공시 • Apr 14

Ocular Therapeutix Inc Announces Additional Positive Week 52 Data from Landmark SOL-1 Phase 3 Trial of AXPAXLI in Wet AMD

Ocular Therapeutix, Inc. announced additional positive Week 52 data from the SOL-1 Phase 3 superiority trial of AXPAXLI (also known as OTX-TKI), its investigational product candidate for the treatment of wet age-related macular degeneration (wet AMD). The additional post-hoc analyses, presented at the 14th Annual Vit-Buckle Society (VBS) Meeting, reinforce the superior durability, strong sustained disease control, and generally well-tolerated safety seen with AXPAXLI in SOL-1. Highlights from the data presented at VBS include: Strong overall efficacy profile with unmatched durability: Achieved statistical significance in the first three of five key secondary endpoints tested in hierarchical order. In addition, six other pre-specified secondary endpoints measuring clinically significant functional and anatomic outcomes were met with statistical significance. Sustained disease control (post-hoc analysis): Subjects in the AXPAXLI arm had significantly lower risk in anatomic worsening from Week 8 compared to the aflibercept (2 mg) arm. Week 8 was chosen to give both arms adequate time from the last aflibercept (2 mg) injection and start at a similar reference timepoint. The median time to =30 uM Central Subfield Thickness (CSFT) increase from Week 8 was 39 weeks in the AXPAXLI group and 16 weeks in the aflibercept (2 mg) group, a 23-week difference. An estimated hazard ratio of 0.7 indicates that, at any time from Week 8 to Week 52, subjects in the treatment group experienced a 30% lower risk of the event (descriptive p=0.0028) compared with the control group. The median time to =75 uM CSFT increase from Week 8 was 46 weeks in the AXPAXLI group and 24 weeks in the aflibercept (2 mg) group, a 22-week difference. An estimated hazard ratio of 0.5 indicates that, at any time from Week 8 to Week 52, subjects in the treatment group experienced a 50% lower risk of the event (descriptive p. In all AXPAXLI subjects who had a vitreous floater AE, drug particles are no longer visible (mean time of 20 weeks). Subjects treated with AXPAXLI generally maintained loading phase visual acuity gains up to Week 52 across quartile subgroups based on BCVA at screening. Ocular Therapeutix remains on track to submit its New Drug Application (NDA) for AXPAXLI in wet AMD based on the SOL-1 trial alone, subject to planned formal discussions with U.S. FDA. This planned submission is consistent with recent FDA commentary, including a February 2026 New England Journal of Medicine editorial indicating that a single well-controlled Phase 3 trial is expected to become the new default standard for approval. In early-April, 2026, the FDA Commissioner further noted that this framework is anticipated to be phased in over the next six months, highlighting that the same statistical power can be achieved with a well-designed, well controlled, appropriately powered, single pivotal trial. These recent comments further reinforce the Company’s confidence in NDA acceptability based on SOL-1 alone, aligning with its goal of bringing AXPAXLI to patients as quickly as possible. AXPAXLI (also known as OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD and diabetic retinal disease. The registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center, double-masked, randomized (1:1), parallel group trial that involves more than 100 clinical trial sites located in the U.S. and Argentina. In December 2024, the trial completed randomization of 344 treatment-naïve subjects with a diagnosis of wet AMD in the study eye. Two randomized subjects withdrew from the trial prior to receiving Day 1 treatment. The superiority trial has an eight-week loading segment prior to randomization. During the loading segment, subjects who have 20/80 vision or better and a central subfield thickness (CSFT) of =500 µm receive two doses of aflibercept (2 mg) at Week -8 and Week -4. Subjects who achieve best corrected visual acuity (BCVA) of 20/20 at Day 1 (baseline) or gain at least 10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at Day 1 along with a CSFT of =350 µm were then randomized to receive a single dose of AXPAXLI (0.45 mg) or a single dose of aflibercept (2 mg). At Week 52 and at Week 76, all subjects are re-dosed with their respective initial treatment of AXPAXLI (0.45 mg) or aflibercept (2 mg). Subjects will be followed for safety until the end of Week 104. Throughout the trial, subjects are assessed monthly. Trial subjects and designated trial personnel will remain masked through the end of Week 104. The clinical trial protocol requires that, during the trial, subjects in either arm meeting the pre-specified rescue criteria, which includes a BCVA loss of =15 ETDRS letters from baseline or new vision-threatening macular hemorrhage, will receive a supplemental dose of aflibercept (2 mg). The protocol provides that after the first rescue injection, rescue therapy may be provided at investigator discretion per their clinical judgement. The primary endpoint of SOL-1 is the proportion of subjects who maintain visual acuity, a loss of <15 ETDRS letters of BCVA from baseline, at Week 36. Predefined statistical rules were applied to adjust for treatment discontinuation or deviation as per the pre-specified statistical analysis plan. The trial remained masked following Week 36 and subjects were evaluated for treatment durability at Week 52. The trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. In February 2026, Ocular reported positive SOL-1 Week 52 topline data. The superiority primary endpoint was met with 74.1% of subjects in the AXPAXLI (0.45 mg) arm maintaining vision at Week 36, a 17.5% risk difference (p=0.0006), compared to aflibercept (2 mg) arm. 65.9% of subjects treated with AXPAXLI (0.45 mg) maintained vision at Week 52, a 21.1% risk difference (p<0.0001), compared to aflibercept (2 mg) arm.

