Inspire Pharmaceuticals, Inc.

TEL-AVIV, Israel, May 28, 2024 /PRNewswire/ -- Tarsier Pharma, Ltd, a late-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies for the treatment of blinding ocular diseases proudly announces the appointment of Emilee Fulcher as Vice President of Clinical Affairs. Continue Reading Emilee Fulcher, VP Clinical Affairs, Tarsier Pharma Ltd. In her new role, Emilee Fulcher will spearhead the execution of the TRS01 and TRS02 clinical programs towards the advancement of Tarsier Pharma's pipeline for Dazdotuftide (TRS). Dazdotuftide is a novel, multi-target drug with a unique mechanism of action in development for the treatment of ocular blinding diseases as an eye drop formulation (TRS01) and slow-release biodegradable intravitreal injection (TRS02). "We are thrilled to welcome Emilee to the Tarsier team as our Vice President of Clinical Affairs," said Daphne Haim-Langford CEO of Tarsier. "Emilee's exceptional leadership, proven track record, and deep understanding of ophthalmic research make her the ideal candidate to lead our clinical development efforts. She is knowledgeable, professional, deeply compassionate, and fully aligned with the company's vision to save sight, which makes her an invaluable asset to the team". Emilee has 20 years of experience in the pharmaceutical industry with a specialized background in executing ophthalmology clinical trials. Prior to joining Tarsier, Emilee was one of the first employees of Lexitas, an ophthalmic-focused CRO. During her 11-year tenure at Lexitas she successfully led trials spanning across multiple ophthalmic indications and phases, including all three trials in the TRS01 clinical program completed to-date. Prior to that, she held positions in preclinical drug development and in clinical operations at UCB Biosciences and Inspire Pharmaceuticals. Emilee stated "I am deeply honored to officially join the talented team at Tarsier and am excited to leverage my expertise as we strive to bring our innovative treatment to patients. I am passionate about our mission at Tarsier and eager to progress our clinical programs that have the potential to revolutionize the treatment paradigm for patients with debilitating and blinding conditions including uveitis and specifically uveitic glaucoma. As we embark on initiating the Tarsier-04 Phase 3 trial, we are poised to build on the momentum of our recently completed TRS4Vision Phase 3 trial that demonstrated the potential of TRS01 to serve as an effective and safe treatment in uveitis that meets the urgent need for a drug that resolves inflammation and with a superior IOP safety profile." Tarsier Pharma congratulates Emilee Fulcher on her appointment and looks forward to her leadership in driving the company's clinical development efforts forward. Photo: Contact: Investor Relations Tarsier Pharma [email protected] SOURCE Tarsier Pharma

Mr. Schachle Brings Over 30 Years of Experience in Biotech and Pharma with Expertise Across Multiple Functional Areas Including Corporate and Commercial OperationsFARMINGTON HILLS, Mich., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced the appointment of Joseph (Joe) K. Schachle, M.B.A., into the newly created role of Chief Operating Officer, effective today. “Joe is a highly accomplished pharmaceutical executive, and we are thrilled to welcome him to Ocuphire as Chief Operating Officer,” said Dr. George Magrath, CEO of Ocuphire. “His appointment is part of a broader strategic initiative to expand our senior team as we plan for advancement of our lead retina asset, APX3330, into registrational studies and prepare the company for success. Joe brings diverse experience, including in ophthalmology, from some of the world’s leading life science companies. He has held senior roles across multiple functional areas including operations, sales and marketing. He has a strong track record in creating strategic alignment and propelling execution across different organizational structures, experience that will be valuable to Ocuphire’s ongoing and future initiatives.” Joseph Schachle commented, “Joining Ocuphire at this transformational stage as the company pioneers the development of an oral therapy for diabetic retinopathy is an exciting new chapter in my career. I am very pleased to lead operations at a company that is committed to improving standards of eye care. I am eager to collaborate with my new colleagues as we prepare Ocuphire for the next stage of growth.” Mr. Schachle was most recently Chief Operating Officer of Opus Genetics, a gene therapy company focused on rare, inherited retinal diseases. In this role, he managed multiple corporate functions including human resources, finance, legal, investor relations, facilities, information technology, and commercial. He was employed at Grifols from 2013 to 2014 and