Executive Summary & Business Highlights [Company Overview and Strategic Vision](index=1&type=section&id=Company%20Overview%20and%20Strategic%20Vision) Ocular Therapeutix is entering a pivotal phase, focusing on redefining retina treatment with AXPAXLI™, which aims for a powerful and differentiated clinical profile, potentially securing an unprecedented superiority label in wet AMD with long-term dosing flexibility. The company maintains a strong financial position with a cash runway into 2028 - AXPAXLI™ is expected to achieve a powerful and highly differentiated clinical profile, with the potential to secure an unprecedented superiority label in wet AMD[2](index=2&type=chunk) - The SOL program is anticipated to enable AXPAXLI™ dosing every 6 months to as infrequently as every 12 months[2](index=2&type=chunk) Cash Balance as of June 30, 2025 | Metric | Amount (Millions) | | :----- | :---------------- | | Cash Balance | $391 | - Expected cash runway extends into **2028**, well beyond anticipated topline data for SOL-1 and SOL-R[1](index=1&type=chunk) [Recent Achievements and Upcoming Milestones](index=2&type=section&id=Recent%20Achievements%20and%20Upcoming%20Milestones) Ocular Therapeutix reported significant progress in its AXPAXLI™ clinical trials for wet AMD, including SOL-1 remaining on track for 1Q 2026 topline data and streamlined rescue criteria for SOL-R, with data expected in 1H 2027. The company also plans a long-term extension study, received positive FDA feedback for NPDR and DME programs, raised $97 million, and will host an Investor Day in September 2025 [AXPAXLI™ Clinical Development](index=2&type=section&id=AXPAXLI%E2%84%A2%20Clinical%20Development) - SOL-1 (Phase 3, wet AMD) topline data remains on track for **1Q 2026**, with exceptional patient retention and protocol adherence[3](index=3&type=chunk) - SOL-R (Phase 3, wet AMD) rescue criteria were streamlined and simplified to align with real-world clinical decision-making (criteria: >5-letter loss in visual acuity plus ≥75-micron increase in central subfield thickness). Topline data is expected in **1H 2027**[3](index=3&type=chunk) - New Drug Application (NDA) filing for AXPAXLI™ is planned shortly after SOL-R topline results, utilizing the 505(b)(2) pathway for potentially shorter review[3](index=3&type=chunk) - A single long-term, open-label extension study is planned for patients completing either SOL-1 or SOL-R to provide long-term safety data and inform the AXPAXLI™ treatment paradigm[4](index=4&type=chunk) [Pipeline Expansion (NPDR, DME)](index=3&type=section&id=Pipeline%20Expansion%20(NPDR%2C%20DME)) - Received written feedback from FDA supporting a registrational trial for AXPAXLI™ in non-proliferative diabetic retinopathy (NPDR)[4](index=4&type=chunk) - Actively defining clinical strategy for AXPAXLI™ in NPDR and diabetic macular edema (DME), with more details to be shared at Investor Day[4](index=4&type=chunk) [Corporate and Financial Updates](index=3&type=section&id=Corporate%20and%20Financial%20Updates) - Raised gross proceeds of approximately **$97 million** in June 2025 through an existing at-the-market (ATM) facility, extending financial flexibility and cash runway into **2028**[4](index=4&type=chunk) - Ocular will host an Investor Day on Tuesday, **September 30, 2025**, in New York City, to discuss SOL trials, the extension study, NPDR/DME strategy, and the global commercial opportunity for AXPAXLI™[4](index=4&type=chunk) - Unveiled new corporate branding in June 2025, reflecting the company's transformation to a retina-focused entity committed to redefining the retina experience[4](index=4&type=chunk) Financial Performance (Q2 2025) [Key Financial Highlights](index=4&type=section&id=Key%20Financial%20Highlights) As of June 30, 2025, Ocular Therapeutix reported total cash and cash equivalents of $391.1 million, which is projected to fund operations into 2028, well beyond the anticipated topline data for its key clinical trials Cash and Cash Equivalents (as of June 30, 2025) | Metric | Amount (Millions) | | :----- | :---------------- | | Cash and cash equivalents | $391.1 | - Current cash balance is sufficient to support planned expenses, debt service, and capital expenditure requirements into **2028**[5](index=5&type=chunk) [Revenue Analysis](index=4&type=section&id=Revenue%20Analysis) Total net revenue for Q2 2025 decreased by 18.1% year-over-year to $13.5 million, primarily due to a challenging reimbursement