of June 30, 2025, provides cash runway into 2027, beyond topline data for both Phase 3 wet AMD trials – WATERTOWN, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the second quarter ended June 30, 2025, and highlighted recent corporate developments. 'In recent months, we continued our track record of exceptional execution across all aspects of the business, most notably completing enrollment in both pivotal Phase 3 trials, LUGANO and LUCIA, in wet AMD in record time for this indication,' said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. 'The noteworthy physician and patient enthusiasm we have seen for our Phase 3 program across U.S. and international sites—supported by DURAVYU's robust Phase 2 efficacy and safety data package and our patient-centric, well-understood trial design—has reinforced the clear need and global demand for more durable wet AMD therapies and the role that DURAVYU can play in meaningfully extending the wet AMD treatment paradigm.' Dr. Duker continued, 'With topline LUGANO data anticipated in mid-2026, LUCIA data to closely follow, and registration batches underway at our state-of-the-art, commercial manufacturing facility in Northbridge, Massachusetts, we believe we are well-positioned for DURAVYU to be first-to-market among investigational sustained release treatments for wet AMD. We look forward to providing an update on our DURAVYU pivotal plan in DME in the coming months as we work to deliver innovative therapeutics for multiple serious retinal diseases.' R&D Highlights and Updates Completed enrollment of Phase 3 wet AMD pivotal program ahead of plan. LUGANO and LUCIA are double-masked non-inferiority trials designed to support a clear approval pathway and potential commercial success. Both Phase 3 trials experienced unprecedented enrollment exceeding observed recruitment rates of comparable historical and ongoing wet AMD clinical trials The oversubscribed LUGANO trial randomized 432 patients in the U.S. in seven months with topline data anticipated in mid-2026. LUCIA randomized over 400 patients in the U.S. and in ex-U.S. sites over a seven-month period, with topline data anticipated in the second half of 2026. Enrolled the first ex-U.S. patient in the LUCIA trial in Israel with patient participation in sites throughout the Czech Republic, South America, Europe, Australia and India. Investigator and patient enthusiasm for the trials underscores the retinal community's support and recognition of the clinical rigor underpinning the Phase 3 pivotal program. Announced that based on interim masked safety data, the safety profile observed in LUGANO and LUCIA is consistent with previous DURAVYU clinical trials. In parallel, an independent Data Safety Monitoring Committee ('DSMC') convened and recommended continuation of the program as planned. Received approval of the Phase 3 protocols for the LUGANO and LUCIA trials by the European Medicines Agency (EMA). Delivered multiple oral presentations at the American Society of Retina Specialists (ASRS) annual meeting supporting DURAVYU's potentially best-in-class therapeutic profile as a sustained release tyrosine kinase inhibitor (TKI) being developed for multiple indications: An assessment of the treatment burden in wet AMD treated with DURAVYU versus aflibercept from the Phase 2 DAVIO 2 clinical trial Vision outcomes from the DAVIO 2 trial for the treatment of neovascular age-related macular degeneration 24-week results from the Phase 2 VERONA clinical trial of DURAVYU versus aflibercept for the treatment of diabetic macular edema (DME) Completed a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss pivotal Phase 3 clinical trial plans for DURAVYU in DME. The Company will share details on its DME pivotal plan in the second half of 2025. Presented 24-week topline results from the Phase 2 VERONA study in DME at the Retina World Congress in May 2025, highlighting DURAVYU's potential to transform the treatment landscape in DME, the second largest retinal disease market, with its best-in-class safety and efficacy profile. Accepted to present the Phase 2 VERONA 24-week end-of-study results in DME at the Retina Society Annual Meeting in September, underscoring the broad treatment potential of DURAVYU and enthusiasm from the retinal community for new treatment options in multiple serious retinal diseases. Recent Corporate Highlights Initiated DURAVYU registration batches in support of a potential NDA filing at EyePoint's commercial manufacturing facility in Northbridge, Massachusetts. The 41,000-square-foot facility was built to meet both FDA and EMA standards and will have capacity to support the anticipated significant demand for DURAVYU, if approved. Review of Results for the Second Quarter Ended June 30, 2025 For the second quarter ended June 30, 2025, total net revenue was $5.3 million compared to $9.5 million for the quarter ended June 30, 2024. Net revenue from license and royalties for the second quarter ended June 30, 2025, totaled $5.3 million compared to $8.4 million in the corresponding period in 2024. The decrease was primarily driven by lower recognition of deferred revenue related to the Company's 2023 agreement for the license of YUTIQ® product rights. Operating expenses for the second quarter ended June 30, 2025, totaled $67.6 million versus $44.0 million in the prior year period. This increase was primarily driven by an increase in clinical trial costs related to ongoing DURAVYU™ Phase 3 clinical trials (LUGANO and LUCIA) for wet AMD. Net non-operating income totaled $2.9 million and net loss was $59.4 million, or ($0.85) per share, compared to a net loss of $30.8 million, or ($0.58) per share, for the corresponding period in 2024. Cash, cash equivalents, and marketable