Virginia Eye Consultants, Inc.

Data Demonstrates Sustained Safety and Efficacy in Treating Signs and Symptoms of Dry Eye Disease NASHVILLE, Tenn.--(BUSINESS WIRE)-- Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, is pleased to announce results from its ESSENCE‑2 open-label extension (OLE) clinical study for VEVYE® (cyclosporine ophthalmic solution) 0.1%, the first and only cyclosporine to treat the signs and symptoms of dry eye disease (DED). ESSENCE-2 OLE was a Phase 3, prospective, multicenter, open-label, clinical study with 202 patients, who had previously completed the ESSENCE‑2 study, receiving VEVYE in each eye twice a day for 52 weeks. The one-year study results, published in Cornea, demonstrated VEVYE’s sustained safety and efficacy in treating the signs and symptoms of DED, underscoring its value in managing this chronic condition. Key findings include: Statistically significant improvements in all prespecified efficacy endpoints compared with baseline at each visit. Corneal staining improvements were early and stabilized over time while tear production improved continuously and symptomatology improvement followed these effects. The most common ocular treatment-related adverse events were mild instillation site pain in 13 patients (6.5%) and reduced visual acuity in 6 patients (3.0%). One patient withdrew during the 52-week study due to an ocular adverse event (mild burning/stinging). On a 0 to 10 scale (the higher the number equating to a better rating), when patients were asked to rate the question, “How satisfied are you with the study eye drop?”— 33.1% of patients provided the highest possible rating of 10. Approximately 91% of patients rated a score of 5 or higher, indicating satisfaction with the treatment. Investigators conclude that water-free cyclosporine 0.1% ophthalmic solution was safe and well tolerated during long-term use. Dr. John D. Sheppard, Ophthalmologist, President of Virginia Eye Consultants, and one of the investigators on the ESSENCE‑2 OLE study, stated, “Topical cyclosporine has established a remarkable decades-long efficacy and safety profile. Finally, we have the right vehicle.” Dr. Laura M. Periman, Ophthalmologist and Director of Dry Eye Services and Clinical Research at Periman Eye Institute, added, “We know that tolerability is a major issue with long-term immunomodulatory medications leading to poor patient compliance and dropout. In this 52-week study, perhaps the most impressive data point was that only one patient stopped using VEVYE because of an ocular adverse event, which was mild burning and stinging. Also, patients randomized to VEVYE in ESSENCE-2 that continued into the OLE, on average, saw their natural tear production nearly double after 56 weeks of treatment from baseline. Furthermore, these patients saw a statistically significant improvement in all measured symptoms at all measured time points compared to baseline. ESSENCE-2 OLE data demonstrates the long-term potential of VEVYE for patients suffering from chronic dry eye disease.” Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “The OLE data affirms why VEVYE is such a special product and why so many patients are now entering their sixth refill cycle. VEVYE’s unique value is enabled because of its patented water-free formulation, which catalyzes additional product features and related clinical benefits1: VEVYE is preservative-free, has no pH or osmolarity, and requires only twice‑daily dosing with an individual dosage that is 1/10th the size of conventional eye drops. In addition, in a pre-clinical ex-vivo corneal penetration study2, VEVYE’s semi-fluorinated alkane vehicle, perfluorobutylpentane (PFBP), delivered approximately 22 times more cyclosporine into the cornea compared to RESTASIS®. This OLE data supports our efforts to make sure eyecare professionals and their patients are aware of how VEVYE helps manage dry eye disease by improving – over the longer term – the signs and symptoms of this chronic disease.” For more information about VEVYE, please visit vevye.com. About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the North American market. Harrow helps eyecare professionals preserve the gift of sight by making its portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of patients each year. For more information about Harrow, please visit harrow.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's website at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. About VEVYE® (cyclosporine ophthalmic solution) 0.1% VEVYE (cyclosporine ophthalmic solution) 0.1%, non-preserved, for topical ophthalmic use. Approved by the U.S. Food and Drug Administration (FDA) in June 2023, VEVYE combines a semifluorinated alkane eyedrop technology (perfluorobutylpentane) with cyclosporine 0.1% in solution. VEVYE is indicated to treat both the signs and symptoms of DED. Clinical trials for VEVYE have demonstrated that it not only increases tear production, but it also has been shown to improve the cornea surface as evidenced by total corneal fluorescein staining (tCFS). Clinical trials also show that VEVYE’s clinical benefits begin as early as 15 days and show