environment for DEXTENZA. Despite this, DEXTENZA end-user unit sales increased by 5% YoY, and net product revenue grew by 26.0% quarter-over-quarter Total Net Revenue (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :----- | :----------------- | :----------------- | :--------- | | Total Net Revenue | $13.5 | $16.4 | -18.1% | - DEXTENZA end-user unit sales increased by **5%** compared to Q2 2024[7](index=7&type=chunk) - DEXTENZA net product revenue increased by **26.0%** compared to Q1 2025[7](index=7&type=chunk) - The reduction in net revenue was attributed to an evolving and significantly more challenging reimbursement environment for DEXTENZA in 2025[7](index=7&type=chunk) [Operating Expenses](index=4&type=section&id=Operating%20Expenses) Research and development expenses significantly increased by 76.8% YoY to $51.1 million in Q2 2025, driven by increased clinical activities for the SOL-1 and SOL-R trials. Selling and marketing expenses also rose by 37.0% to $13.7 million due to pre-commercialization efforts for AXPAXLI™. General and administrative expenses decreased by 27.4% to $14.3 million, primarily due to one-time costs in the prior year Operating Expenses (Q2 2025 vs Q2 2024) | Expense Category | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :--------------- | :----------------- | :----------------- | :--------- | | R&D Expenses | $51.1 | $28.9 | +76.8% | | S&M Expenses | $13.7 | $10.0 | +37.0% | | G&A Expenses | $14.3 | $19.7 | -27.4% | - Increase in R&D expenses reflects higher overall clinical expenses associated with the SOL-1 and SOL-R Phase 3 clinical trials, as well as additional personnel and professional services[8](index=8&type=chunk) - Increase in S&M expenses primarily reflects higher personnel-related costs and professional fees for AXPAXLI™ pre-commercialization activities[9](index=9&type=chunk) - Decrease in G&A expenses was primarily due to lower personnel-related costs, as Q2 2024 included one-time costs for departed employees and restructuring[10](index=10&type=chunk) [Net Loss and EPS](index=4&type=section&id=Net%20Loss%20and%20EPS) Ocular Therapeutix reported a net loss of $(67.8) million, or $(0.39) per share, for Q2 2025, an increase from $(43.8) million, or $(0.26) per share, in the comparable quarter of 2024, primarily driven by increased operating expenses Net Loss and EPS (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :----- | :----------------- | :----------------- | :--------- | | Net Loss | $(67.8) | $(43.8) | +54.8% | | Net Loss per Share (Basic & Diluted) | $(0.39) | $(0.26) | +50.0% | - Outstanding shares as of August 1, 2025, were approximately **174.0 million**[12](index=12&type=chunk) Product and Disease Background [About AXPAXLI™](index=5&type=section&id=About%20AXPAXLI%E2%84%A2) AXPAXLI™ (OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel that incorporates axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic properties. It is currently being evaluated for the treatment of wet AMD, diabetic retinopathy, diabetic macular edema, and other retinal diseases - AXPAXLI™ (OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel[13](index=13&type=chunk) - It incorporates axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties[13](index=13&type=chunk) - AXPAXLI™ is being evaluated for wet AMD, diabetic retinopathy, diabetic macular edema, and other retinal diseases[13](index=13&type=chunk) [About SOL-1 Study](index=5&type=section&id=About%20SOL-1%20Study) The SOL-1 trial is a registrational Phase 3 superiority study evaluating AXPAXLI™ against aflibercept (2 mg) in 344 treatment-naïve wet AMD subjects. The primary endpoint is the proportion of subjects maintaining visual acuity at Week 36, with durability evaluated up to Week 52. The study is conducted under an FDA Special Protocol Assessment (SPA) - SOL-1 is a registrational Phase 3, multi-center, double-masked, randomized (1:1), parallel group superiority study[14](index=14&type=chunk)[15](index=15&type=chunk) - The trial completed randomization of **344** evaluable treatment-naïve subjects with wet AMD[14](index=14&type=chunk) - The primary endpoint is the proportion of subjects who maintain visual acuity (loss of <15 ETDRS letters of BCVA) at Week 36[16](index=16&type=chunk) - The study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA[16](index=16&type=chunk) [About SOL-R Study](index=6&type=section&id=About%20SOL-R%20Study) The SOL-R trial is a registrational