Xerophthalmia

Aldeyra has outlined a fast path back to the FDA’s door. \n The FDA has set back Aldeyra Therapeutics’ ambitions to win approval for its dry eye disease, rejecting its second application for approval and calling for data from at least one more study. But with a trial set to read out this quarter, the biotech is aiming to bounce back and resubmit its application in mid-2025.According to Aldeyra, the FDA found that the submission “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes.” The shortcoming led the FDA to ask for “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye,” the biotech said. Aldeyra first filed for FDA approval of reproxalap, a small molecule that binds reactive aldehyde species, in 2022. The company included data from two trials for ocular redness, a sign of dry eye disease, and from two dry eye disease symptom field trials. However, the FDA issued a complete response letter (CRL) and said at least one additional symptom trial was required.In response, Aldeyra kicked off three trials assessing dry eye disease symptoms: a dry eye chamber trial, a trial in a different dry eye chamber and a six-week field trial. The biotech filed for approval after the first dry eye chamber trial hit its primary endpoint. However, while Aldeyra’s second submission was bolstered by the chamber trial, the FDA found concerns “with the data from the trial submitted to the NDA that may have affected interpretation of the results,” the biotech said. The CRL raised “methodological issues, including a difference in baseline scores across treatment arms,” according to Aldeyra.Having initiated multiple studies in response to the first CRL, Aldeyra has outlined a fast path back to the FDA’s door. The biotech expects to meet with the agency within 30 days to discuss the CRL and to share top-line results from the ongoing dry eye disease field trial this quarter. Depending on the discussions and the data, Aldeyra could resubmit for approval in mid-2025 and anticipates a six-month FDA review. 

ZUG, Switzerland, March 11, 2025 (GLOBE NEWSWIRE) -- Successful 2024 marked by significant clinical advancements across Oculis’ late-stage and highly differentiated clinical pipeline targeting retina (OCS-01 in diabetic macular edema), neuro-ophthalmic (Privosegtor, OCS-05, in acute optic neuritis) and precision medicine (Licaminlimab, OCS-02, in dry eye disease) treatments Recent positive topline results in the ACUITY Phase 2 trial showed Privosegtor (OCS-05)’s neuroprotective benefits in anatomical preservation of the retina and visual function improvements in acute optic neuritis Oversubscribed $100 million equity financing completed to support the advancement of Oculis’ late-stage clinical portfolio Upcoming R&D Day planned on April 15, 2025, to showcase pipeline potential and company strategy Cash, cash equivalents and short-term investments of $109 million as of December 31, 2024, together with approximately $93 million net proceeds of recent financing provides cash runway into early 2028 Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis” or the “Company"), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced results for the quarter and full year ended December 31, 2024, and provided an overview of the Company’s progress. Riad Sherif M.D., Chief Executive Officer of Oculis: “We had a momentous year in 2024, and a strong start to 2025. We delivered two positive Phase 2 topline readouts from the ACUITY Privosegtor (OCS-05) trial in acute optic neuritis showing neuroprotective effects and the RELIEF trial of Licaminlimab (OCS-02) in dry eye disease (DED) with a precision medicine approach. In addition, we are on track to complete enrollment in the coming months for both Phase 3 DIAMOND trials of OCS-01 in diabetic macular edema (DME). The recent $100 million equity financing is another significant milestone for Oculis to propel its pipeline. As we continue to execute on our vision to be a leader in ophthalmic and neuro-ophthalmic fields and to bring innovative sight-saving treatments to market, 2025 will be a year in which we remain focused on execution to advance our late-stage clinical portfolio. We look forward to sharing updates on our portfolio strategy at our upcoming R&D Day.” Q4 2024 and Recent Highlights Clinical Highlights and Upcoming Milestones: OCS-01: On-track to complete enrollment in Phase 3 DIAMOND program in DME with top-line data readout expected in first half of 2026. NDA submission readiness for post-ocular surgery also on track in Q1 2025. Privosegtor (OCS-05): Positive topline results from the Phase 2 ACUITY trial in patients with acute optic neuritis where Privosegtor (OCS-05) achieved primary endpoint of