sustained improvement over 12 months – all while maintaining an excellent patient tolerability and low adverse event profile. INDICATIONS AND USAGE VEVYE is indicated for the treatment of the signs and symptoms of dry eye disease. CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Potential for Eye Injury and Contamination. To avoid the potential for eye injury and/or contamination, patients should not touch the bottle tip to the eye or other surfaces. Use with Contact Lenses. VEVYE should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of VEVYE ophthalmic solution. ADVERSE REACTIONS Clinical Trials Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials with 738 subjects receiving at least 1 dose of VEVYE, the most common adverse reactions were instillation site reactions (8%) and temporary decreases in visual acuity (3%). USE IN SPECIAL POPULATIONS Pregnancy. There are no adequate and well-controlled studies of VEVYE administration in pregnant women to inform a drug-associated risk. Lactation. Caution should be exercised when VEVYE is administered to a nursing woman. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. For additional information about VEVYE, please see the Full Prescribing Information. __________________________________ 1 VEVYE (cyclosporine ophthalmic solution) 0.1% (package insert). Harrow IP, LLC: 2023. 2 Data on file. RESTASIS is not a Harrow-owned brand, and the RESTASIS trademark is the property of its respective owner.

SEATTLE, CAMBRIDGE, Mass. & TOKYO--(BUSINESS WIRE)-- Aurion Biotech, whose mission is to restore vision to millions of patients with life-changing regenerative therapies, today announced several presentations during the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting to be held April 5-8, 2024 in Boston, Massachusetts. At Eyecelerator and ASCRS 2024, data will be presented from the Company’s Escalón and IOTA studies, which treated subjects with its combination cell therapy product (biologic/drug) comprised of neltependocel (allogeneic human corneal endothelial cells [CECs]) and Y-27632 (an inhibitor of Rho-associated, coiled-coil containing protein kinase [ROCK]). “We are delighted to share additional insights into these clinical studies, in multiple sessions at the Eyecelerator and ASCRS 2024 meetings,” said Michael Goldstein, M.D., president and chief medical officer, Aurion Biotech. “We believe these presentations will be of significant interest to the ophthalmology community, as they highlight the exciting potential of our cell therapy to treat patients with corneal endothelial disease.” The schedule of presentations includes: Corneal Endothelial Cell Therapy for Corneal Endothelial Disease Thursday, April 4, 2024 1:00 p.m. EST Eyecelerator, Omni Boston Hotel at the Seaport, Level 2 Marquis room Presenter: Greg Kunst, Chief Executive Officer, Aurion Biotech Comparison of Subjects with Corneal Edema Receiving Corneal Endothelial Cells with ROCK Inhibitor in One Eye vs. Cells Alone in the Fellow Eye Sunday, April 7, 2024 2:00 p.m. EST ASCRS Boston Convention & Exhibition Center (BCEC) - Level 2 Presenters: Michael Goldstein, M.D., President & Chief Medical Officer, Aurion Biotech; Nysha Blender, O.D., Senior Director Medical Affairs, Aurion Biotech Human Corneal Endothelial Cell Transplantation Combined with Cataract Extraction and PCIOL in Subject with Corneal Edema Monday, April 8, 2024 8:45 a.m. EST ASCRS Boston Convention & Exhibition Center (BCEC) - Meeting Level 2, Room 259A Presenter: Elizabeth Yeu, M.D., President, ASCRS; Virginia Eye Consultants Aurion Biotech recently opened a Phase 1 / 2 clinical trial (ABA-1 / CLARA), a prospective, multi-center, randomized, double-masked, parallel-arm cell dose-ranging study in subjects with corneal edema secondary to corneal endothelial dysfunction. The study will evaluate three different doses of neltependocel used in combination with Y-27632. Approximately 100 subjects will be randomized in sites in the U.S. and in Canada. The ABA-1 / CLARA trial is designed to assess the safety, tolerability, and efficacy of AURN001 for the treatment of corneal edema secondary to corneal endothelial dysfunction. The primary endpoint is the percentage of subjects who gain 3 lines of vision at 6 months. Aurion Biotech’s combination cell therapy recently received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), for the treatment of bullous keratopathy, marking the first-ever regulatory approval in the world for an allogeneic cell therapy to treat corneal endothelial disease. About Aurion Biotech With offices in Seattle, Cambridge and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company’s first candidate is for the treatment of corneal edema secondary to corneal endothelial disease, and is the first off-the-shelf, clinically validated cell therapy for corneal care, having received regulatory approval in Japan. The Company has initiated clinical trials in the U.S. and Canada. Privately held, Aurion Biotech is backed by leading investors that include Deerfield, Alcon, Petrichor, Flying L Partners, Falcon Vision / KKR, and Visionary Ventures. To learn more about Aurion Biotech, visit .