securities as of June 30, 2025 totaled $256 million compared to $371 million as of December 31, 2024. Financial Outlook EyePoint expects its cash, cash equivalents, and marketable securities as of June 30, 2025 will enable the Company to fund operations into 2027 beyond topline Phase 3 data for DURAVYU in wet AMD expected in 2026. Conference Call Information EyePoint management will host a conference call today at 8:30 a.m. ET to discuss the results for the second quarter ended June 30, 2025, and recent corporate developments. To access the live conference call, please register using the audio conference link: A live audio webcast of the event can be accessed via the Investors section of the Company website at A webcast replay will also be available on the corporate website at the conclusion of the call. About EyePoint EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. The Company's lead product candidate, DURAVYU™, is an innovative investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI), in next-generation bioerodible Durasert E™ technology. Supported by robust safety and efficacy data to date, DURAVYU is currently being evaluated in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) with topline data anticipated in 2026. DURAVYU also completed a positive Phase 2 clinical trial in diabetic macular edema (DME) with Phase 3 pivotal planning underway. Despite current therapies, patients with wet AMD and DME still tend to lose vision in the long term and wet AMD is the leading cause of vision loss among people 50 years of age and older in the United States. The Company is committed to partnering with the retina community to improve patient lives while creating long-term value, with four approved drugs over three decades and tens of thousands of eyes treated with EyePoint innovation. EyePoint is headquartered in Watertown, Massachusetts, with a commercial manufacturing facility in Northbridge, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product candidate; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. Forward Looking Statements EYEPOINT 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 our expectations regarding our clinical development and regulatory plans of DURAVYU; our belief that DURAVYU is on track to be the first-to-market of the current investigational sustained release treatments for wet AMD; our belief that DURAVYU has two potential blockbuster indications; our belief that DURAVYU's potential real-world application in multiple retinal disease indications and de-risked trial designs position DURAVYU for clinical and commercial success; our expectations regarding timing for the completion of clinical trial enrollment and the timing of the availability and release of clinical data; our belief that rapid trial enrollment in LUGANO and LUCIA highlights physician and patient enthusiasm for DURAVYU, which we believe is driven by an established and familiar trial design, robust Phase 2 data, and a strong safety profile; our expectations regarding cash runway; our optimism that that DURAVYU has the potential to shift the treatment paradigm in wet AMD and DME and improve patient outcomes; our expectations regarding clinical development of our other product candidates, including EYP-2301; our belief that we are well positioned as the leader in ocular sustained drug delivery; our business strategies and objectives; and other statements regarding the Company's future plans, objectives, strategies and beliefs, as identified by words such as 'will,' 'potential,' 'could,' 'can,' 'believe,' 'intends,' 'continue,' 'plans,' 'expects,' 'anticipates,' 'estimates,' 'may,' or 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, these risks and uncertainties include the timing, progress and results of the Company's clinical development activities, including DURAVYU; uncertainties and delays relating to communications with the U.S. Food and Drug Administration and the ability to obtain regulatory approval from FDA for the commercialization of DURAVYU; unanticipated costs and expenses; the Company's cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the Company's product candidates; changes in the regulatory environment; disruptions at the FDA, including due to a reduction in the FDA's workforce and/or inadequate funding for the FDA; changes in U.S. and international trade policies; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; the Company's ability to obtain additional funding to support its clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney's Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to the Company's Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. A more complete discussion of the risks and uncertainties that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in our most recent Annual Report on Form 10-K, in our other filings with the Securities and Exchange Commission (SEC) and in our future reports to be filed with the SEC, which are available at Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors: Tanner Kaufman / Jenni LuFTI Consulting Direct: 203-722-8743 / / Media Contact: Amy PhillipsGreen Room CommunicationsDirect: 412-327-9499aphillips@ PHARMACEUTICALS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (In thousands) June 30, December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 71,143 $ 99,704 Marketable securities 184,590 271,209 Accounts and other receivables, net 625 607 Prepaid expenses and other current assets 6,215 9,481 Inventory 2,678 2,305 Total current assets 265,251 383,306 Operating lease right-of-use assets 21,089 21,000 Other assets 14,807 14,159 Total assets $ 301,147 $ 418,465 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses $ 31,163 $ 29,824 Deferred revenue — 17,784 