again from 2017 to 2021 where he held various senior positions including Head of Global Marketing Operations and Vice President of Customer Experience Enablement. From 2014 to 2017, he served as Chief Operating Officer at Parion Sciences. From 2001 to 2002 and 2003 to 2011, he was employed at Inspire Pharmaceuticals where he oversaw multiple partnering deals and promoted three eye care brands. Inspire was acquired by Merck in 2011, and Mr. Schachle led the integration efforts at the time of this transaction. From 2002 to 2003, he was employed at MedImmune as Director of Anti-Infective Marketing. Prior to that, from 1992 to 2001, he was employed at GSK where he held various marketing roles across respiratory, CNS, oncology and HIV. Mr. Schachle received an MBA from Old Dominion University, VA, and a BBA in Marketing from James Madison University, VA. About Ocuphire Pharma Ocuphire Pharma, Inc. is a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders. Ocuphire’s lead retinal product candidate, APX3330, is a first-in-class small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref-1 is a regulator of the transcription factors HIF-1a and NF-kB. Inhibiting REF-1 reduces levels of vascular endothelial growth factor (“VEGF”) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. Through inhibition of Ref-1, APX3330 normalizes the levels of VEGF to physiologic levels, unlike biologics that deplete VEGF below the levels required for normal function. APX3330 is an oral tablet to be administered twice per day for the treatment of diabetic retinopathy (“DR”). A Phase 2 study in subjects with DR and an End-of-Phase 2 meeting have recently been completed, and a Special Protocol Assessment is planned to be submitted with the U.S. Food and Drug Administration (FDA). DR affects approximately 10 million people with diabetes and is projected to impact over 14 million Americans by 2050. DR is classified as Non-Proliferative Diabetic Retinopathy (“NPDR”), the early stage of the disease in which symptoms may be mild or non-existent or Proliferative Diabetic Retinopathy (“PDR”) which is the more advanced stage of diabetic eye disease that can be highly symptomatic with loss of vision. Approximately 80% of DR patients have NPDR that will progress to PDR if left untreated. Despite the risk for visual loss associated with this disease, over 90% of NPDR patients currently receive no course of treatment apart from observation by their eye care specialist until they develop sight-threatening complications. This is due to the treatment burden of the frequent eye injections required with currently approved therapies for this disease. APX3330 as an oral tablet has the potential to be an early, non-invasive treatment for the 8 million NPDR patients in the U.S. Treatment with APX3330 is expected to delay or prevent progression of NPDR, thereby reducing the need for expensive intravitreal injections with anti-VEGF therapies and reducing the likelihood of vision loss due to DR. Ocuphire has also in-licensed APX2009 and APX2014, which are second-generation analogs of APX3330. The unique dual mechanism of action of these Ref-1 inhibitors of reducing angiogenesis and inflammation could potentially be beneficial in treating other retinal diseases such as age-related macular degeneration, and geographic atrophy. Ocuphire is currently evaluating local delivery routes in addition to the systemic (oral) route as part of its pipeline expansion in retinal therapies. Ocuphire has a partnership with Viatris, Inc. to develop and commercialize phentolamine ophthalmic solution 0.75%. Phentolamine is a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size by uniquely blocking the alpha-1 receptors found on the iris dilator muscle without affecting the ciliary muscle. In September 2023, the FDA approved RYZUMVI™ (phentolamine ophthalmic solution 0.75%) to treat pharmacologically induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide). Phentolamine ophthalmic solution 0.75% is also in Phase 3 clinical development for the treatment of presbyopia and dim light (night) vision disturbances. For more information, visit www.ocuphire.com. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning the End-of-Phase 2 meeting with the FDA to confirm Phase 3 registration endpoints, study parameters for Phase 3 pivotal studies, Phase 3 development, FDA agreement on Special Protocol Assessment, the potential for APX330 to be the first non-invasive, early treatment to delay or prevent progression to vision-threatening complications, ability to fund operations into 2025, and the commercialization of RYZUMVI™. These forward-looking statements are based upon Ocuphire’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) the effects of COVID-19 on clinical programs and business operations, (ix) risks that the phentolamine ophthalmic solution partnership may not facilitate the commercialization or market acceptance of Ocuphire’s product candidates; (x) the success and timing of commercialization of any of Ocuphire’s product candidates and (xi) the maintenance of Ocuphire’s intellectual property rights. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and may be filed by Ocuphire from time to time with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contacts Corporate Investor Relations George Magrath M.D., M.B.A., M.S.CEOir@ocuphire.com Corey Davis, Ph.D. LifeSci Advisors cdavis@lifesciadvisors.com

