Core Insights - Kalaris Therapeutics has initiated a Phase 1b/2 multiple ascending dose study for TH103 in patients with neovascular age-related macular degeneration (nAMD) to assess safety and preliminary efficacy [1][2] - The study aims to evaluate multiple dose levels of TH103 in up to 80 nAMD patients, with assessments expected to include safety and preliminary efficacy [1][2] - Initial data from the Phase 1b/2 study is anticipated in the second half of 2026, while data from the ongoing Phase 1a study is expected in Q4 2025 [1][6] Company Overview - Kalaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for prevalent retinal diseases, particularly those with significant unmet medical needs [8] - The company was founded by Dr. Napoleone Ferrara, who is known for his pioneering research in anti-VEGF therapy [8] - Kalaris is committed to advancing novel therapeutic approaches for conditions such as nAMD, diabetic macular edema (DME), and retinal vein occlusion (RVO) [8] Product Insights - TH103 is a dual-action investigational therapy designed to provide increased and longer-lasting anti-VEGF activity for treating exudative and neovascular retinal diseases [6] - The drug is currently being evaluated in both a Phase 1a single ascending dose study and the newly initiated Phase 1b/2 multiple ascending dose study [6][1] - TH103 represents a novel molecular approach to treatment, building on extensive research in anti-VEGF mechanisms [6][4] Industry Context - Neovascular age-related macular degeneration (nAMD) is a leading cause of vision loss in individuals over 50, affecting millions globally [5] - Despite advancements in anti-VEGF therapies, many patients still experience progressive vision loss, indicating a need for continued innovation in treatment options [5]

Core Viewpoint - Bayer's Eylea 8 mg has received a positive opinion from the CHMP of the EMA for label extension, allowing longer treatment intervals for nAMD and DME, pending European Commission approval [1][2]. Group 1: Product Details - Eylea 8 mg will enable treatment intervals of up to six months for nAMD and DME, making it the only anti-VEGF therapy in the EU with such intervals if approved [2]. - The positive opinion is backed by three-year results from pivotal studies, showing that 24% of nAMD patients and 28% of DME patients achieved a final dosing interval of six months [3]. - Eylea 8 mg has maintained a favorable safety profile over three years, with no new safety concerns reported [5]. Group 2: Market Performance - Bayer's shares have increased by 41.8% year-to-date, contrasting with a 5.2% decline in the industry [2]. - Eylea is a blockbuster drug, currently approved in over 50 markets for nAMD and DME, with ongoing applications for regulatory approvals in additional markets [6]. Group 3: Collaboration and Sales - Bayer co-develops Eylea with Regeneron, which records net product sales in the U.S., while Bayer records sales outside the U.S. [7].

Company Overview - Kalaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing treatments for prevalent retinal diseases [3] - The company is currently developing TH103, a novel anti-VEGF investigational therapy designed to improve VEGF inhibition and retention in the retina [3] Product Development - TH103 is a fully humanized, recombinant fusion protein that acts as a decoy receptor against VEGF [3] - The therapy is currently undergoing a Phase 1 clinical trial for the treatment of neovascular Age-related Macular Degeneration (nAMD) [3] - Kalaris plans to expand the development of TH103 to treat additional retinal diseases, including Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO) [3] Upcoming Events - Kalaris management will participate in a Fireside Chat at the Stifel 2025 Virtual Ophthalmology Forum on May 27, 2025 [1][4] - The event will feature speakers Andrew Oxtoby, CEO, and Matthew Feinsod, CMO [4] - A replay of the event will be available on Kalaris Therapeutics' Investor Relations webpage following the event [2]

Core Viewpoint - Regeneron Pharmaceuticals has announced that the FDA has accepted the supplemental Biologics License Application for EYLEA HD, which could become the first treatment for retinal vein occlusion (RVO) allowing for dosing every 8 weeks after an initial monthly period, potentially reducing the number of injections required compared to existing therapies [1][2]. Group 1: EYLEA HD Overview - EYLEA HD is being developed for the treatment of macular edema following RVO and aims to provide greater dosing flexibility with options for monthly dosing across approved indications [1][2]. - The FDA's target action date for EYLEA HD is August 19, 2025, following the use of a Priority Review voucher [1]. Group 2: Clinical Trial Data - The QUASAR trial, a Phase 3 study, demonstrated that EYLEA HD administered every 8 weeks after initial monthly doses achieved non-inferior visual acuity gains compared to EYLEA dosed every 4 weeks [2][6]. - The safety profile of EYLEA HD was consistent with EYLEA, with increased ocular pressure being the only notable adverse event occurring in 5% of patients [3][4]. Group 3: Market Context - RVO is a significant cause of vision loss affecting over 28 million people globally, highlighting the need for effective treatment options [10]. - Anti-VEGF therapies, including EYLEA, are commonly used to treat macular edema due to RVO, with EYLEA HD aiming to improve treatment adherence through reduced injection frequency [8][11]. Group 4: Company Background - Regeneron has a strong history in developing treatments for serious eye diseases, with EYLEA having transformed the treatment landscape for various chorioretinal vascular diseases [11][12]. - The company collaborates with Bayer AG for the development and marketing of EYLEA HD outside the U.S., sharing profits from sales [13].