Phase 3 non-inferiority study designed to evaluate AXPAXLI™ in approximately 555 wet AMD subjects. The primary endpoint is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI™ and on-label aflibercept (2 mg) arms at Week 56, with a pre-specified non-inferiority margin of -4.5 letters - SOL-R is a registrational Phase 3, multi-center, double-masked, randomized (2:2:1), three-arm non-inferiority study[17](index=17&type=chunk)[19](index=19&type=chunk) - The trial intends to randomize approximately **555** subjects who are treatment-naïve or recently diagnosed with wet AMD[17](index=17&type=chunk) - The primary endpoint is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI™ and on-label aflibercept (2 mg) arms at Week 56[19](index=19&type=chunk) - The non-inferiority margin for the lower bound is **-4.5 letters** of mean BCVA, as agreed with the FDA[19](index=19&type=chunk) - Pre-specified rescue criteria include a >5-letter loss in visual acuity plus a ≥75-micron increase in central subfield thickness (CSFT)[18](index=18&type=chunk) [About Wet AMD](index=6&type=section&id=About%20Wet%20AMD) Wet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss, affecting millions globally. It is characterized by abnormal blood vessel growth and hyperpermeability, primarily stimulated by VEGF. Current treatments involve frequent intraocular injections, which often lead to patient discontinuation and undertreatment, highlighting the need for more sustainable solutions - Wet AMD affects approximately **14.5 million** individuals globally and **1.8 million** in the United States[20](index=20&type=chunk) - It causes vision loss due to abnormal new blood vessel growth and hyperpermeability in the macula, primarily stimulated by vascular endothelial growth factor (VEGF)[20](index=20&type=chunk) - Challenges with current therapies include pulsatile, repeated intraocular injections, treatment-related adverse events, and up to **40%** patient discontinuation within one year, leading to undertreatment and lack of long-term vision improvement[20](index=20&type=chunk) Corporate Information [About Ocular Therapeutix, Inc.](index=7&type=section&id=About%20Ocular%20Therapeutix%2C%20Inc.) Ocular Therapeutix is an integrated biopharmaceutical company focused on redefining the retina experience through its proprietary ELUTYX™ bioresorbable hydrogel technology. Its pipeline includes AXPAXLI™ (Phase 3 for wet AMD), the commercial product DEXTENZA (for ocular inflammation/pain/itching), and OTX-TIC (Phase 2 for open-angle glaucoma/ocular hypertension) - Ocular Therapeutix is an integrated biopharmaceutical company committed to redefining the retina experience[21](index=21&type=chunk) - The company leverages its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology[21](index=21&type=chunk) - Key products and candidates include AXPAXLI™ (Phase 3 for wet AMD), DEXTENZA (FDA-approved for ocular inflammation, pain, and allergic conjunctivitis), and OTX-TIC (Phase 2 for open-angle glaucoma or ocular hypertension)[21](index=21&type=chunk)[22](index=22&type=chunk) [Forward-Looking Statements](index=8&type=section&id=Forward-Looking%20Statements) This section outlines that statements regarding future expectations, plans, and prospects are forward-looking and subject to substantial risks and uncertainties. Actual results may differ materially from those indicated, and the company disclaims any obligation to update these statements unless required by law - Statements about future expectations, plans, and prospects constitute forward-looking statements[24](index=24&type=chunk) - Actual results may differ materially from forward-looking statements due to various important factors, risks, and uncertainties[24](index=24&type=chunk) - The company disclaims any obligation to update these forward-looking statements, except as required by law[24](index=24&type=chunk) [Investor Relations](index=8&type=section&id=Investor%20Relations) This section provides contact information for investor and media inquiries - Contact for Investors & Media: Bill Slattery, Vice President, Investor Relations[25](index=25&type=chunk) Financial Statements [Consolidated Balance Sheets](index=9&type=section&id=Consolidated%20Balance%20Sheets) The Consolidated Balance Sheets present the company's financial position as of June 30, 2025, and December 31, 2024, detailing assets, liabilities, and stockholders' equity. Total assets slightly decreased from $457.9 million to $451.3 million, while total liabilities increased from $142.6 million to $145.4 million, and total stockholders' equity decreased from $315.3 million to $305.9 million Consolidated Balance Sheets (Selected Data in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $391,134 | $392,102 | | Total current assets | $433,375 | $440,987 | | Total assets | $451,333 | $457,935 | | **Liabilities** | | | | Total current liabilities | $42,931 | $41,354 | | Total liabilities | $145,417 | $142,591 | | **Stockholders' Equity** | | | | Total stockholders' equity | $305,916 | $315,344 | [Consolidated Statements of Operations and Comprehensive Loss](index=10&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The Consolidated Statements of Operations and Comprehensive Loss detail the company's financial performance for the three and six months ended June 30, 2025, and 2024. For Q2 2025, total net revenue was $13.5 million, operating expenses were $81.1 million, resulting in a net loss of $(67.8) million, or $(0.39) per share. This represents an increased net loss compared to Q2 2024 Consolidated Statements of Operations (Selected Data in thousands, except per share) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenue, net | $13,459 | $16,441 | $24,156 | $31,215 | | Total costs and operating expenses | $81,100 | $60,031 | $155,715 | $106,422 | | Loss from operations | $(67,641) | $(43,590) | $(131,559) | $(75,207) | | Net loss | $(67,814) | $(43,777) | $(131,867) | $(108,625) | | Net loss per share, basic | $(0.39) | $(0.26) | $(0.77) | $(0.73) | | Weighted average common shares outstanding, basic | 172,594,662 | 165,824,778 | 171,004,629 | 148,922,937 |

Core Insights - Ocular Therapeutix is advancing its clinical trials for AXPAXLI, targeting wet age-related macular degeneration (AMD) with significant milestones expected in 2026 and 2027 [1][2][3] Clinical Trials and Development - SOL-1 trial is on track for topline data in Q1 2026, while SOL-R trial is expected to report topline data in H1 2027 [1][3] - A long-term extension study for both SOL trials is planned to follow patients after completion, aiming to gather additional safety and efficacy data [1][6] - SOL-R has streamlined rescue criteria to align with real-world clinical practices, enhancing its relevance and applicability [3][4] Financial Performance - As of June 30, 2025, the company reported a cash balance of $391.1 million, sufficient to support operations into 2028 [5][6] - Total net revenue for Q2 2025 was $13.5 million, an 18.1% decrease from $16.4 million in Q2 2024, attributed to a challenging reimbursement environment [7][8] - Research and development expenses increased to $51.1 million in Q2 2025, reflecting the costs associated with ongoing clinical trials [9] Strategic Initiatives - The company raised approximately $97 million in gross proceeds through an at-the-market facility in June 2025, enhancing financial flexibility [5][6] - An Investor Day is scheduled for September 30, 2025, to discuss the clinical strategy and commercial outlook for AXPAXLI [5][6] Market Context - Wet AMD affects approximately 14.5 million individuals globally, highlighting a significant market opportunity for innovative treatments like AXPAXLI [22] - Current therapies face challenges such as treatment burden and high patient discontinuation rates, indicating a need for more sustainable treatment options [22]

Core Viewpoint - Ocular Therapeutix, Inc. is set to discuss its recent business progress and financial results for Q2 2025 in an upcoming conference call on August 5, 2025 [1]. Group 1: Company Overview - Ocular Therapeutix, Inc. is a biopharmaceutical company focused on redefining the retina experience [3]. - The company is developing AXPAXLI™ (OTX-TKI), an investigational product for retinal disease, currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) [3]. - Ocular's pipeline includes DEXTENZA, an FDA-approved corticosteroid for treating ocular inflammation and pain post-surgery, and OTX-TIC, an investigational product in Phase 2 trials for open-angle glaucoma or ocular hypertension [4]. Group 2: Conference Call Details - The conference call and webcast will take place on August 5, 2025, at 8:00 AM ET [2]. - Participants can join via U.S. dial-in at 1-877-407-9039 or international dial-in at 1-201-689-8470 [2]. - The live and archived webcast will be accessible on the Ocular Therapeutix website for at least 30 days [2].