공시 • Feb 22

Ocular Therapeutix, Inc. Announces Management Changes

Ocular Therapeutix, Inc. announced Board of Directors and leadership updates with the addition of Pravin U. Dugel, MD as Executive Chairman and the additions of Jeffrey S. Heier, MD, Peter K. Kaiser, MD, and Sanjay Nayak, MBBS, PhD to the Ocular management team as Chief Scientific Officer, Medical Director, and Chief Strategy Officer, respectively. The addition of these four acknowledged strategic and clinical experts puts the Company on track to be a leader in retina care for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other retinal conditions. The Company also announced that Charles Warden has transitioned from Chairman of the Board to Lead Independent Director. To enable full transitions to their new operating roles, Dr. Heier has resigned from his positions with the Company as a Board Director and Advisor – Retina, and Dr. Kaiser has resigned from his position as Chief Medical Advisor – Retina of the Company. In addition, Peter Jarrett, PhD, has begun the new role of Chief Technical Officer. Rabia Gurses Ozden, MD, will continue in her role as Chief Medical Officer. Pravin U. Dugel, MD has held previous leadership roles including President of IVERIC Bio, Inc., Managing Partner, Retinal Consultants of Arizona and the Retinal Research Institute; Clinical Professor, USC Eye Institute, Keck School of Medicine, University of Southern California; and Founding Member, Spectra Eye Institute in Sun City, Arizona. Dr. Dugel has authored more than 200 papers and 35 book chapters, and has been invited to give named lectures at marquis medical meetings and to serve as a visiting professor at universities worldwide, including in Japan, India, Nepal, China, Malaysia, Egypt, the United Kingdom, France, Germany, Austria, Italy, Poland, Denmark, Norway, the Czech Republic, Canada, and Australia. He is on the editorial board of several major medical journals. Dr. Dugel is internationally recognized as a major clinical researcher and has been a principal investigator in over 100 multicenter clinical trials. His research and educational contributions earned him the Honor Award, Senior Honor Award and Lifetime Achievement Award from the American Academy of Ophthalmology (AAO). He has been elected and previously served as the Retina Subspecialty Day Board Chairman for the American Academy of Ophthalmology Annual Meeting, as a member of the Board of Directors of the largest retina society in the United States, the American Society of Retina Specialists (ASRS), and the largest retina society in Europe, EURETINA. Additionally, he has been elected to the Retina Society, Macula Society, and the Retina Hall of Fame. Dr. Dugel has served as the Chair of the Scientific Advisory Board for major companies, including Novartis, Roche, Genentech, Allergan (Abbvie), Oxurion (Thrombogenics), Oculis, and Alcon. He has consulted for over 50 companies and has previously served on the IVERIC Bio and Aerpio Therapeutics Boards of Directors. Dr. Dugel has been a member of the Board of Directors and Chair of Orbis International’s Medical Advisory Board and Medical Strategic Committee. Orbis International is a non-profit organization focused on ophthalmology training and education in the developing world. With Orbis, Dr. Dugel travels to developing countries to teach surgical techniques to local ophthalmologists and provide free surgery. In Arizona, Dr. Dugel founded an aviation company allowing him to travel to the Navajo, Hopi and Pima Indian Reservations to treat Native American patients suffering from preventable blindness. Dr. Dugel was born in Kathmandu, Nepal, grew up in Vienna, Austria and attended Harrow School in London, England. He graduated summa cum