Other current liabilities 2,012 1,440 Total current liabilities 33,175 49,048 Deferred revenue - noncurrent — 10,853 Operating lease liabilities - noncurrent 21,815 21,858 Other noncurrent liabilities 148 205 Total liabilities 55,138 81,964 Stockholders' equity: Capital 1,222,814 1,208,489 Accumulated deficit (977,637 ) (873,016 ) Accumulated other comprehensive income 832 1,028 Total stockholders' equity 246,009 336,501 Total liabilities and stockholders' equity $ 301,147 $ 418,465 EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 Revenues: Product sales, net $ — $ 1,068 $ 715 $ 1,726 License and collaboration agreements 5,333 7,782 16,382 18,345 Royalty income — 627 12,689 1,090 Total revenues 5,333 9,477 29,786 21,161 Operating expenses: Cost of sales 165 1,401 970 2,160 Research and development 55,498 29,822 114,072 60,011 Sales and marketing 35 50 70 56 General and administrative 11,862 12,750 25,738 26,801 Total operating expenses 67,560 44,023 140,850 89,028 Loss from operations (62,227 ) (34,546 ) (111,064 ) (67,867 ) Other income (expense): Interest and other income, net 2,894 3,720 6,536 7,757 Total other income, net 2,894 3,720 6,536 7,757 Net loss before provision for income taxes $ (59,333 ) $ (30,826 ) $ (104,528 ) $ (60,110 ) Provision for income taxes (93 ) — (93 ) — Net loss $ (59,426 ) $ (30,826 ) $ (104,621 ) $ (60,110 ) Net loss per common share - basic and diluted $ (0.85 ) $ (0.58 ) $ (1.50 ) $ (1.13 ) Weighted average common shares outstanding - basic and diluted 69,926 53,206 69,847 53,059 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Health Line
07-06-2025
- Health
- Health Line
GLP-1 Drugs Linked to Age-Related Macular Degeneration, Study Finds
GLP-1 drugs are associated with a higher risk of 'wet' age-related macular degeneration in people with type 2 diabetes, according to a new study. Researchers found that the risk substantially increased the longer people were prescribed a GLP-1 drug, particularly those containing semaglutide. GLP-1 medications like Ozempic and Wegovy have surged in popularity as weight loss treatments, but ophthalmologists say their potential risks to eye health are not well understood. GLP-1 drugs are linked to a significantly higher risk of developing neovascular or 'wet' age-related macular degeneration, according to new research. The study, conducted by researchers at the University of Toronto, found that people with type 2 diabetes who were prescribed GLP-1s were more than twice as likely to develop wet AMD as those who weren't. The study also found that the longer subjects were treated with these medications, the greater their risk of developing wet AMD. Neovascular age-related macular degeneration, commonly known as wet AMD, is the less common but more aggressive form of age-related macular degeneration, and a leading cause of irreversible vision loss among older adults in the United States. The findings, published on June 5 in JAMA Ophthalmology, suggest that doctors and patients should be aware of the potential risks, even though the chance of developing the condition remains relatively low. GLP-1 drugs, a class of blockbuster diabetes and obesity drugs sold under brand names like Ozempic and Wegovy, have surged in popularity in recent years. They offer a range of substantial benefits, including weight loss, improved blood sugar levels, and reduced cardiovascular disease risk. Despite these benefits, ophthalmologists say the impact of GLP-1 drugs on eye health is not well understood. Studies have identified an association between the medications and other eye conditions, including diabetic retinopathy and non-arteritic anterior ischemic optic neuropathy (NAION). While the findings don't establish a clear causal link between GLP-1 drugs and eye disease, experts say there's still reason for caution. 'The dose-response effect we observed — where longer GLP-1 receptor agonist exposure was associated with higher risk — strengthens the argument that this association may reflect a true biological effect rather than being due to confounding factors,' said study co-author Andrew Mihalache, MD(C), of the Temerty Faculty of Medicine at the University of Toronto, Canada. 'Seeing a graded relationship like this suggests that prolonged exposure could play a causal role in increasing risk. However, this needs to be confirmed in future studies,' he told Healthline. Long-term GLP-1 drug use may triple wet AMD risk Drawing on health records from Ontario, Canada, researchers at the University of Toronto analyzed nearly 140,000 adults with type 2 diabetes to investigate a possible link between GLP-1 use and wet AMD. The retrospective study tracked patient outcomes over a three-year period, using data collected between 2020 and 2023. Roughly one-third of participants — about 46,000 people — had been prescribed a GLP-1 drug for at least six months. The rest had not. In the vast majority of cases (97.5%), that drug was semaglutide, the active ingredient in Ozempic and Wegovy. The average participant was 66, and the cohort was almost evenly divided by sex, with females representing 46.6% of the group. On average, those who were prescribed a GLP-1 drug were more than twice as likely to be diagnosed with wet AMD. However, that number doesn't tell the full story. People who took GLP-1 drugs for longer experienced progressively greater risk. Those who had only taken their medication for 6–18 months actually had a slightly lower risk than those who didn't take the medication. However, at the 18–30 month mark, GLP-1 users' risk of developing wet AMD more than doubled compared to non-users. And those taking the drugs for 30 months or longer had more than triple the risk. 