Core Insights - Ocular Therapeutix, Inc. is actively participating in several scientific conferences in July and August 2025, showcasing its commitment to advancing retinal therapies [1] Conference Participation - Ocular Therapeutix will present at the 8th Annual OIS Retina Innovation Summit on July 29, 2025, focusing on drug delivery, with Sanjay Nayak as the presenter [2] - At the American Society of Retinal Specialists (ASRS) 2025 Annual Scientific Meeting on July 31, 2025, Ocular will present research on diabetic retinopathy, including a study on Axitinib Hydrogel [3] - The company will also present a poster at the Women in Ophthalmology (WIO) 2025 conference on August 9-10, 2025, discussing macular fluid volume and retinal vascular leakage [4] Product Pipeline - Ocular Therapeutix is developing AXPAXLI™ (OTX-TKI), an investigational axitinib intravitreal hydrogel for retinal diseases, currently in Phase 3 trials for wet age-related macular degeneration [5] - The company’s pipeline includes DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain, and OTX-TIC, a travoprost intracameral hydrogel in Phase 2 trials for open-angle glaucoma [6][7]

Core Insights - Ocular Therapeutix has launched a new corporate branding and website, marking a significant transformation towards becoming a retina-focused company [1][8] - The new branding reflects the company's innovative vision and commitment to redefining the retina experience, particularly in the treatment of retinal diseases [3][6] Company Overview - Ocular Therapeutix, Inc. is a biopharmaceutical company dedicated to redefining the retina experience, with a focus on innovative treatments for retinal diseases [9] - The investigational therapy AXPAXLI™ (OTX-TKI) is an axitinib hydrogel designed for intravitreal injection, aimed at improving treatment durability and long-term outcomes for patients with wet age-related macular degeneration (wet AMD) [7][9] Market Context - Wet AMD affects approximately 1.8 million people in the U.S., and current treatment options often require up to 12 injections per year, leading to patient burden and potential treatment discontinuation [6] - The company aims to disrupt existing treatment paradigms for retinal diseases, addressing the high burden associated with current pulsatile treatments [6][3] Product Pipeline - Ocular's pipeline includes AXPAXLI™, currently in Phase 3 clinical trials for wet AMD, and DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain [10] - The investigational product OTX-TIC is in Phase 2 clinical trials for open-angle glaucoma or ocular hypertension, leveraging the company's proprietary ELUTYX™ technology [10]

Company Overview - Ocular Therapeutix (OCUL) shares increased by 8.6% to $9.09 in the last trading session, with a notable trading volume, and have gained 14.7% over the past four weeks [1][2] Pipeline and Product Development - The price rise is linked to positive investor sentiment regarding Ocular's product candidate Axpaxli, which is in late-stage studies for treating wet age-related macular degeneration, diabetic retinopathy, diabetic macular edema, and other retinal diseases [2] Financial Performance Expectations - The company is projected to report a quarterly loss of $0.35 per share, reflecting a year-over-year decline of 45.8%, with expected revenues of $13.55 million, down 17.6% from the previous year [3] - The consensus EPS estimate for the quarter has been revised 1.2% higher in the last 30 days, indicating a potential for price appreciation [4] Industry Context - Ocular Therapeutix is part of the Zacks Medical - Drugs industry, where Takeda Pharmaceutical Co. (TAK) also operates, having seen a 2.5% increase to $15.08 in the last trading session [5] - Takeda's consensus EPS estimate remains unchanged at $0.47, representing a year-over-year decline of 16.1%, and it currently holds a Zacks Rank of 4 (Sell) [6]

AXPAXLI for Wet AMD - AXPAXLI aims to redefine the wet AMD market with its highly selective pan-VEGF inhibition and sustained drug delivery via ELUTYX technology[29, 31] - The SOL-1 trial is designed as a superiority study comparing a single dose of AXPAXLI to a single 2mg dose of aflibercept at Week 36, with topline data expected in Q1 2026[45, 48] - The SOL-R trial is designed as a non-inferiority study comparing AXPAXLI Q24W to aflibercept 2mg Q8W at Week 56, with a non-inferiority margin of -45 letters in BCVA[50] - As of January 10, 2025, 311 subjects were enrolled in the SOL-R trial across various stages of loading and randomization[53] - Phase 1 data showed 100% rescue-free rate per protocol at 6 months and 80% at 10 months in a US wet AMD trial with AXPAXLI treatment[39, 41, 111] AXPAXLI for Diabetic Retinopathy (DR) - In the U S, 72% of the 88 million DR patients have NPDR, but less than 1% of NPDR patients are treated[61] - Phase 1 HELIOS study of AXPAXLI in NPDR showed no disease progression to PDR or CI-DME in the AXPAXLI arm at Week 48, compared to 375% in the sham arm[72] Market and Financial Considerations - There are 16 million people with wet AMD in the U S [16] - The company's strong cash position of $3921 million is expected to fund operations into 2028[124]

Core Insights - Ocular Therapeutix, Inc. is participating in Clinical Trials at the Summit 2025, highlighting its commitment to advancing retinal therapies [1][4]. Company Overview - Ocular Therapeutix is a fully-integrated biopharmaceutical company focused on redefining the retina experience [4]. - The company’s investigational product AXPAXLI™ (OTX-TKI) is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) [4]. - Ocular's pipeline includes DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain, and PAXTRAVA™ (OTX-TIC), which is in Phase 2 trials for open-angle glaucoma or ocular hypertension [5]. Presentation Details - Ocular will present at the Clinical Trials at the Summit 2025, with multiple sessions focused on Tyrosine Kinase Inhibitors [2][3]. - Key presentations include results from the US Phase 1 study of OTX-TKI for wet AMD and safety and efficacy data for diabetic retinopathy [6].

