思宇年度活动回顾： 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 | 首届全球医美科技大会 即将召开： 2025年7月17日，第二届全球医疗科技大会 2025年9月3-5日，第三届全球手术机器人大会 近日， EyePoint公司 宣布其 湿性年龄相关性黄斑变性（nAMD） 候选产品 Duravyu的三期 LUGANO 研究 提 前完成患者招募。 短短 7 个月内，超过400名受试者完成入组并随机分组，这标志着该 药械合一控释植入剂 在 nAMD治疗中的临床推进进入关键阶段。 Duravyu 通过 EyePoint 专有的缓释技术 Durasert ETM，将伏罗尼布制为固体可生物降解的植入剂进行药物递 送。 根据公司规划， LUGANO 试验的初步数据将在2026年中期公布，后续LUCIA研究结果预计于 2026年下半年发布 。 LUCIA试验目前已随机分组60%的患者，预计2025年第三季度完成招募。 本轮进展不仅推动Duravyu临近商业化节点，也使其成为 "半年一针" 持续释放 治疗方案中最受瞩目的候选之 一。这一发展，正嵌入眼科控释治疗从基础探索走向结构重塑的背景逻辑中。 # 频繁注 ...

Susvimo can help people with diabetic retinopathy (DR) maintain their vision and prevent progression to blindness with only one treatment every nine monthsSusvimo’s innovative technology via the Port Delivery Platform may offer an alternative to regular eye injections in the USDiabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for treating neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema ...

Ocular Therapeutix (OCUL) 2025 Conference May 20, 2025 02:35 PM ET Speaker0 Capital Markets and it is our great privilege to have Ocular Therapeutics joining us for a fireside chat. Representing the company we have Praveen Dugal, Executive Chair, President, and CEO. Praveen, thanks so much for joining us. How are you doing today? Speaker1 Great, Lisa, and thank you. Thank you for having us on this great conference. An honor to be here, and thank you for the invitation. Speaker0 Excellent. Well, Praveen, jus ...

Summary of Ocular Therapeutix (OCUL) Conference Call Company Overview - **Company**: Ocular Therapeutix (OCUL) - **Product**: ExPaxly, a treatment for wet age-related macular degeneration (AMD) Key Industry Insights - **Regulatory Environment**: The FDA remains consistent and collaborative, with no recent changes affecting timelines or processes [3][4][5] - **Market Context**: The wet AMD market is crowded with existing treatments, including recent generic launches [6] Core Product Differentiation - **ExPaxly's Unique Selling Proposition**: - Aims to address the high dropout rate of 40% in current treatments, which leads to significant patient blindness [11][52] - Offers less frequent dosing, potentially every six to twelve months, compared to current treatments requiring monthly or bi-monthly visits [13][58] - Focuses on sustainability and better long-term outcomes by providing a constant drug delivery, reducing the risk of fibrosis and atrophy [19][18] Clinical Trials - **Current Trials**: - **SOUL-one**: A superiority trial designed to select patients with high VEGF receptor levels [21][25] - **SOLAR**: A non-inferiority trial aimed at ensuring stability in patient responses [21][26] - **Trial Design**: - Both trials are complementary, allowing for a comprehensive understanding of ExPaxly's efficacy and safety [22][28] - The trials have been designed to maximize patient retention and minimize dropout rates [29][44] Regulatory Strategy - **SPA (Special Protocol Assessment)**: The company has maintained its SPA with the FDA, allowing for an extended study period to gather more safety data [44][48] - **Amendments**: Recent amendments to the trials have reduced the number of patients needed for SOLAR, expediting the process while maintaining compliance with FDA guidelines [45][47] Market Potential and Economic Impact - **Patient Retention**: A reduction in dropout rates could lead to significant cost savings for the healthcare system, with estimates of preventing a quarter million patients from going blind [53][60] - **Future Indications**: Plans to expand into non-proliferative diabetic retinopathy and diabetic macular edema, leveraging the efficacy of ExPaxly in these conditions [60][62] Conclusion - **Company's Focus**: Ocular Therapeutix is laser-focused on the success of its clinical trials for ExPaxly, with a strong emphasis on maximizing shareholder value and ensuring a positive impact on patient care [61][64]