Epiretinal Membrane

LA JOLLA, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced it has received a Notice of Allowance from the Japan Patent Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of macular injury associated with progressive multiple sclerosis. Once issued, this patent is expected to expire no earlier than October 2039. The allowed claims cover the use of MN-166 (ibudilast) for treating macular injury associated with progressive multiple sclerosis and for decreasing macular volume loss associated with progressive multiple sclerosis. The allowed claims specifically cover both primary progressive multiple sclerosis and secondary progressive multiple sclerosis. The allowed claims cover oral administration including tablets, capsules, granules, microbead dosage forms, and liquid dosage forms. The allowed claims cover a wide range of doses of MN-166 (ibudilast), a range of different dosing frequencies, and a range of different treatment periods. Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, “We are very pleased to receive a notice of this new patent allowance in Japan and we believe it could increase the potential value of MN-166. The potential of MN-166 in ophthalmic neurodegenerative diseases has been demonstrated previously by positive data from a glaucoma animal model study and a retinal damage animal model study. Previously, we reported positive Optical Coherence Tomography (OCT) results from the SPRINT-MS Phase 2b trial of MN-166 in progressive multiple sclerosis. All OCT measures showed less loss of retinal tissue for MN-166 compared to placebo. Similar patents have been granted in the U.S., Europe, and China.” About MN-166 (ibudilast) MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety pro MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2022 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT: Geoff O'Brien Vice President MediciNova, Inc. info@medicinova.com

ALPHARETTA, Ga., April 05, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today announced the appointment of Arshad M. Khanani, M.D., M.A, F.A.S.R.S and Lejla Vajzovic, M.D., F.A.S.R.S to its Scientific Advisory Board (SAB). Clearside’s SAB is comprised of industry leading retinal physicians who provide medical and scientific expertise and input on the Company’s research and development programs. The SAB members are: Thomas A. Ciulla, M.D., M.B.A., ChairDavid S. Boyer, M.D.David M. Brown, M.D.Arshad M. Khanani, M.D., M.A., F.A.S.R.S.Carl D. Regillo, M.D., F.A.C.S Lejla Vajzovic, M.D., F.A.S.R.S. “We are honored to have these esteemed clinicians provide valuable feedback as we advance our CLS-AX program in neovascular age-related macular degeneration (wet AMD) and explore broader uses for SCS delivery,” stated George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. “Drs. Khanani and Vajzovic will greatly complement our highly experienced SAB, led by Dr. Thomas Ciulla as Chair. We would also like to thank Dr. Nancy Holekamp and Dr. Peter Kaiser for their valuable service as they transition off the SAB due to other professional commitments. Our Scientific Advisory Board is integral in providing real-world insights to our team as we work to leverage our suprachoroidal delivery platform to potentially preserve and improve vision in patients with sight-threatening eye diseases.” Biographies of New SAB Members: Arshad M. Khanani, M.D., M.A., F.A.S.R.S. Arshad M. Khanani, M.D., M.A., F.A.S.R.S. is a Managing Partner, Director of Clinical Research, and Director of Fellowship at Sierra Eye Associates and Clinical Associate Professor at the University of Nevada, Reno School of Medicine. Dr. Khanani founded the clinical research department at Sierra Eye Associates, which is now one of the leading clinical research centers in the country. He has served as a principal investigator for over 100 clinical trials and has been a top enroller in the country for multiple Phase 1-3 trials. In addition, Dr. Khanani has been the first to perform surgical procedures in multiple surgical clinical trials which deal with sustained delivery and gene therapy. He has written or contributed to over 90 scientific publications. Dr. Khanani also serves as a member of national and international clinical trial steering committees as well as scientific advisory boards with the goal of bringing new treatment options for patients with retinal diseases. Dr. Khanani is frequently invited as a guest speaker at national and international meetings. Dr. Khanani is an elected member of the Macula Society, Retina Society and has received numerous awards of distinction. In 2019, he received the Nevada Business Magazine Healthcare Heroes Physician of the Year award for his continued dedication to the field of ophthalmology. He has received the Senior Honor Award from the American Society of Retina Specialists (ASRS) and was also awarded the prestigious ASRS Presidents’ Young Investigator Award in 2021. Lejla Vajzovic, M.D., F.A.S.R.S. Lejla Vajzovic, M.D., F.A.S.R.S. is the Director of Duke Vitreoretinal Fellowship Program and is a tenured Associate Professor of Ophthalmology at Duke University. Dr. Vajzovic is a vitreoretinal surgeon with expertise in adult and pediatric retinal diseases and surgery. She is passionate about translational research and collaborates closely with Duke Biomedical engineers to develop imaging devices to improve ophthalmic care. She serves as a principal investigator for numerous national clinical trials in early to late stages of development. Her research interests span from pediatric retinal diseases such as retinopathy of prematurity to adult diseases such as age-related macular degeneration, diabetic retinopathy and venous occlusive diseases, as well as vitreoretinal surgical topics such as retinal tears, retinal detachments, macular holes and macular puckers. In addition, Dr. Vajzovic is interested in cutting edge technologies and recovery of vision in hereditary and common retinal diseases with gene-therapy, stem cell technology and retinal implants. She is a co-director of the Duke Pediatric Retina and Optic Nerve Center, and she directs the Duke Center for Artificial and Regenerative Vision, where she performs gene-therapy delivery and implants the Argus II “bionic eye” to restore vision to individuals with total blindness. An influential educator, she organizes and directs several highly successful national and international courses, including the first-of-its-kind Advances in Pediatric Retina Course at Duke and the international Duke Fellows Advances in Vitreous Surgery Course. She is director of prestigious Duke Vitreoretinal Surgical Fellowship and director of Duke Eye Center’s Continuing Medical Education program. Dr. Vajzovic completed her vitreoretinal fellowship training at Duke and residency training at Bascom Palmer Eye Institute in Miami, FL. While in training, she received the Heed Fellowship Award, Society of Heed Fellows Award and Retina Society Research Award. She is active on the Women in Ophthalmology Board of Directors where she serves as a Treasurer and a Chair of Clinical Trial Training Program. In addition, she serves as a Retina Society AAO Council Representative. She is an elected member of the Retina Society, Macula Society and Club Jules Gonin Society. Dr. Vajzovic has been awarded the American Academy of Ophthalmology Achievement Award, American Society of Retina Specialists Senior Honor Award, Women in Ophthalmology Emerging Leader Award and Emerging Leader Award by Duke University School of Medicine and Duke Medical Alumni Association. About Clearside Biomedical Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Clearside’s SCS injection platform, utilizing the Company’s proprietary SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector and strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. Clearside’s first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, is commercially available in the U.S. For more information, please visit www.clearsidebio.com. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the clinical development of Clearside’s product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission (SEC) on March 14, 2023, and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor and Media Contacts: Jenny Kobin Remy Bernarda ir@clearsidebio.com(678) 430-8206 Source: Clearside Biomedical, Inc.

