Fluocinolone acetonide micro-insert intravitreous implant

ILUVIEN now approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addition to diabetic macular edema (DME)ANI plans to begin marketing ILUVIEN in the U.S. under the combined label later this year BAUDETTE, Minn., March 14, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for ILUVIEN (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The approval also includes other updates to the label including to the Warnings and Precautions section. As previously announced, the Company plans to market ILUVIEN for chronic NIU-PS in addition to its current indication of diabetic macular edema (DME) in the U.S. ILUVIEN is already approved for both DME and NIU-PS outside the U.S., including in seventeen European countries. Nikhil Lalwani, President and CEO of ANI stated, “ILUVIEN’s expanded label and the strengthening of our partnership with long-standing ILUVIEN contract manufacturer, Seigfried, will enhance supply security and access for appropriate NIU-PS and DME patients in need.” ANI previously announced that it extended its supply agreement for ILUVIEN with a subsidiary of Siegfried Holding AG (Seigfried) through 2029. Siegfried and ANI also agreed to upgrade equipment on the existing manufacturing line and significantly expand capacity. INDICATIONSILUVIEN is a corticosteroid indicated for: the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS ILUVIEN is contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.ILUVIEN is contraindicated in patients with glaucoma who have cup to disc ratios of greater than 0.8.ILUVIEN is contraindicated in patients with known hypersensitivity to any components of this product. WARNINGS AND PRECAUTIONS Intravitreal Injection-related Effects: Intravitreal injections, including those with ILUVIEN, have been associated with endophthalmitis, eye inflammation, increased or decreased intraocular pressure, and choroidal or retinal detachments. For patients with non-infectious uveitis affecting the posterior segment, hypotony has been observed within 24 hours of injection and has resolved within 2 weeks. Patients should be monitored following the intravitreal injection. Patients may experience temporary blurred vision after injection of the implant.Intraocular Pressure (IOP) Increase: Prolonged use of corticosteroids may result in the development of glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be routinely monitored during the course of the treatment.Cataracts: Use of corticosteroids including ILUVIEN may produce posterior subcapsular cataracts.Delayed Corneal Wound Healing: The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation.Corneal and Scleral Melting: Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of ophthalmic corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation of the globe.Bacterial Infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. Acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated.Viral Infections: Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.Fungal Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.Risk of Implant Migration: Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber. ADVERSE REACTIONSDiabetic Macular EdemaOcular adverse reactions reported by greater than or equal to 1% of patients in the two combined 3-year clinical trials following injection of ILUVIEN for diabetic macular edema include: cataract (82%), myodesopsia (21%), eye pain (15%), conjunctival hemorrhage (13%), posterior capsule opacification (9%), eye irritation (8%), vitreous detachment (7%), conjunctivitis (4%), corneal oedema (4%), foreign body sensation in eyes (3%), eye pruritus (3%), ocular hyperaemia (3%), optic atrophy (2%), ocular discomfort (2%), photophobia (2%), retinal exudates (2%), anterior chamber cell (2%), and eye discharge (2%). Non-ocular adverse reactions reported by greater than or equal to 5% of patients include: anemia (11%), headache (9%), renal failure (9%), and pneumonia (7%) Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 34% of ILUVIEN patients versus 10% of sham patients. IOP elevation greater than or equal to 30 mm Hg was seen in 20% of ILUVIEN patients versus 4% of sham patients. 38% of the patients who received ILUVIEN were subsequently treated with IOP-lowering medications during the study versus 14% of sham patients. 5% of the patients who received ILUVIEN needed surgical intervention for elevated IOP versus 1% of sham patients Cataracts and Cataract Surgery: The incidence of cataract development in patients who had a phakic study eye was higher in the ILUVIEN group (82%) compared with Sham (50%). The median time of cataract being reported as an adverse event was approximately 12 months in the ILUVIEN group and 19 months in the Sham group. Among these patients, 80% of ILUVIEN subjects versus 27% of sham-controlled subjects underwent cataract surgery, generally within the first 18 Months (Median Month 15 for both ILUVIEN group and for Sham) of the studies. Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the EyeOcular adverse reactions reported by greater than or equal to 1% of patients in the three combined clinical trials through 12 months following injection of fluocinolone acetonide intravitreal implant: cataract (56%), visual acuity reduced (15%), macular edema (11%), uveitis (10%), conjunctival hemorrhage (8%), eye pain (8%), hypotony of eye (7%), anterior chamber inflammation (5%), dry eye (4%), vitreous opacities (4%), conjunctivitis (4%), posterior capsule opacification (4%), ocular hyperemia (4%), vitreous haze (3%), foreign body sensation in eyes (3%), vitritis (3%), vitreous floaters (3%), eye pruritus (3%), conjunctival hyperemia (2%), ocular discomfort (2%), macular fibrosis (2%), glaucoma (2%), photopsia (2%), vitreous hemorrhage (2%), iridocyclitis (1%), eye inflammation (1%), choroiditis (1%), eye irritation (1%), visual field defect (1%), and lacrimation increased (1%). Non-ocular adverse reactions reported by greater than or equal to 2% of patients include: nasopharyngitis (5%), hypertension (3%), and arthralgia (2%). Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 22% of fluocinolone acetonide patients versus 12% of sham patients. IOP elevation greater than or equal to 30 mm Hg was seen in 12% of fluocinolone acetonide patients versus 3% of sham patients. 43% of the patients who received fluocinolone acetonide were subsequently treated with IOP-lowering medications during the study versus 41% of sham patients. 2% of the patients who received fluocinolone acetonide needed surgical intervention for elevated IOP versus 2% of sham patients. Please see full Prescribing Information. About ANI ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit www.anipharmaceuticals.com. Forward-Looking Statements To the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, 2025 guidance, other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates. Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. Uncertainties and risks include, but are not limited to: the ability of our approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, to achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; our ability to complete or achieve any, or all of the intended benefits of acquisitions and investments, including the acquisition of Alimera, in a timely manner or at all; the limitation of our cash flow as a result of the indebtedness and liabilities incurred from the recent acquisition of Alimera; the risks that our acquisitions and investments, including the recent acquisition of Alimera, could disrupt our business and harm our financial position and operating results; delays and disruptions in production of our approved products, increased costs and potential loss of revenues if we need to change suppliers due to the limited number of suppliers for our raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in production of our approved products as a result of our reliance on single source third party contract manufacturing supply for certain of our key products, including Cortrophin Gel, ILUVIEN and YUTIQ; delays or failure in obtaining and maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies, and the focus of the current U.S. presidential administration, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; risks that we may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of our products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the ability of our manufacturing partners to meet our product demands and timelines; the impact of changes or fluctuations in exchange rates; our ability to develop, license or acquire, and commercialize new products; our obligations in agreements under which we license, develop or commercialize rights to products or technology from third parties and our ability to maintain such licenses; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the Ukraine, the conflict in the Middle East, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies, and other risks and uncertainties that are described in ANI’s Annual Report on Form 10-K, quarterly reports on Form 10-Q, and other periodic reports filed with the Securities and Exchange Commission. More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (SEC), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Contact Lisa M. Wilson, In-Site Communications, Inc. 212-452-2793 lwilson@insitecony.com SOURCE: ANI Pharmaceuticals, Inc.