'This was definitely surprising, especially given the growing enthusiasm for GLP-1 receptor agonists for their cardiovascular and metabolic benefits. It really highlights the need for further investigation into their ocular safety profile,' first study author Reut Shor, MD, of the Department of Ophthalmology and Vision Sciences at the University of Toronto, Canada, told Healthline. Despite the increase in risk, the absolute risk of developing wet AMD was still low: 0.2% among those taking a GLP-1 and 0.1% among those who didn't. Do GLP-1 drugs harm eye health? While not definitive, the study raises further questions about the potential risks posed by GLP-1 drugs for eye health. Prior studies have also identified links between GLP-1s and other forms of eye disease in people with type 2 diabetes. In a major phase 3 semaglutide trial in 2016, researchers identified that type 2 diabetes patients taking semaglutide had a higher risk of complications of diabetic retinopathy compared to a placebo. Those findings were published in The New England Journal of Medicine. However, other studies have provided conflicting evidence. A retrospective 2024 study evaluated nearly 700 subjects with type 2 diabetes who were taking a GLP-1 drug and found no association between GLP-1s and worsening retinopathy. Also in 2024, researchers found that patients with type 2 diabetes who were prescribed semaglutide were at greater risk of NAION compared to those who weren't. NAION is a condition that causes sudden blindness, typically just in one eye, due to a lack of blood flow to the optic nerve. The mechanism for why GLP-1 drug use may lead to wet AMD is not well established, but a predominant theory is that lowering blood sugar rapidly leads to a lack of oxygen in the retina. 'When you make the retina more hypoxic, which is what the GLP-1s do, it basically pushes it further over the threshold, causing more abnormal blood vessels to grow,' said Linda Lam, MD, MBA, an ophthalmologist with Keck Medicine of USC, who wasn't involved in the research. Abnormal blood vessel growth in the eye is the hallmark of wet AMD. While GLP-1s offer many health benefits, eye disease risk must be considered in some populations, Lam told Healthline. 'In this particular group of patients who are older, who are diabetics, I really would caution against the extended use of GLP-1s,' she said. Lam reiterated the importance of annual eye exams for the general population, but in particular for those with diabetes, to identify and diagnose eye disease early on. People with type 2 diabetes, especially those taking a GLP-1 drug, should be aware of the signs and symptoms of vision loss and consult with their doctor immediately. These include:
Health Line
03-06-2025
- Health
- Health Line
What Happens If You Stop Eye Injections for Age-Related Macular Degeneration?
There are two types of age-related macular degeneration (AMD): dry AMD and wet AMD. Treatment for both types often involves injecting prescription medications into the eye to help prevent further vision loss. For dry AMD, eye injections can slow atrophy (an area of cell loss) in the eye. For wet AMD, eye injections can reduce the formation and leakage of abnormal blood vessels. What happens if you stop these eye injections? If you have wet AMD, you can't abruptly stop your prescribed eye injections. At your next appointment, you can talk with your doctor about the different protocols for extending and potentially stopping injections. For example, the 'treat-extend-stop' protocol involves extending monthly injections to once every 12 weeks, and then stopping altogether. Your eyes and vision will still need to be monitored to ensure your eyes and current vision are not worsening. New research shows people with wet AMD may be able to safely stop eye injection therapy A retrospective study that examined the treat-extend-stop protocol found that 37.3% of 385 eyes treated for wet AMD met the criteria for stopping injection therapy. Of these 143 eyes, 70.6% required no further intervention. Of those that experienced recurrence, 54.8% recovered their vision to the point when the injections were stopped, after retreatment. In a recent pilot study, researchers discovered that 30% of people with wet AMD may be able to safely stop eye injection therapy without risking further vision loss. The study analyzed treatment outcomes for 106 people with wet AMD between 2013 and 2020. Participants were placed on a closely monitored injection schedule, and researchers determined which participants still required injections and which could be paused. Patients who stopped anti-VEGF treatments in at least one eye showed the best outcome, with less fluid and improved vision compared with those who required continued injections to maintain their vision. Researchers then looked for biomarkers (measurable indicators) that might determine why certain participants could stop injections. They found differences in eye fluid proteins between people who were able to stop treatments and those who required ongoing monthly treatment. While this study's results are promising, you should not stop your prescribed eye injections without first talking with your doctor. These injections are intended to prevent further vision loss, and stopping could jeopardize that goal. Importance of monitoring age-related macular degeneration If you've been diagnosed with age-related AMD, it's important to have your vision monitored regularly to ensure the preservation of the vision you have. If you're receiving injections for dry or wet AMD, talk with your eye doctor about whether you might be able to pause or increase the timing in between injections. They can monitor disease progression and provide the best treatment recommendations for the health of your eyes and vision.