Completed enrollment in Phase 2b RELIEF trial of Licaminlimab (OCS-02), anti-TNF (tumor necrosis factor) alpha eye drops in Dry Eye Disease (DED); topline results expected in Q2 2024Second Phase 3 trial (DIAMOND-2) of OCS-01 eye drops in Diabetic Macular Edema (DME) initiated as planned, in addition to the ongoing DIAMOND-1 Phase 3 trial initiated in late 2023World-renowned retina specialists, Professor Ramin Tadayoni, M.D., Ph.D. appointed as Chief Scientific Officer and Arshad M. Khanani, M.D., M.A., FASRS appointed as Chair of Oculis’ Retina Scientific Advisory Board (SAB)Seasoned HR executive, Virginia R. Dean, appointed as Chief Human Resources Officer in Boston ZUG, Switzerland, and BOSTON, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today provides updates at its in-person and virtual R&D Day on continued progress in advancing its late-stage clinical trials and strengthening the organization with additional senior appointments to its management and advisory teams. In-person and virtual R&D Day today from 9:00 AM to 11:00 AM EST at the InterContinental New York Barclay. For registration, click here. “2024 promises to be another exciting year for Oculis as we advance our late-stage clinical development programs. We have met two important clinical milestones with the rapid completion of enrollment in the Phase 2b RELIEF trial of OCS-02 in Dry Eye Disease (DED) and the initiation of the second Phase 3 trial of OCS-01 in Diabetic Macular Edema (DME). Additionally, I am very pleased to welcome Ramin and Virginia to the executive team and to continue to work with Arshad, new Chair of the Oculis’ Retina SAB, as we continue to advance our clinical programs and start to prepare for our first potential launch in the U.S. I am certain that the extensive experience each of them brings will be invaluable to Oculis,” said Riad Sherif, M.D., Chief Executive Officer of Oculis. “We look forward to driving this positive momentum in clinical execution of both DIAMOND Phase 3 trials, and in the delivery of clinical milestones this year, including topline results for the Phase 2b RELIEF trial of OCS-02 in DED in Q2 2024.” Completion of Enrollment in Phase 2b RELIEF trial with Licaminlimab (OCS-02) in DED The Phase 2b RELIEF study evaluating topical anti-TNFα Licaminlimab (OCS-02) in DED was initiated in late 2023 and enrollment of 120 patients was rapidly completed. DED is a common condition estimated to impact nearly 40 million people in 2023 in the U.S. alone. Elizabeth Yeu, M.D., Eastern Virginia Medical School, Virginia Eye Consultants, and President of ASCRS commented: “With its dual anti-inflammatory and anti-necrotic mechanisms of action, Licaminlimab eye drops have shown promising results in previous trials including: a significant reduction of ocular discomfort in DED, a rapid onset of action, and a good tolerability profile. Based on how the broader class of systemic TNFα inhibitors have dramatically improved the management of multiple inflammatory diseases in other therapeutic areas, I am eagerly awaiting the completion of the RELIEF trial to learn more about the potential of Licaminlimab eye drops to address the unmet needs of the millions of patients living with DED.” Initiation of OCS-01 Phase 3 DIAMOND-2 Trial in DME The first patient first visit was completed in the second 52-week Phase 3 DIAMOND-2 trial evaluating OCS-01 eye drops for the treatment of DME, a leading cause of vision impairment in working-age adults. In Stage 1 of the DIAMOND program, OCS-01 demonstrated robust statistically significant improvement in vision and reduction in retinal edema vs. vehicle, and was well-tolerated with no unexpected safety findings. The visual acuity improvement observed with OCS-01 at 12-week was similar to approved injectables at the same time point. More information about the Stage 1 results can be found here. Oculis Strengthens its Executive and Scientific Advisory Teams Oculis also announced today key executive appointments to bolster its leadership and scientific advisory teams. World-renowned retina specialists, Professor Ramin Tadayoni, M.D., Ph.D. was appointed to the role of Chief