safety and three secondary efficacy endpoints demonstrating improvement for Privosegtor (OCS-05) compared to placebo in objective structural measures of retinal thickness and functional vision improvement. FDA interactions are planned for the second half of 2025 to discuss the ACUITY trial results and align on the next steps, including a registrational development program for acute optic neuritis. Licaminlimab (OCS-02): Positive readout from the Phase 2b RELIEF trial in signs of DED and FDA interaction conducted in Q1 2025 confirmed development path forward with a precision medicine approach. On-track to complete enrollment in Phase 3 DIAMOND program in DME with top-line data readout expected in first half of 2026. NDA submission readiness for post-ocular surgery also on track in Q1 2025. Positive topline results from the Phase 2 ACUITY trial in patients with acute optic neuritis where Privosegtor (OCS-05) achieved primary endpoint of safety and three secondary efficacy endpoints demonstrating improvement for Privosegtor (OCS-05) compared to placebo in objective structural measures of retinal thickness and functional vision improvement. FDA interactions are planned for the second half of 2025 to discuss the ACUITY trial results and align on the next steps, including a registrational development program for acute optic neuritis. Positive readout from the Phase 2b RELIEF trial in signs of DED and FDA interaction conducted in Q1 2025 confirmed development path forward with a precision medicine approach. Further business and pipeline development updates to be provided during the R&D Day on April 15, 2025 in New York City. Q4 and Full Year 2024 Financial Highlights Cash position: As of December 31, 2024, the Company had total cash, cash equivalents and short-term investments of CHF 98.7 million or $109.0 million, compared to CHF 91.7 million or $108.9 million as of December 31, 2023. The increase in cash position from December 31, 2023 reflects the proceeds from the registered direct offering in the second quarter of 2024. Based on its cash, cash equivalents and short-term investments at December 31, 2024 and approximately $93 million in net proceeds received from the recent financing, and its development plans, the Company’s cash balances are expected to fund operations into early 2028. Research and development expenses were CHF 11.8 million or $13.4 million for the three-months ended December 31, 2024, compared to CHF 8.0 million or $9.0 million in the same period in 2023. Research and development expenses for the year ended December 31, 2024 were CHF 52.1 million or $59.1 million, compared to CHF 29.2 million or $32.6 million in the previous year. The increase was primarily due to clinical development expenses for the active clinical trials for OCS-01 in DME, Privosegtor (OCS-05) in acute optic neuritis and Licaminlimab (OCS-02) in DED. General and administrative expenses were CHF 5.5 million or $6.3 million for the three-months ended December 31, 2024, compared to CHF 4.3 million or $4.9 million in the same period in 2023. General and administrative expenses for the year ended December 31, 2024 were CHF 21.8 million or $24.8 million, compared to CHF 17.5 million or $19.5 million in the previous year. The increase was primarily due to share-based compensation expenses. Q4 net loss was CHF 28.7 million or $32.6 million for the fourth quarter ended December 31, 2024, compared to CHF 12.5 million or $14.1 million for the same period in 2023. The increase was primarily driven by changes in the fair value (non-cash) of outstanding warrants, increased clinical development costs and increased share-based compensation expenses. FY2024 net loss was CHF 85.8 million or $97.4 million for the year ended December 31, 2024, compared to CHF 88.8 million or $98.8 million for the same period in 2023. The decrease was primarily due to a non-recurring and non-cash merger and listing expense recorded in 2023 of CHF 34.9 million or $38.2 million, partially offset by changes in the fair value of outstanding warrants, increases in clinical development costs and expenses incurred to operate as a dual-listed public company. FY2024 non-IFRS net loss was CHF 85.8 million or $97.4 million, or CHF 2.12 or $2.41 per share, for the year ended December 31, 2024, compared to CHF 49.0 million or $54.5 million, or CHF 1.64 or $1.83 per share, for the same period in 2023. The increase in non-IFRS net loss was primarily driven by changes in the fair value of outstanding warrants and the advancement of clinical development programs during the year, including the Phase 3 DIAMOND-1 and DIAMOND-2 trials for DME, Phase 2 ACUITY trial for acute optic neuritis, and Phase 2 RELIEF trial