laude from Columbia University in New York City and was elected to the Phi Beta Kappa Society. He was also captain of the Columbia Squash team. He then attended the UCLA School of Medicine, completing his residency in ophthalmology at the USC Eye Institute, Keck School of Medicine. Thereafter, he completed his medical retina fellowship at the Bascom Palmer Eye Institute and surgical retina fellowship at the USC Eye Institute, where he received both the Heed Foundation Fellowship award and Ronald G. Michels Foundation Fellowship award. Jeffrey S. Heier, MD, is and will continue to serve as the Director of the Vitreoretinal Service and Director of Retina Research at Ophthalmic Consultants of Boston (OCB), one of the largest multi-specialty ophthalmology practices in the United States. Dr. Heier served as Co-President & Medical Director of OCB from 2016-2020. Dr. Heier is the Immediate Past President of the Retina Society and served as a member of the Executive Committee of the American Society of Retina Specialists from 2016 to February 2024. He is the Past President of the New England Ophthalmological Society and a member of the Macula Society. Dr. Heier is one of the leading retinal clinical researchers in the country for new treatments in exudative and non-exudative macular degeneration, diabetic macular edema, venous occlusive disease, vitreoretinal surgical techniques and instrumentation, and diagnostic imaging of the retina. He has served as one of the national or international lead investigators on numerous clinical trial programs, including the Phase 3 trials of pegcetacoplan for advanced dry AMD, aflibercept and ranibizumab for neovascular AMD, and the dexamethasone implant for retinal venous occlusive disease. Dr. Heier serves as the chair of multiple scientific advisory boards and steering committees focusing on study design, outcomes analysis, and implementation of new agents into clinical practice. Dr. Heier has served as the Principal Investigator in more than 200 clinical trials. He lectures nationally and internationally, and has authored over 140 peer-reviewed works. Dr. Heier has received the Life Achievement Honor Award, The Secretariat Award, The Senior Achievement Award, and the Honor Award from the American Academy of Ophthalmology, and The Presidential Honor Award, The Senior Honor Award, and the Honor Award from the American Society of Retina Specialists. Dr. Heier was selected as a charter inductee of the Retina Hall of Fame in 2017. Dr. Heier received his medical degree from Boston University, completed an internship and residency at Fitzsimons Army Medical Center, and a vitreoretinal fellowship at Ophthalmic Consultants of Boston/Tufts School of Medicine. He served as a physician in a Combat Support Hospital in the Persian Gulf War, where he was awarded a Bronze Star. Peter K. Kaiser, MD, was appointed as a Staff member of the vitreoretinal faculty of the Cole Eye Institute at Cleveland Clinic in 1997, where he now holds the Chaney Family Endowed Chair in Ophthalmology Research and will continue to serve as Professor of Ophthalmology at the Cleveland Clinic Lerner College of Medicine.

총 주주 수익률	-31.0%
미래 배당 수익률	0%
배당 성장률	n/a
다음 배당 지급일	n/a
배당락일	n/a
주당 배당금	n/a
배당 성향	n/a

구분	배당 수익률
회사 (OCUL)	n/a
시장 하위 25% (US)	1.4%
시장 상위 25% (US)	4.2%
업계 평균 (Pharmaceuticals)	2.1%
분석가 예측 (OCUL) (최대 3년)	0%

데이터	최종 업데이트 (UTC 시간)
기업 분석	2026/05/22 07:04
종가	2026/05/22 00:00
수익	2026/03/31
연간 수익	2025/12/31

패키지	데이터	기간	미국 소스 예시 ^*
기업 재무제표	10년	손익계산서 현금흐름표 대차대조표	SEC 양식 10-K SEC 양식 10-Q
분석가 컨센서스 추정치	+3년	재무 예측 분석가 목표주가	분석가 리서치 보고서 Blue Matrix
시장 가격	30년	주가 배당, 분할 및 기타 조치	ICE 시장 데이터 SEC 양식 S-1
지분 구조	10년	주요 주주 내부자 거래	SEC 양식 4 SEC 양식 13D
경영진	10년	리더십 팀 이사회	SEC 양식 10-K SEC 양식 DEF 14A
주요 개발	10년	회사 공시	SEC 양식 8-K

