BEDFORD, Mass., July 10, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, "Ocular", the "Company"), a biopharmaceutical company committed to enhancing people's vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today announced that a late-breaking abstract related to the Phase 1 HELIOS study of AXPAXLI (axitinib intravitreal imp ...

Mr. Rao's inducement awards were granted effective as of July 1, 2024. Mr. Rao's inducement awards consist of (i) a non-statutory stock option to purchase up to 20,000 shares of the Ocular's common stock at a per share exercise price equal to the closing price of Ocular's common stock on The Nasdaq Global Market on July 1, 2024, and (ii) a restricted stock unit award representing the right to receive 6,666 shares of Ocular's common stock. The stock option has a ten-year term and is scheduled to vest over fo ...

AXPAXLI Clinical Trials & Data - AXPAXLI has demonstrated proof-of-concept in three Phase 1 trials for retinal diseases [2, 130] - In a Phase 1 US trial, 80% of wet AMD patients remained rescue-free per protocol for up to 10 months [5, 134] - Phase 1 Australia Trial showed Monotherapy Activity with CSFT improving from 484µm at baseline to 244µm at Month 9, and BCVA improving from 56 letters (20/80) at baseline to 81 letters (20/25) at Month 9 [3] - HELIOS Phase 1 study in NPDR showed 231% ≥2-step DRSS improvement in AXPAXLI arm at week 48 compared to 0% in sham [261] - In HELIOS Phase 1 study, 0% of patients in the AXPAXLI arm developed PDR or CI-DME at Week 48, compared to 375% in the sham arm [248, 263] SOL-1 Trial - SOL-1 is a multi-center, double-masked, randomized, parallel-group trial with ~150 subjects per group [29, 74] - The primary endpoint of SOL-1 is the proportion of subjects who maintained visual acuity, defined as <15 ETDRS letters of BCVA loss at Week 36 [7, 74] - SOL-1 trial design has been adapted to fit the FDA guidance requirements, including a Special Protocol Assessment (SPA) [48, 50, 143] - Enrollment in the SOL-1 trial has been rapid, with 60 sites activated and 151 subjects enrolled as of May 2024 [91, 99] SOL-R Trial - SOL-R is a Phase 3 wet AMD study designed to demonstrate that AXPAXLI Q6M is non-inferior to fixed-dose aflibercept 2 mg Q8W [114] - The SOL-R trial will enroll 825 total subjects and is being conducted at regulatory risk [114] - SOL-R will capture patients who fail loading or randomization in SOL-1, as well as enroll similar wet AMD patients from other sites [116, 117] Market Opportunity - The estimated US market potential for retinal vascular diseases in 2024 is 92 million, including 165 million for wet AMD, 27 million for moderate-severe NPDR, 14 million for RVO, 17 million for DME, and 17 million for PDR [16]

About Ocular Therapeutix, Inc. 151 subjects enrolled in various stages of loading and randomization in SOL-1 pivotal study of AXPAXLI in wet AMD as of June 7, 2024 48-week HELIOS NPDR results show 23.1% of patients in AXPAXLI arm experienced ≥2-step DRSS improvement with no patients experiencing worsening of DRSS or vision threatening complications "2024 has been a time of significant accomplishment for Ocular. To support our mission to become a leader in retinal care, we successfully assembled a 'Retina Dr ...