Core Insights - Ocular Therapeutix has successfully completed enrollment for the SOL-R trial, the largest retinal TKI trial to date, with a target randomization of at least 555 subjects [1][2][6] - The SOL-1 trial, which is complementary to SOL-R, completed randomization in December 2024 and is on track for top-line readout in Q1 2026 [1][2] - Both trials are designed to support a New Drug Application (NDA) submission for AXPAXLI in wet age-related macular degeneration (wet AMD) [1][3][4] Company Overview - Ocular Therapeutix is a fully-integrated biopharmaceutical company focused on redefining the retina experience [14] - AXPAXLI, the investigational product candidate, is a bioresorbable intravitreal hydrogel incorporating axitinib, aimed at treating wet AMD and other retinal diseases [5][14] - The company is leveraging its proprietary ELUTYX technology in both AXPAXLI and its commercial product DEXTENZA [15] Clinical Trials - The SOL-R trial is a Phase 3 registrational study evaluating the safety and efficacy of AXPAXLI, involving approximately 100 sites across the U.S., Argentina, India, and Australia [6][8] - The primary endpoint of SOL-R is to demonstrate non-inferiority in mean change in best corrected visual acuity (BCVA) compared to aflibercept at Week 56, with a non-inferiority margin of -4.5 letters [8][11] - The SOL-1 trial aims to evaluate the proportion of subjects maintaining visual acuity at Week 36, with a focus on durability up to Week 52 [11][9] Market Context - Wet AMD is a leading cause of blindness, affecting approximately 14.5 million individuals globally and 1.7 million in the U.S. [12][13] - Current treatments face challenges such as the need for frequent injections and high patient discontinuation rates, highlighting the need for more durable therapies [13] - AXPAXLI has the potential to significantly reduce treatment burden and improve long-term vision outcomes for patients with wet AMD [3][4]

Summary of Ocular Therapeutix (OCUL) Conference Call Company Overview - **Company**: Ocular Therapeutix (OCUL) - **Event**: 2025 Conference on May 27, 2025 - **Key Speaker**: Praveen Dugal, Executive Chairman, President, and CEO Core Industry Insights - **Industry**: Ophthalmology, specifically focusing on treatments for retinal diseases - **Market Context**: The anti-VEGF (vascular endothelial growth factor) market has been established for over 20 years, with ongoing unmet needs for longer-duration treatments [7][10] Key Points and Arguments 1. **Need for Innovation**: There is a significant need for improved treatment options in the anti-VEGF market, as nearly 40% of patients drop out of treatment within the first year due to the unsustainability of frequent injections [10][11] 2. **Product Technology**: Ocular Therapeutix's product, ex-Paxley, is a tunable, completely dissolvable hydrogel that has shown to be safe and efficacious based on consistent data [4][5] 3. **Regulatory Pathway**: The company has a clear regulatory path forward, having received Special Protocol Assessment (SPA) from the FDA for their studies, which aligns with the latest FDA guidelines [5][40] 4. **Treatment Paradigm Shift**: ex-Paxley is positioned to potentially replace existing anti-VEGF treatments as a first-line agent due to its efficacy and the ability to provide longer-lasting results [22][23] 5. **Patient Selection**: The company emphasizes the importance of proper patient selection in clinical trials, aiming to identify patients who will benefit most from the treatment [30][31] 6. **Study Design**: The company has designed two complementary studies (SOLAR and SOLA-one) to gather comprehensive data, with a focus on patient stability and response to treatment [44][45] 7. **Market Opportunity**: The market for retinal disease treatments is vast, and Ocular Therapeutix is confident in its ability to capture significant market share due to its innovative product and strong regulatory support [60] Additional Important Insights - **Retention Rates**: The company has reported unprecedented patient retention rates in their studies, which they attribute to the quality of patient selection and the nature of the treatment [54] - **Regulatory Collaboration**: Ocular Therapeutix has established a strong collaborative relationship with the FDA, which has facilitated a smoother regulatory process for their studies [50] - **Future Outlook**: The company is optimistic about the future of ex-Paxley and its potential to dominate the market once the macroeconomic environment stabilizes [59][60] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting Ocular Therapeutix's strategic positioning within the ophthalmology industry and its innovative approach to addressing unmet patient needs.