About Us | ScientistEYPT EyePoint Pharmaceuticals Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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EYP-1901 (DAVIO)
Wet age-related macular degeneration (AMD)
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Phase 1
Phase 1
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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ILUVIEN (Fluocinolone acetonide)
Diabetic macular edema
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Approved
Approved
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CRL Nov 2011. Second CRL Oct 17 2013. Approved Sept 26 2014
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YUTIQ (fluocinolone acetonide intravitreal implant)
Non-infectious uveitis
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Approved
Approved
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FDA approval announced October 15, 2018.
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YUTIQ (fluocinolone acetonide intravitreal implant)
Non-infectious uveitis
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sNDA Filing
sNDA Filing
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sNDA filing planned.
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Latest News
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WATERTOWN, Mass., Aug. 02, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, today announced the formation of its Executive Scientific Advisory Board (SAB), chaired by Dr. Carl Regillo M.D., FACS, Chief of the Retina Service at Wills Eye Hospital. Other members of the SAB include Drs. Sophie J. Bakri, M.D., Mayo Clinic, Caroline R. Baumal, M.D., Tufts Medical Center, David S. Boyer, M.D., University of Southern California Keck School of Medicine, Glenn J. Jaffe, M.D., Duke University, Rishi P. Singh, M.D., Cleveland Clinic, and Charles C. Wykoff, M.D., Ph.D., Retina Consultants of Texas. These prominent retinal surgeons and leaders in the field of vision will work with EyePoint management to advance a pipeline of ocular products that advance the treatment paradigm for better patient outcomes.
"We are very honored to have such distinguished and talented experts sit on EyePoint Pharmaceuticals' executive scientific advisory board," said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals "and it is a testament to the quality of our science and pipeline potential that they are now advising us. Their combined knowledge, insight, experience, and strategic council will prove vital as we approach interim 6-month data for our Phase 1 DAVIO trial of EYP-1901 for the potential treatment of wet-AMD and continue to advance our innovative pipeline of treatments for patients with serious ophthalmic diseases."
Carl D. Regillo, M.D., FACS – Chairman of the Executive Scientific Advisory Board
Dr. Carl D. Regillo is a globally recognized leader in the retinal surgery field, a Professor of Ophthalmology at Thomas Jefferson University, Chief of the Retina Service of Wills Eye Hospital and Founder of the Wills Eye Clinical Retina Research Unit in Philadelphia. He has been an investigator on numerous major clinical trials developing new medical and surgical treatments for retinal disorders such as macular degeneration and diabetic retinopathy. Dr. Regillo has authored over 200 publications along with over 50 book chapters and 9 major books. He is invited to lecture worldwide and serves on the scientific editorial board for several top ophthalmology peer-reviewed journals, and is a recipient of numerous local, national, and international awards including American Academy of Ophthalmology Achievement, Senior Achievement, Secretariat, and Lifetime Achievement Awards and the American Society of Retinal Specialists Honor, Senior Honor and Founders Awards. He is also a charter inductee of the Retina Hall of Fame and named in the Ophthalmologist Power List of the top 100 most influential ophthalmologists in the world. He received his medical degree from Harvard Medical School and performed his ophthalmology residency and vitreoretinal fellowship at Wills Eye Hospital.Sophie J. Bakri, M.D., M.B.A.
Sophie J. Bakri, M.D., M.B.A. is Chair of the Department of Ophthalmology at Mayo Clinic, Rochester, MN and holds the Whitney and Betty MacMillan Professorship in Ophthalmology in Honor of Robert R. Waller, M.D. She has authored over 200 peer-reviewed papers and 26 book chapters. She is a principal investigator on numerous multicenter clinical trials on novel drugs for retinal disease. She serves on the Editorial Board of the American Journal of Ophthalmology, Retina, Seminars in Ophthalmology and OSLI Retina. She has served on committees at the Macula Society, Retina Society and AAO, and is a Board Member of the American Society of Retinal Specialists.Caroline R. Baumal, M.D., FASRS
Caroline R. Baumal, M.D., FASRS is a Professor of Ophthalmology at New England Eye Center, Tufts Medical Center in Boston, MA. She specializes in medical and surgical disorders of the retina and vitreous. Her research interests include novel retinal imaging and drug development. She has been appointed to the ASRS Retina Hall of Fame and was on the Top 100 Female Ophthalmology list from 2021. Dr. Baumal has authored over 165 publications, 28 book chapters on retinal diseases and recently edited the book Treatment of Diabetic Retinopathy.Glenn J. Jaffe, M.D.