The opening of the Hilton Head Retina Institute in Hilton Head, South Carolina, has just been announced. The new retina specialist practice will be overseen by the respected ophthalmologist Dr. Baker. Hilton Head, United States, May 11, 2021 (GLOBE NEWSWIRE) -- Dr. Carl Baker has just announced that he is opening a retina specialist medical practice named the Hilton Head Retina Institute in Hilton Head, South Carolina. For more information, visit The opening of the new retina specialist clinic will help patients in Hilton Head access the latest, high-quality treatments for various retinal conditions. According to Dr. Baker, doctors have developed several new treatments with better outcomes over the last 15 years. Indeed, ophthalmologists can maintain driving-level vision in 80-85% patients with retinal problems, compared to just 5-10% a decade ago. Moreover, many surgical treatments have been replaced with non-invasive medicines. Despite these advances, however, conditions such as macular degeneration and diabetic retinopathy require advanced surgical treatment. Dr. Baker responds to these trends by establishing his retina specialist practice, making these highly advanced treatments available to patients in Hilton Head, SC. The practice will provide patients with the latest diagnostic equipment and treatment options for macular degeneration, diabetic retinopathy and retinal vascular diseases. The clinic will also offer surgical treatments for retinal tears, detachments, macular pucker, dislocated and defective intra-ocular lens implants and vitreous diseases and floaters. In addition to treating patients at his practice, Dr. Baker is currently conducting clinical research for retinal vein occlusions, macular degeneration and diabetic retinopathy. This extensive research expertise will enable Dr. Baker to provide his patients with the most up-to-date treatments. Prior to opening the Hilton Head Retina Institute, Dr. Baker practiced at the Paducah Retinal Center in Western Kentucky for more than 20 years. This latest announcement is in line with Dr. Baker’s commitment to providing personalized, compassionate care to patients using the latest technology and surgical techniques. A spokesperson for the practice said: “Dr. Baker is looking forward to overcoming the challenges of the pandemic and establishing a high-quality institute to treat retinal diseases on Hilton Head Island with comprehensive surgical and medical treatments supported by clinical research.” Interested parties can book an appointment by calling (843) 715-2424 or by visiting the practice’s website at Name: Carl Baker MD Organization: Hilton Head Retina Institute Address: 15 Lafayette Place Suite C, Hilton Head, SC 29926-2277, United States Phone: +1-843-715-2424