Scientific Officer (CSO), and Arshad M. Khanani, M.D., M.A., FASRS, was appointed as Chair of Oculis’ Retina Scientific Advisory Board. In addition, Virginia R. Dean, a seasoned human resources executive with significant experience in growing life science companies, was appointed to the role of Chief Human Resources Officer. Dr. Tadayoni, Dr. Khanani and Ms. Dean will play key strategic roles as the Company continues to advance its diversified late-stage pipeline and expands its footprint in the U.S. while it prepares for the potential first commercial launch. Joanne Chang, M.D., Ph.D., has decided to leave the organization for personal reasons and will continue to collaborate with Oculis on special projects. Ramin Tadayoni, M.D., Ph.D., is a highly distinguished and accomplished retina specialist. He is the current President of EURETINA, the European Society of Retina Specialists and the Retina Department Chairman of Rothschild Foundation Hospital, including the French Myopia Institute. Dr. Tadayoni has been a Principal Investigator in numerous trials and served as an advisor for companies in the ophthalmology space for over two decades on topics spanning across medical, regulatory and market access, including his role as Co-Chair of the Oculis Scientific Advisory Board. Prior to joining Oculis as Chief Scientific Officer, Dr. Tadayoni was a Professor of Ophthalmology at Université Paris Cité, and the Department Chairman at Lariboisière and Saint Louis hospitals in Paris, France. As a passionate physician and researcher, he has authored more than 140 medical and scientific articles and has made numerous contributions to ophthalmology textbooks and is part of several international diseases’ classifications groups. He has also received numerous awards of distinction including the American Academy of Ophthalmology Achievement Award and the prestigious Jules Gonin Award from the Retina Research Foundation. Dr. Tadayoni received his medical degree and completed his internship at Paris V University. His retina fellowship was completed at Lariboisière University Hospital while simultaneously pursuing his Ph.D. in Science at Paris VII University and the Paris Vision Institute. He received his undergraduate training in medicine at the University of Marseille. “After being part of Oculis’ journey for the past few years, as Co-Chair of the Scientific Advisory Board, I am thrilled to join the Oculis executive team. As a member of the DIAMOND program Steering Committee and a practicing retina specialist, it has been very exciting to see the positive results in DME with OCS-01 and progress made to date with the initiation of two 52-week Phase 3 trials in DME,” said Ramin Tadayoni, M.D., Ph.D., Chief Scientific Officer of Oculis. “I look forward to contributing to the efforts of this outstanding team to further drive Oculis’ innovative and diversified pipeline, which has the potential to change the treatment paradigm in ophthalmology across multiple indications.” Arshad M. Khanani, M.D., M.A., FASRS is a world-renowned retina specialist and clinical scientist. He founded the clinical research section at Sierra Eye Associates, and currently serves as its Managing Partner, Director of Clinical Research, and Director of Fellowship. He has been a principal investigator for more than 120 clinical trials and has authored over 100 scientific publications. Additionally, he is a Clinical Associate Professor at the University of Nevada, Reno School of Medicine. Dr. Khanani is an elected member of the Retina Society, Macula Society and has received numerous awards of distinction. 