Dr. Jaffe is the Robert Machemer Professor of Ophthalmology and a member of the vitreoretinal faculty at Duke University Eye Center. He is chief of the Retina Division, and founded and directs the Duke Reading Center. Dr. Jaffe received his medical degree and his ophthalmology residency training at the University of California, San Francisco. He completed a two-year combined clinical and research vitreoretinal fellowship at the Medical College of Wisconsin. He joined the faculty at Duke University in 1989. Dr. Jaffe serves on the Editorial Board of the journals Retina, Current Opinions in Ophthalmology, and Ocular Surgery News and reviews manuscripts for a variety of clinical and investigative ophthalmology journals.Rishi P. Singh, M.D.
Dr. Rishi P. Singh, M.D. is a staff surgeon at the Cole Eye Institute, Cleveland Clinic and Professor of Ophthalmology at the Lerner College of Medicine in Cleveland Ohio. He also currently serves as the medical director of informatics at the Cleveland Clinic. He specializes in the treatment of medical and surgical retinal disease such as diabetic retinopathy, retinal detachment, and age-related macular degeneration. Dr. Singh has authored more than 190 peer reviewed publications, books, and book chapters and serves as the principal investigator of numerous national clinical trials advancing the treatment of retinal disease. Dr. Singh is the former president on the Retina World Congress and is a board member of the American Society of Retina Specialists.David S. Boyer, M.D.
David S. Boyer, M.D. is a Board-certified ophthalmologist specializing in the treatment of diseases of the retina and vitreous. He is Senior Partner at Retina-Vitreous Associates Medical Group with offices in Los Angeles, Beverly Hills, North Hollywood, Torrance, Pasadena, Tarzana and Glendale, California. Dr. Boyer is an Adjunct Clinical Professor of Ophthalmology with the University of Southern California/Keck School of Medicine in Los Angeles, CA. He is one of the leading retinal clinical researchers in the country for new treatments in macular degeneration and diabetic macular edema.Charles C. Wykoff, M.D., Ph.D.
Charles C. Wykoff, M.D., Ph.D. is Director of the Retina Consultants of Texas Research Centers; Chairman of the Research and Clinical Trials Committee, Retina Consultants of America; and Deputy Chair of Ophthalmology for the Blanton Eye Institute, Houston Methodist Hospital. Dr. Wykoff serves as principal investigator for numerous clinical trials. He has published nearly 200 peer-reviewed manuscripts and frequently speaks at national and international academic meetings. Dr. Wykoff serves on multiple scientific and medical advisory boards, safety monitoring committees, and global steering committees for endeavors spanning the innovative process from early to late stage developments. He is President of the Vit-Buckle Society and serves on the ASRS Board of Directors as Chair of the Practice Management Committee. He has been awarded the ASRS Senior Honor and Young Investigator Awards as well as the AAO Secretariat and multiple Achievement Awards.Additional background information on the SAB members can be found on our website, www.eyepointpharma.com
About EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, a potential twice-yearly intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The Company has two commercial products: YUTIQ®, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU®, for the treatment of postoperative inflammation following ocular surgery. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter and LinkedIn.
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 the anticipated use of proceeds for the proposed offering 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, this includes our expectations regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a novel twice-yearly treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued impact of the COVID-19 pandemic on EyePoint's business, the medical community and the global economy and the impact of general business and economic conditions; our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; our ability to successfully produce sufficient commercial quantities of YUTIQ and DEXYCU and to successfully commercialize YUTIQ and DEXYCU in the U.S.; our ability to sustain and enhance an effective commercial infrastructure and enter into and maintain commercial agreements for YUTIQ and DEXYCU; the development of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; the success of current and future license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; termination or breach of current license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; 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. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Investor Contact:
Christina Tartaglia
Stern IR
Direct: 212-698-8700
[email protected]Media Contact
Green Room Public Relations
Caren Begun
Green Room Communications
Direct: (201) 396-8551
[email protected]
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WATERTOWN, Mass., July 28, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, today announced it will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, August 4, 2021 to report its second quarter 2021 financial results and discuss recent business highlights.