분석가	기관
Colleen Kusy	Baird
Anita Dushyanth	Berenberg
Tazeen Ahmad	BofA Global Research

Ocular Therapeutix 배당 및 자사주 매입

배당 기준 점검 0/6

핵심 정보

최근 배당 및 자사주 매입 업데이트

Recent updates

OCUL: SOL-1 Phase 3 Clarity Will Drive Future Retinal Franchise Upside

Ocular Therapeutix Reports Positive Phase 3 Wet AMD Data and Advances NDA Submission for AXPAXLI

Ocular: SOL-1 Success Is Real, But Adoption Risks Keep Me At Hold

Ocular Therapeutix, Inc., Annual General Meeting, Jun 10, 2026

Ocular Therapeutix, Inc. Announces First Patient Enrolled in Sol-X Long-Term Extension Trial for Axpaxli in Wet AMD

OCUL: SOL-1 Data Clarity Will Support Future Retinal Franchise Upside

Ocular Therapeutix, Inc. to Report Q1, 2026 Results on May 05, 2026

OCUL: SOL-1 Phase 3 Data Will Drive Bullish Repricing

Ocular Therapeutix Inc Announces Additional Positive Week 52 Data from Landmark SOL-1 Phase 3 Trial of AXPAXLI in Wet AMD

OCUL: Phase 3 SOL-1 Clarity Will Drive Future Retinal Upside

OCUL: Phase 3 Retinal Data And Potential Sanofi Bid Will Reshape Outlook

OCUL: Higher Sanofi Bid And SOL-1 Data Will Drive Bullish Repricing

OCUL: Potential Higher Sanofi Bid Will Drive Bullish Repricing

OCUL: Potential Sanofi Bid And Phase 3 Milestones Will Drive Repricing

Ocular Therapeutix, Inc. Announces Chief Financial Officer Changes, Effective January 20, 2026

Ocular Therapeutix, Inc. Appoints David W. Robinson As Global Chief Commercial Officer

OCUL: Potential Sanofi Bid And Late Stage Trials Will Reshape Outlook

Ocular Therapeutix, Inc.'s (NASDAQ:OCUL) Stock Retreats 29% But Revenues Haven't Escaped The Attention Of Investors

OCUL: Phase 3 Retinal Program Progress Will Drive Future Upside Potential

Ocular Therapeutics, Inc. Prepares for Database Lock for Its Sol-1 Phase 3 Clinical Trial of Axpaxli

OCUL: Derisked Diabetic Retinopathy Pivotal Program Will Drive Future Upside Potential

Ocular Therapeutix, Inc. Announces Plans to Accelerate NDA Submission Timeline for AXPAXLI in Wet AMD

Ocular Therapeutics, Inc. Intends to submit New Drug Application for its Product Candidate AXPAXLI

OCUL: Pivotal Retinopathy Trial Progress Will Drive Substantial Upside Potential

Ocular Therapeutix™? Announces First Patient Randomized in Helios-3 Phase 3 Registrational Program for Axpaxli™? in Npdr

OCUL: Pivotal Trial Progress in Diabetic Retinopathy Will Drive Long-Term Upside

Ocular Therapeutix, Inc. Achieves Target Randomization of 555 Subjects in SOL-R

OCUL: Pivotal Nonproliferative Diabetic Retinopathy Results Will Drive Future Share Upside

Ocular Therapeutix, Inc. to Report Q3, 2025 Results on Nov 04, 2025

Future Drug Approvals Will Expand Retinal Disease Treatments

Future Drug Approvals Will Expand Retinal Disease Treatments

Ocular Therapeutix, Inc. has completed a Follow-on Equity Offering in the amount of $474.999996 million.

After Leaping 31% Ocular Therapeutix, Inc. (NASDAQ:OCUL) Shares Are Not Flying Under The Radar

Ocular Therapeutix, Inc. to Report Q2, 2025 Results on Aug 05, 2025

Ocular Therapeutix, Inc.(NasdaqGM:OCUL) dropped from Russell 3000E Growth Index

Ocular Therapeutix, Inc.'s (NASDAQ:OCUL) 26% Jump Shows Its Popularity With Investors

Ocular Therapeutix (NASDAQ:OCUL) Has Debt But No Earnings; Should You Worry?