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. Virginia R. Dean is a seasoned human resources (HR) leader with over 25 years of experience as a senior HR executive in both start-ups and well-established biopharmaceutical companies. She brings a breadth of experience in scaling up life science companies at various stages of growth, from pre-clinical to fully commercialized. Prior to joining Oculis, she was the Chief People Officer and Senior Vice President at Axcella Therapeutics where she led a rapid transformation of the organization. Over the course of her career, she has scaled five organizations, private and public, and participated in four acquisitions. Ms. Dean received her M.B.A. from Simmons University and holds a B.A. in anthropology from the University of Vermont. She will be based in Oculis’ office in Boston, Massachusetts. About Phase 2b RELIEF Trial of OCS-02 In Dry Eye Disease The Phase 2b RELIEF trial is a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the safety and efficacy of Licaminlimab for the treatment of moderate-to-severe DED (NCT05896670). The trial was designed based upon the positive findings from multiple previous studies in DED demonstrating significantly reduced ocular discomfort with a greater percentage of high responders vs. vehicle and was well tolerated with no unexpected adverse events reported. The 120 enrolled patients have been randomized to either Licaminlimab or vehicle for a 6-week treatment period and a 2-week follow up. The trial also contains an analysis for a subset of patients with a genetic variant that demonstrated an improved treatment response in the previous Phase 2a trial. RELIEF topline results are anticipated in Q2 2024. About Phase 3 DIAMOND Program of OCS-01 in Diabetic Macular Edema The DIAMOND-1 (DIAbetic Macular edema patients ON a Drop) and DIAMOND-2 trials are Phase 3, double-masked, randomized, multi-center trials which will evaluate the efficacy and safety of OCS-01 eye drops in patients with DME. Oculis aims to enroll 350-400 patients in each of these pivotal trials that will be randomized 1:1 to receive OCS-01 or vehicle six times daily for the 6-week induction phase and then three times daily through week 52 for the maintenance phase. The primary endpoint is change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52. Secondary endpoints include percentage of patients with ≥15-letter gain in BCVA and change in central subfield thickness (CST), both at Week 52. Both trials were initiated upon the positive findings from stage 1 of the DIAMOND program, which was announced in the second quarter of 2023. About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS) purposefully driven to save sight and improve eye care. Oculis’ highly differentiated pipeline comprises multiple innovative product candidates in development. It includes OCS-01, a topical eye drop candidate for diabetic macular edema (DME) and for the treatment of inflammation and pain following cataract surgery; OCS-02, a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis; and OCS-05, a disease modifying candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. Headquartered in Switzerland and with operations in the U.S., Oculis’ goal is to deliver life-changing treatments to patients worldwide. The company is led by an experienced management team with a successful track record and is supported by leading international healthcare investors. For more information, please visit: www.oculis.com Oculis Contacts Ms. Sylvia Cheung, CFOsylvia.cheung@oculis.com Investor & Media Relations LifeSci Advisors Corey Davis, Ph.D. cdavis@lifesciadvisors.com 1-212-915-2577 Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential of Oculis’ innovative and diversified pipeline to change the treatment paradigm in ophthalmology across multiple indications; the potential benefits of OCS-01 and OCS-02, including patient impact and market opportunity; the potential of OCS-01 for the treatment of DME; the potential of Licaminlimab or OCS-02 eye drops to address the unmet needs of the millions of patients living with DED; expected future milestones and catalysts; the initiation, timing, progress and results of Oculis’ clinical trials, including the timing of topline results for the Phase 2b RELIEF trial; Oculis’ research and development programs, regulatory, commercial and business strategy, future development plans, and management; and Oculis’ ability to advance product candidates into, and successfully complete, clinical trials; the potential benefits of Oculis’ senior management and advisory additions; and Oculis’ potential first commercial launch in the U.S., are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.