To access the live conference call, please dial (877)-312-7507 (domestic) or (631)-813-4828 (international) and reference conference ID 1861354. 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 Pharmaceuticals
EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) is a pharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for extended intraocular drug delivery including EYP-1901, a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The Company has two commercial products: YUTIQ®, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU®, for the treatment of postoperative inflammation following ocular surgery. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter and LinkedIn.
Investors:
Christina Tartaglia
Stern IR
Direct: (212)-698-8700
[email protected]Media Contact:
Caren Begun
Green Room Communications
Direct: (201)-396-8551
[email protected] -
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WATERTOWN, Mass., July 20, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced today that the Company expects to receive a nine month extension on DEXYCU®'s pass-through payment status, which otherwise would expire on March 31, 2022.
On July 19, 2021, The Centers for Medicare and Medicaid Services (CMS) released its 2022 draft Hospital Outpatient Prospective Payment System (HOPPS) rule, which indicates that CMS plans to extend the pass-through period for select outpatient drugs and device products, such as DEXYCU, due to the public health emergency associated with the COVID-19 pandemic. The draft rules are subject to a public comment period prior to the issuance by CMS of the final 2022 HOPPS rule, which is anticipated in November 2021.
"We are extremely pleased that the CMS has indicated it intends to provide additional pass-through time, subject to public comment, allowing for another nine months of pass through status for important innovative products such as DEXYCU," said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. "The continuation of pass-through status by the CMS is an important step as we continue to execute on our commercial strategy of expanding the use of DEXYCU by physicians for their patients."
Approximately 60% of patients who undergo cataract surgery are covered by Medicare Part B. Drugs that are administered as part of the cataract surgery procedure can be covered under a CMS administered transitional-pass-through payment. The pass-through payment was established by the U.S. government to help foster innovative drug development. Drug applications must meet certain qualifications for inclusion. The transitional pass-through status is typically three years.
About EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, a potential twice-yearly intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The Company has two commercial products: YUTIQ®, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU®, for the treatment of postoperative inflammation following ocular surgery. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter and LinkedIn.
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 the anticipated use of proceeds for the proposed offering 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, this includes the continued impact of the COVID-19 pandemic on EyePoint's business, the medical community and the global economy and the impact of general business and economic conditions, our expectations regarding the timing and clinical development of our product candidates, including EYP-1901; and the potential for EYP-1901 as a novel twice-yearly treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; our ability to successfully produce sufficient commercial quantities of YUTIQ and DEXYCU and to successfully commercialize YUTIQ and DEXYCU in the U.S.; our ability to sustain and enhance an effective commercial infrastructure and enter into and maintain commercial agreements for YUTIQ and DEXYCU; the development of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; the success of current and future license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; termination or breach of current license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; 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. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Investors:
Christina Tartaglia
Stern IR
Direct: 212-698-8700
[email protected]Media Contact
Green Room Public Relations
Caren Begun
Green Room Communications
Direct: (201) 396-8551
[email protected] -
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WATERTOWN, Mass., July 06, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced positive safety results from its Phase 1 clinical trial of EYP-1901, a potential twice-yearly sustained delivery anti-VEGF treatment targeting wet age-related macular degeneration (wet AMD). All dose cohorts have reached at least 30-day post-dosing follow up.
"We are pleased by the 30-day safety data seen for all three cohorts of the EYP-1901 DAVIO trial in patients with wet AMD," said Nancy Lurker, CEO of EyePoint Pharmaceuticals. "These early results continue to support our belief in the potential of EYP-1901 to be a safe and effective therapeutic for long-term treatment of wet AMD. We are looking forward to releasing interim efficacy results once we have sufficient follow-up data for all dose cohorts in the fourth quarter of this year. Additionally, we continue to progress toward initiating our clinical trials of EYP-1901 for diabetic retinopathy and retinal vein occlusion."
The DAVIO clinical trial of EYP-1901 enrolled 17 wet AMD patients across three dose cohorts. Key safety observations through at least 30-Day post-dosing follow-up for all patients include:
- No serious adverse events (SAEs), ocular or systemic, were reported
- The three subjects in cohort 1 have been followed for a minimum of four months with no reported SAE's
- To date, there are no reported adverse events (AEs) related to significant intraocular inflammation, best-corrected visual acuity (BCVA) reduction, or elevation of intraocular pressure (IOP)
- No events of endophthalmitis, retinal detachment or migration into the anterior chamber have been reported to date
The patients enrolled in the Phase 1 DAVIO open-label, dose escalation trial were previously treated with standard of care anti-VEGF therapies. EYP-1901 is delivered via a single intravitreal injection in the physician's office. The primary endpoint of the trial is safety, and key secondary endpoints are best corrected visual acuity (BCVA) and central subfield thickness (CST) as measured by optical coherence tomography (OCT).