for DED. Non-IFRS Financial Information This press release contains financial measures that do not comply with International Financial Reporting Standards (IFRS) including non-IFRS loss, and non-IFRS loss attributable to equity holders per common share. These non-IFRS financial measures exclude the impact of items that the Company’s management believes affect comparability or underlying business trends. These measures supplement the Company’s financial results prepared in accordance with IFRS. The Company’s management uses these measures to better analyze its financial results and better estimate its financial outlook. In management’s opinion, these non-IFRS measures are useful to investors and other users of the Company's financial statements by providing greater transparency into the ongoing operating performance of the Company and its future outlook. Such measures should not be deemed to be an alternative to IFRS requirements. The non-IFRS measures for the reported periods reflect adjustments made to exclude: Merger and listing expense, which was a one-time and non-cash expense of CHF 34.9 million or $38.2 million in the year-to-date 2023 total operating expenses. During the third quarter of 2023, the Company gave effect to the dissolution of its Merger Sub 2 entity pursuant to the Business Combination Agreement with EBAC. As a result, the cumulative translation adjustments related to Merger Sub 2 previously reported in equity and recognized in other comprehensive loss, were reclassified from equity to the Condensed Consolidated Interim Statement of Loss for the year ended December 31, 2023. The resulting non-cash foreign exchange impact of such reclassification amounted to CHF 5.0 million or $5.7 million for the year ended December 31, 2023. Consolidated Statements of Financial Position Consolidated Statements of Loss Reconciliation of Non-IFRS Measures (Unaudited) -ENDS- About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS / XICE: OCS) purposefully driven to save sight and improve eye care. Oculis’ highly differentiated pipeline of multiple innovative product candidates in clinical development includes: OCS-01, a topical eye drop candidate for diabetic macular edema (DME); Privosegtor (OCS-05), a neuroprotective candidate for acute optic neuritis with potentially broad clinical applications in other neuro-ophthalmic diseases; and Licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis 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 AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, the timing, progress and results of current and future clinical trials, including the Company’s Phase 3 DIAMOND program in DME, Oculis’ research and development programs, regulatory and business strategy, future development plans; the timing or likelihood of regulatory filings and approvals; and the Company’s expected cash runway 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 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. Attachments Oculis 2024 Consolidated IFRS Financial Statements Oculis 2024 MD&A Oculis Q4 2024 - Press Release Oculis ESEF reporting

DUBLIN--( BUSINESS WIRE )--The "Dry Eye Disease - Epidemiology Forecast - 2034" report has been added to ResearchAndMarkets.com's offering. The report delivers an in-depth understanding of Dry Eye Disease (DED), historical and forecasted epidemiology of Dry Eye Disease (DED) in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. For the purpose of designing the patient-based model for the Dry Eye Disease (DED) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Total Diagnosed Prevalent Cases of DED, Gender-specific Diagnosed Prevalent Cases of DED, Age-specific Diagnosed Prevalent Cases of DED, and Severity-specific Diagnosed Prevalent Cases of DED in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034. In the assessment done, the estimated total diagnosed prevalent cases of DED in the 7MM were nearly 54.69 million in 2023. Among the European countries, the United Kingdom had the highest diagnosed prevalent cases of DED with ~6,112 thousand cases, followed by Germany, which had diagnosed prevalent population of ~5,004 thousand in 2023. On the other hand, Spain had the lowest prevalent population (2,064 thousand cases). The US reported the highest number of total diagnosed prevalent cases of DED among the 7MM countries with 41% whereas Japan reported the least cases (19%). This trend is anticipated to be followed during the forecast period as well. In the US, gender-specific diagnosed prevalent cases of DED revealed ~9,439 thousand cases among males and approximately ~13,035 thousand cases among females. Projections indicate that by 2034, the prevalence among