– Enrollment exceeding expectations in DURAVYU™ Phase 3 wet AMD clinical trials with LUGANO over 50% enrolled and LUCIA recruiting ahead of schedule – – Positive Phase 2 VERONA clinical trial of DURAVYU for DME met primary and secondary endpoints – – $371 million of cash and investments on December 31, 2024 , providing cash runway into 2027 beyond topline DURAVYU Phase 3 wet AMD data expected in 2026 – WATERTOWN, Mass. , March 05, 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 fourth quarter and full-year ended December 31, 2024, and highlighted recent corporate developments. “We are off to a strong start in 2025, as we advance our best-in-class sustained delivery therapy DURAVYU across clinical programs in the two largest retinal disease markets, wet age-related macular degeneration (AMD) and diabetic macular edema (DME),” said Jay Duker , M.D., President and Chief Executive Officer of EyePoint. “Notably, enrollment in both the LUGANO and LUCIA Phase 3 clinical trials in wet AMD continues to exceed our expectations with LUGANO well over 50% enrolled. We remain on track for enrollment completion for both trials in the second half of 2025, with topline data anticipated in 2026. Additionally, we recently reported excellent 24-week results from our VERONA trial for DURAVYU in DME, meeting the primary endpoint and demonstrating early and sustained improvement in BCVA and CST in an active disease population. These results give us confidence in DURAVYU’s potential as a blockbuster drug poised to potentially redefine the treatment paradigm in two prevalent diseases. With a world-class leadership team, a clear and well-established regulatory path in wet AMD, and a strong balance sheet, we are well positioned as the leader in sustained ocular drug delivery.” R&D Highlights and Updates Global Phase 3 LUGANO and LUCIA pivotal trials of DURAVYU in wet AMD well underway with both trials exceeding expectations. The LUGANO trial is over 50% enrolled, significantly exceeding observed historical enrollment rates of both comparable and competitive wet AMD trials. We remain on-track to complete enrollment of both trials in the second half of 2025 with topline data anticipated in 2026. The non-inferiority trials include six-month re-dosing and follow a clear and recognized pathway for potential global regulatory and commercial success. In March 2025 , we presented positive 24-week supplement-free patient subgroup analyses from the Phase 2 VERONA clinical trial in DME demonstrating that DURAVYU 2.7mg significantly improved vision and fluid versus baseline compared to the aflibercept control group, including: BCVA improvement of +10.3 letters versus +3.0 letters for aflibercept control CST improvement of 117.4 microns versus 43.7 microns for aflibercept control 43% had an absence of DME compared to zero for the aflibercept control arm. BCVA improvement of +10.3 letters versus +3.0 letters for aflibercept control CST improvement of 117.4 microns versus 43.7 microns for aflibercept control 43% had an absence of DME compared to zero for the aflibercept control arm. These results confirm that the positive data from the Phase 2 VERONA trial were driven by DURAVYU. In February 2025 , we announced positive topline 24-week data for the Phase 2 VERONA clinical trial of DURAVYU for DME meeting primary and secondary endpoints. Visual and anatomical gains were observed as early as Week 4 compared to aflibercept control, demonstrating the immediate bioavailability of DURAVYU and its differentiated profile as a sustained-release TKI. The DURAVYU treatment arms demonstrated a continued favorable safety and tolerability profile. Presented datasets at key medical conferences that highlight the meaningful efficacy, strong durability and continued safety of DURAVYU. Presentations included: Phase 2 DAVIO 2 12-month clinical trial results for DURAVYU in wet AMD at the Hawaiian Eye & Retina annual meeting in January. DAVIO 2 end-of-trial results and 16-week interim results from the VERONA trial in DME at Angiogenesis, Exudation, and Degeneration 2025 in February. An assessment showcasing the meaningful reduction in treatment burden in wet AMD patients treated with DURAVYU versus aflibercept at the Macula Society Annual Meeting in February. Accepted to present at the upcoming 2025 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in May, showcasing EyePoint’s robust dataset across multiple indications with continued best-in-class safety and efficacy, as well as the program’s de-risked study designs that reflect real-world patient populations. Phase 2 DAVIO 2 12-month clinical trial results for DURAVYU in wet AMD at the Hawaiian Eye & Retina annual meeting in January. DAVIO 2 end-of-trial results and 16-week interim results from the VERONA trial in DME at Angiogenesis, Exudation, and Degeneration 2025 in February. An assessment showcasing the meaningful reduction in treatment burden in wet AMD patients treated with DURAVYU versus aflibercept at the Macula Society Annual Meeting in February. Recent Corporate Highlights Announced the appointment of renowned retina specialist and industry leader Reginald J. Sanders M.D ., FASRS to the Company’s Board of Directors in January. Review of Results for the Fourth Quarter Ended December 31, 2024 For the fourth quarter ended December 31, 2024 , total net revenue was $11.6 million compared to $14.0 million for the quarter ended December 31, 2023 . Net product revenue for the fourth quarter was $0.8 million , compared to net product revenue for the corresponding period in 2023 of $0.7 million . Net