EYP-1901 utilizes the Company's proprietary Durasert® drug delivery technology that has been used in four FDA-approved products, including EyePoint's YUTIQ® for chronic non-infectious uveitis affecting the posterior segment of the eye.
About EYP-1901
EYP-1901 is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration. EYP-1901 combines a bioerodible formulation of EyePoint's proprietary Durasert® sustained release technology with vorolanib, a tyrosine kinase inhibitor. Vorolanib provided clear efficacy signals in two prior human trials in wet AMD as an orally delivered therapy with no significant ocular adverse events. Preclinical studies of EYP-1901 have shown anti-VEGF activity in disease models of ocular neovascularization and no serious safety issues were observed. EYP-1901 is initially being developed as a treatment of wet AMD, with the potential for additional indications in diabetic retinopathy and retinal vein occlusion.
About EyePoint Pharmaceuticals, Inc.
EyePoint Pharmaceuticals (NASDAQ:EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, a potential twice-yearly intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The Company has two commercial products: YUTIQ®, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU®, for the treatment of postoperative inflammation following ocular surgery. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter and LinkedIn.
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 the anticipated use of proceeds for the proposed offering 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, this includes our expectations regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a novel twice-yearly treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued impact of the COVID-19 pandemic on EyePoint's business, the medical community and the global economy and the impact of general business and economic conditions; our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; our ability to successfully produce sufficient commercial quantities of YUTIQ and DEXYCU and to successfully commercialize YUTIQ and DEXYCU in the U.S.; our ability to sustain and enhance an effective commercial infrastructure and enter into and maintain commercial agreements for YUTIQ and DEXYCU; the development of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; the success of current and future license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; termination or breach of current license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; 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. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Investors:
Christina Tartaglia
Stern IR
Direct: 212-698-8700
[email protected]Media Contact
Green Room Public Relations
Caren Begun
Green Room Communications
Direct: (201) 396-8551
[email protected] -
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WATERTOWN, Mass., July 01, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced today that the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel accepted the addition of a new Category III CPT code, 0X78T for the administration of a drug into the posterior chamber of the anterior segment of the eye, effective January 1, 2022, providing an opportunity for a reimbursement pathway for the administration of DEXYCU.
"We are pleased by the AMA's approval of this new Category III code, which we believe will provide physicians with an opportunity for a reimbursement pathway for intraocular procedures, including DEXYCU," said Scott Jones, Chief Commercial Officer of EyePoint Pharmaceuticals. "DEXYCU is the first and only FDA-approved, single dose, sustained-release, intracameral steroid for the treatment of postoperative inflammation. We believe the new code is an important step toward increased adoption of DEXYCU."
Category III CPT codes are temporary codes for emerging technologies, services and procedures intended to be used for specific data collection or documentation. Inclusion or exclusion of a procedure or service does not imply any health insurance coverage or reimbursement policy.
About EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, a potential twice-yearly intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. The Company has two commercial products: YUTIQ®, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU®, for the treatment of postoperative inflammation following ocular surgery. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter and LinkedIn.
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 the anticipated use of proceeds for the proposed offering 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, this includes the continued impact of the COVID-19 pandemic on EyePoint's business, the medical community and the global economy and the impact of general business and economic conditions, our expectations regarding the timing and clinical development of our product candidates, including EYP-1901; and the potential for EYP-1901 as a novel twice-yearly treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; our ability to successfully produce sufficient commercial quantities of YUTIQ and DEXYCU and to successfully commercialize YUTIQ and DEXYCU in the U.S.; our ability to sustain and enhance an effective commercial infrastructure and enter into and maintain commercial agreements for YUTIQ and DEXYCU; the development of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; the success of current and future license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; termination or breach of current license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; 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. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Investors:
Christina Tartaglia
Stern IR
Direct: 212-698-8700
[email protected]Media Contact
Green Room Public Relations
Caren Begun
Green Room Communications
Direct: (201) 396-8551
[email protected]