Core Insights - Ocular Therapeutix, Inc. will host an Investor Day on June 13, 2024, focusing on corporate strategy, clinical data, and development plans for AXPAXLI™ in treating wet AMD and NPDR [1][2] - The event will feature presentations from senior company leaders and discussions with key opinion leaders in retinal disease [2][7] - A live webcast of the presentation will be available on the company's website, with a replay accessible for at least 30 days [3] Company Overview - Ocular Therapeutix is a biopharmaceutical company dedicated to developing innovative therapies for eye diseases, including wet AMD and diabetic retinopathy [9] - AXPAXLI™ is a product candidate based on the ELUTYX™ proprietary bioresorbable hydrogel technology, currently in a Phase 3 clinical trial for wet AMD [9] - The company also has other clinical assets, including PAXTRAVA™, which is in a Phase 2 trial for open-angle glaucoma [10] Key Opinion Leaders - Baruch D. Kuppermann, MD, PhD, is a prominent figure in retinal disease research, serving as the Steinert Endowed Professor and Director of the Gavin Herbert Eye Institute at UC Irvine [4][5] - Dilsher S. Dhoot, MD, is a board-certified ophthalmologist with extensive experience in clinical research for retinal diseases [6][8] Clinical Programs - The Investor Day will provide updates on Ocular's clinical program for AXPAXLI in wet AMD, including progress on the ongoing SOL-1 study [7] - An update on Phase 1 HELIOS data for AXPAXLI in non-proliferative diabetic retinopathy (NPDR) will also be discussed [7]

Core Viewpoint - Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on innovative eye treatment therapies, with a strong emphasis on its pipeline product Axpaxli, which has the potential to capture a significant market share in the wet age-related macular degeneration (wet AMD) market, estimated to be a decabillion-dollar total addressable market (TAM) if successfully developed and commercialized [1][22]. Company Overview - Ocular Therapeutix was founded in 2006 and is based in Bedford, Massachusetts, specializing in novel therapies for eye conditions using its proprietary drug delivery platform, Elutyx [2]. - The company’s leading product, Dextenza, generated net product revenue of $57.9 million in 2023 and has treated approximately 400,000 eyes [3][4]. Product Pipeline - The pipeline includes Axpaxli, an axitinib intravitreal implant currently in phase 3 trials for wet AMD and phase 1/2 trials for diabetic retinopathy, with significant milestones expected in 2024 [4][12]. - Other candidates include OTX-DED for episodic dry eye disease and OTX-CSI for chronic dry eye disease, both progressing through clinical trials [2][8][9]. - Paxtrava (OTX-TIC), a travoprost intracameral implant for glaucoma and ocular hypertension, is in phase 2 trials, with positive topline results expected in April 2024 [6][10]. Market Potential - The wet AMD market is projected to generate revenues of $10.4 billion in 2024, with Axpaxli positioned as a potential best-in-class treatment due to its ability to reduce the frequency of injections by 92% compared to current alternatives [12][15]. - The company has a partnership with AffaMed Therapeutics to expand Dextenza and Paxtrava into Asian markets, with significant progress in regulatory submissions [10]. Financial Overview - Ocular Therapeutix has a market capitalization of $882.9 million and is projected to generate $78.8 million in sales by 2025, indicating a high forward price-to-sales (P/S) ratio of 11.2 compared to the sector median of 3.63 [13][14]. - The company holds $482.9 million in cash against long-term debt of $66.5 million, providing a healthy cash runway of approximately 3.5 years [17][18]. Conclusion - Ocular Therapeutix is transitioning from clinical to commercial stages, with Dextenza as the current revenue source and Axpaxli as the main value driver. The potential for Axpaxli in a large market, combined with a solid financial position, supports a favorable investment outlook [22].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36554 Ocular Therapeutix, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdi ...

Exhibit 99.1 "Ocular's excellent progress in 2024 has put the Company on track to becoming a leading retinal care company. We have substantially enriched the organization with the appointment of recognized leaders in retinal care and clinical development; have completed a successful financing of $325 million in gross proceeds from existing and new top-tier healthcare investors; and have progressed our Phase 3 program for AXPAXLI™ in wet AMD," said Pravin U. Dugel, MD, Executive Chairman, President and Chief ...

BEDFORD, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL) ("Ocular"), a biopharmaceutical company committed to enhancing people's vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today announced that it has agreed to grant inducement awards to (i) its newly appointed Vice President, Head of Programming & Data Ope ...

BEDFORD, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, "Ocular", the "Company"))), a biopharmaceutical company committed to enhancing people's vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today announced that it will participate at two investor conferences in May: Citizens JMP Life Sciences Conference Fire ...