revenue from license and royalties for the fourth quarter ended December 31, 2024 , totaled $10.8 million compared to $13.3 million in the corresponding period in 2023. The decrease was primarily driven by lower recognition of deferred revenue from the license of YUTIQ product rights. Operating expenses for the fourth quarter ended December 31, 2024 , totaled $56.8 million versus $30.4 million in the prior year period. This increase was primarily driven by the two ongoing Phase 3 trials for DURAVYU. Net non-operating income totaled $3.9 million and net loss was $41.4 million , or ( $0.64 ) per share, compared to a net loss of $14.1 million , or ( $0.33 ) per share, for the prior year period. Review of Results for the Full Year Ended December 31, 2024 For the full year ended December 31, 2024, total net revenue was $43.3 million compared to $46.0 million for the year ended December 31, 2023. Net product revenue for the full year ended December 31, 2024, was $3.2 million, compared to $14.2 million for the full year ended December 31, 2023. The decrease in net product revenue was driven by license of YUTIQ product rights sold in May 2023 completing EyePoint’s exit from its commercial business. Net revenue from license and royalties for the full year ended December 31, 2024, totaled $40.1 million compared to $31.8 million in the corresponding period in 2023. The increase was primarily driven by higher recognition of deferred revenue from the license of YUTIQ product rights in 2023. Operating expenses for the full year ended December 31, 2024, totaled $189.1 million versus $121.1 million in 2023. This increase was attributable primarily to (i) $26.6 million in increased clinical trial costs, related to the Phase 3 clinical trials of DURAVYU, (ii) $28.0 million of increased personnel related costs across the organization, including a $24.7 million increase of non-cash stock-based compensation, (iii) $16.7 million in DURAVYU non-clinical and license expense. These increases were offset by $3.3 million decrease primarily driven by a reduction in other sales and marketing expenses due to discontinuation of YUTIQ commercialization activities. Net non-operating income totaled $15.1 million and net loss was $130.9 million, or ( $2.32 ) per share, compared to a net loss of $70.8 million, or ( $1.82 ) per share, for the prior year period. Cash, cash equivalents, and investments in marketable securities on December 31, 2024, totaled $371 million compared to $331 million as of December 31, 2023. Financial OutlookWe expect the cash, cash equivalents, and investments on December 31, 2024 , will enable us to fund operations into 2027 beyond topline Phase 3 data for DURAVYU in wet AMD expected in 2026. Accordingly, we currently have no plans to access the equity capital markets in 2025. Conference Call Information EyePoint will host a conference call today at 8:30 a.m. ET to discuss the results for the fourth quarter and full-year ended December 31, 2024 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BI804e9c71d61543cab2c16376caae4936. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call. About EyePoint EyePoint (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™ is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. Supported by robust safety and efficacy data to date, DURAVYU is presently in Phase 3 global, pivotal clinical trials for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States and recently completed a Phase 2 clinical trial in diabetic macular edema (DME). Based on positive Phase 2 results from the VERONA clinical trial in DME, EyePoint anticipates meeting with U.S. and ex- U.S. regulatory agencies in the second quarter of 2025 to confirm plans for a pivotal program. Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products in multiple disease indications. EyePoint Pharmaceuticals is headquartered in Watertown, 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; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. Forward Looking Statements 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 our expectations regarding the timing and clinical development and potential of DURAVYU in DME and wet AMD, including our expectations regarding the VERONA trial following our announcement of full topline data and the progress of our ongoing LUGANO and LUCIA trials; our beliefs and expectations that the full topline results from the VERONA trial support DURAVYU’s potential to advance to non-inferiority pivotal trials; the potential for DURAVYU 2.7mg to extend treatment intervals while improving vision without sacrificing anatomy; the potential for DURAVYU to provide an immediate benefit over aflibercept control in both BCVA and CST; our optimism that that DURAVYU has the potential to shift the treatment paradigm in DME and improve patient outcomes; our expectations regarding clinical development of our other product candidates, including EYP-2301; our business strategies and objectives; 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, these risks and uncertainties include the timing, progress and results of the company’s clinical development activities; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; 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; 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. 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: Christina Tartaglia Precision AQ Direct: 212-698-8700christina.tartaglia@precisionaq.com Media Contact: Amy Phillips Green Room Communications Direct: 412-327-9499aphillips@greenroompr.com Source: EyePoint Pharmaceuticals, Inc.