females will surpass that of males. The analysis shows that the UK reported the highest number of DED cases in individuals aged 50 and older, with ~4,889 thousand cases. This was followed by ~691 thousand cases in the 40-49 age group and ~532 thousand cases in the 18-39 age group. Projections indicate that the UK is expected to continue leading in these figures by 2034. KOL Views To gaze into the epidemiology insights of the real world, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research on disease prevalence. The analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Harvard Medical School, Boston, Massachusetts, US University of Pikeville, Kentucky College of Optometry, Pikeville, Kentucky, US; Magdeburg-Stendal University of Applied Sciences, Stendal, Sachsen-Anhalt, Germany; Department of Ophthalmology, Dijon University Hospital, Dijon, France; University of Milan, Milan, Italy; Optometry and Vision Science, Aston University, Birmingham, UK and Ryogoku Eye Clinic, Tokyo, Japan, and others were contacted. Their opinion helps understand and validate current disease prevalence, gender involved with the disease, diagnosis rate, and diagnostic criteria. Key Highlights In 2023, the total diagnosed prevalence of Dry eye disease (DED) was highest in the US among the 7MM, accounting for nearly 22.47 million cases which is further expected to increase by 2034. In Japan, in 2023, ~2,341 thousand males and ~ 8.29 million females were affected with Dry eye disease (DED). estimates that these numbers might increase by 2034. In 2023, the UK reported ~2,811 thousand mild, ~1,345 thousand moderate, and ~1,956 thousand severe cases of DED. Analysis by experts indicates that the overall severity-specific cases of DED are expected to rise in the coming years. The Dry Eye Disease (DED) cases are expanding due to increasing prevalence, rising awareness and better diagnostic capabilities, which increase demand for treatments. Advancements in research, increased funding for rare diseases, and the development of novel therapies are also key drivers. As per estimates, Japan accounted for nearly 19% of the Total Diagnosed Prevalent Cases of Dry Eye Disease (DED) in the 7MM in 2023. Scope of the Report The report covers a segment of key events, an executive summary, descriptive overview of Dry Eye Disease (DED), explaining its causes, signs and symptoms, and currently available diagnostic algorithms and guidelines. Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and diagnosis guidelines. The report provides an edge for understanding trends, expert insights/KOL views, and patient journeys in the 7MM. A detailed review of current challenges in establishing the diagnosis. Dry Eye Disease (DED) Report Insights Patient Population Country-wise Epidemiology Distribution Total Diagnosed Prevalent Cases of DED Gender-specific Diagnosed Prevalent Cases of DED Age-specific Diagnosed Prevalent Cases of DED Severity-specific Diagnosed Prevalent Cases of DED Dry Eye Disease (DED) Report Key Strengths 11 years Forecast The 7MM Coverage Dry Eye Disease (DED) Epidemiology Segmentation Key Topics Covered: 1. Key Insights 2. Report Introduction 3. Dry Eye Disease (DED) Epidemiology Overview at a Glance 3.1. Patient Share Distribution of DED in 2020 3.2. Patient Share Distribution of DED in 2034 4. Epidemiology Methodology of DED 5. Executive Summary of Dry Eye Disease (DED) 6. Key Events 7. Disease Background and Overview 7.1. Introduction 7.2. Tear Film Working 7.3. Etiology 7.4. Risk Factors 7.5. Pathophysiology 7.6. Symptoms and Clinical Presentations 7.7. Diagnosis 7.7.1. Diagnostic Criteria 7.7.1.1. Comparison of Dry Eye Definition and Diagnostic Criteria between JDES/ADES and DEWS II 7.7.1.2. Diagnostic Criteria of the JDES, 1995 Version 7.7.1.3. Diagnostic criteria of DED proposed by the JDES (2006 version) 7.7.2. Differential Diagnosis 7.7.3. Diagnostic Algorithm 7.7.4. Diagnostic Scheme 7.7.5. Diagnostic Guidelines 7.7.5.1. Dry Eye Syndrome Preferred Practice Pattern guidelines by American Academy of Ophthalmology 8. Epidemiology and Patient Population 8.1. Key Findings 8.2. Assumptions and Rationale: The 7MM 8.2.1. Diagnosed Prevalence of DED 8.2.2. Gender-specific Prevalence of DED 8.2.3. Age-specific Diagnosed Prevalence of DED 8.2.4. Severity-specific Diagnosed Prevalence of DED 8.3. Total Diagnosed Prevalent Cases of DED in the 7MM 8.4. The United States 8.5. EU4 and the UK 8.5.1. Germany 8.5.2. France 8.5.3. Italy 8.5.4. Spain 8.5.5. The United Kingdom 8.6. Japan 9. Patient Journey 10. KOL Views 11. Appendix For more information about this report visit https://www.researchandmarkets.com/r/vegs1w About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.