Ocular Therapeutix, Inc. to Close Enrollment This Week for SOL-R, its Second Registrational Trial Evaluating AXPAXLI™? in Wet Age-Related Macular Degeneration

Bearish: Analysts Just Cut Their Ocular Therapeutix, Inc. (NASDAQ:OCUL) Revenue and EPS estimates

Ocular Therapeutix, Inc., Annual General Meeting, Jun 11, 2025

Ocular Therapeutix, Inc. to Report Q1, 2025 Results on May 05, 2025

Why Investors Shouldn't Be Surprised By Ocular Therapeutix, Inc.'s (NASDAQ:OCUL) P/S

FDA Approval And Adjusted Trials Will Expand Treatment Options

Ocular Therapeutix: Axpaxli's Dual Trial Strategy And Blockbuster Potential

Does Ocular Therapeutix (NASDAQ:OCUL) Have A Healthy Balance Sheet?

Ocular Therapeutix Shares Sol-R Enrollment Progress and Next Steps for Axpaxli in NPDR

Ocular Therapeutix Announces More Than 300 Subjects Randomized in Sol-1

Ocular Therapeutix, Inc. Appoints Namrata Saroj, OD, as Chief Business Officer

Ocular Therapeutix, Inc. to Report Q3, 2024 Results on Nov 14, 2024

Is Ocular Therapeutix (NASDAQ:OCUL) Weighed On By Its Debt Load?

Ocular Therapeutix, Inc. Announces Accelerated Timelines for Sol-1 Registrational Trial of AXPAXLI in Wet AMD

Ocular Therapeutix: Focus On Axpaxli's Path To Market In Wet-AMD And Implications To Investors

Earnings Update: Ocular Therapeutix, Inc. (NASDAQ:OCUL) Just Reported Its Second-Quarter Results And Analysts Are Updating Their Forecasts

Ocular Therapeutix, Inc. Announces Fda Feedback That Sol-R Trial Is Appropriate as A Registrational Study in Wet Amd

Ocular Therapeutix, Inc. to Report Q2, 2024 Results on Aug 07, 2024

Ocular Therapeutix, Inc. Announces First Patients Enrolled in Phase 3 Sol-R Wet AMD Study

Ocular Therapeutix: A Speculative Investment For Risk-Tolerant Investors

Ocular Therapeutix, Inc. (NASDAQ:OCUL) Stocks Shoot Up 41% But Its P/S Still Looks Reasonable

Ocular Therapeutix, Inc. (NASDAQ:OCUL) Shares Could Be 45% Below Their Intrinsic Value Estimate

Ocular Therapeutix: Unveiling Pipeline Progress (AXPAXLI, PAXTRAVA) And Q1 Results

Executive Chairman notifies of intention to sell stock

Consensus EPS estimates fall by 23%

First quarter 2024 earnings: EPS and revenues miss analyst expectations

Ocular Therapeutix, Inc. to Report Q1, 2024 Results on May 07, 2024

Ocular Therapeutix, Inc., Annual General Meeting, Jun 12, 2024

Ocular Therapeutix, Inc. Announces Positive Topline Phase 1 Data for AXPAXLI™ in Diabetic Retinopathy

Ocular Therapeutix, Inc. Announces CEO Changes

Consensus EPS estimates fall by 29%

Ocular Therapeutix, Inc. Announces Positive Phase 2 PAXTRAVA™ Glaucoma Data at the American Society of Cataract and Refractive Surgery 2024 Annual Meeting

Ocular Therapeutics' Impressive Surge: A Strategic Insight

Consensus EPS estimates upgraded to US$0.67 loss, revenue downgraded

Full year 2023 earnings: EPS exceeds analyst expectations while revenues lag behind

Ocular Therapeutix, Inc. to Report Q4, 2023 Results on Mar 11, 2024

Ocular Therapeutix, Inc. Announces Management Changes

AffaMed Therapeutics Announces New Drug Application Acceptance by Singapore Health Sciences Authority (HSA) for DEXTENZA