Dr. Philip Ashman Appointed as President of International OperationsATLANTA, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians, and partners concerned with retinal health and maintaining better vision longer, today announced the appointment of Jason Werner, Chief Operating Officer (“COO”), effective October 2, 2023. In conjunction with this appointment, Dr. Philip Ashman, previously Alimera’s Chief Operating Officer and Senior Vice President, Commercial Operations Europe, was appointed President of International Operations. “Jason has been a strong voice and insightful influence on our board since joining earlier this year, and we are grateful to him for transitioning to this extremely important operational role,” said Rick Eiswirth, President and CEO of Alimera. “His extensive background in ophthalmics, along with his experience in previous roles in commercial development and corporate strategy, will be ideal in overseeing our manufacturing and regulatory efforts globally as we accelerate our growth trajectory.” Mr. Werner has served as a director of Alimera since Q2 2023. Prior to joining Alimera’s management team he has served as the Chief Executive Officer and Board Member of SightStream Biotherapeutics Inc, a biotechnology company focused on developing regenerative medicines in ophthalmics. Mr. Werner also currently serves on the board of directors of InflammX Therapeutics Inc, a privately held developer of novel treatments of the Inflammasome (NLRP3) Pathway based in San Diego, California. Mr. Werner previously co-founded and served as Chief Operating Officer of Eyevance Pharmaceuticals through its sale to Santen Pharmaceuticals Ltd. He has held a variety of commercial development roles and corporate strategy positions at companies such as Sun Pharma, Nicox SA and Inspire Pharmaceuticals, all within the field of ophthalmics. Mr. Werner received his B.S. in business administration from the University of New Hampshire. “Since joining Alimera’s Board of Directors earlier this year, I have had the privilege of working closely with this great team as we integrated the YUTIQ brand and completed a successful recapitalization of the balance sheet,” said Mr. Werner. “I strongly believe the recent acquisition of the YUTIQ brand along with the global growth of ILUVIEN will be transformational for Alimera and I am excited to be in a position to meaningfully contribute to the company’s continued growth in the retina space.” Mr. Eiswirth added, “I look forward to Alimera’s benefitting from Philip’s established expertise in commercial operations in his newly expanded role as we look to continue growing utilization of ILUVIEN across all of our international markets.” About Alimera Sciences, Inc. Alimera Sciences is a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. For more information, please visit www.alimerasciences.com. For investor inquiries:For media inquiries:Scott GordonJules Abrahamfor Alimera Sciencesfor Alimera Sciencesscottg@coreir.comjulesa@coreir.com Forward Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, Alimera’s expectations with respect to its business strategy, future operations, projected growth, and anticipated impact of the YUTIQ acquisition. Words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “contemplates,” “predict,” “project,” “target,” “likely,” “potential,” “continue,” “ongoing,” “will,” “would,” “should,” “could,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based on current expectations and involve inherent risks and uncertainties (some of which are beyond Alimera’s control), including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s most recently filed Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q, and any of Alimera’s subsequent filings with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely on the forward-looking statements Alimera makes or that are made on its behalf as predictions of future events. These forward-looking statements speak only as of the date of this press release. Alimera undertakes no obligation to publicly update or revise any of the forward-looking statements made in this press release, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/293f689b-268e-441c-b135-adb9d8fa9ba2