Age-related Macular Degeneration

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InMed Reports Third Quarter Fiscal 2025 Financial Results and Provides Business Update
Newsfile· 2025-05-12 22:00
Core Viewpoint - InMed Pharmaceuticals reported its financial results for the third quarter of fiscal year 2025, highlighting advancements in its drug development pipeline, particularly INM-901 for Alzheimer's disease and INM-089 for dry age-related macular degeneration, while also addressing financial performance and operational challenges [1][2]. Financial Performance - For the three months ended March 31, 2025, InMed reported a net loss of $2.12 million, an increase from a net loss of $1.72 million in the same period the previous year, primarily due to higher research and development expenses [6][9]. - General and administrative expenses decreased to $1.33 million from $3.75 million year-over-year, attributed to lower accounting fees and share-based payments [10]. - As of March 31, 2025, the company's cash, cash equivalents, and short-term investments totaled $4.68 million, down from $6.57 million at June 30, 2024, indicating a need for additional funding sources [11]. Revenue Generation - BayMedica's commercial business generated revenues of $1.26 million for the three months ended March 31, 2025, reflecting an 8% increase from $1.18 million in the same period last year, driven by expanded marketing efforts and increased demand for cannabinoid products [12]. - Despite stable revenues, gross margins declined due to competitive pricing pressures and increased sales of lower-margin products [12]. Drug Development Updates - INM-901 is under development for Alzheimer's disease, targeting neuroinflammation through multiple biological pathways, with positive preclinical data indicating its potential to significantly reduce neuroinflammation [3][4]. - INM-089 is being developed for dry age-related macular degeneration, showing promise in preserving retinal function and improving retinal structure in preclinical studies [6][8]. Future Outlook - The company expects its cash reserves to be sufficient to fund operations into the third quarter of calendar year 2025, contingent on the timing of commercial revenues and operating expenses [11]. - InMed plans to seek additional funding through equity and debt financings, collaborations, and other strategic transactions to support its pharmaceutical pipeline [11].
Astellas to Present New Data in Geographic Atrophy at Upcoming Ophthalmology Annual Congresses
Prnewswire· 2025-05-01 13:00
Core Insights - Astellas Pharma Inc. will present new data on IZERVAY™ (avacincaptad pegol intravitreal solution) at the ARVO and RWC meetings, focusing on geographic atrophy (GA) and patient experiences [1][2][3] Group 1: Presentation Details - The data includes nine abstracts, with two oral presentations, analyzing biomarkers, patient experiences, and mechanisms of disease from the GATHER Phase 3 studies of IZERVAY for GA secondary to age-related macular degeneration (AMD) [2][3] - Key presentations at the 2025 ARVO Annual Meeting include topics on the association of baseline central subfield ellipsoid zone integrity with visual acuity and future vision loss, and understanding the experience of people living with GA in various countries [3][4][6] Group 2: Research Highlights - Research highlights include multiple posters evaluating imaging data from the GATHER1 and GATHER2 studies, linking structure and function in GA, and preclinical posters refining the mechanism of action of avacincaptad pegol [4][5] - Qualitative studies assess the impact of GA symptoms on health-related quality of life (HRQoL) and coping mechanisms used by patients in the U.S., Spain, Germany, and France [4][5] Group 3: Clinical Trials - The GATHER clinical trials demonstrated that IZERVAY met its primary endpoint, with GATHER1 enrolling 286 participants and GATHER2 enrolling 448 participants, evaluating the safety and efficacy of monthly 2 mg intravitreal administration [15][17] - In year 2 of the GATHER2 study, patients previously treated with IZERVAY were re-randomized to receive either monthly or every other month dosing, while those who received sham continued with sham treatment [18]
Opthea Reports Half Year Results and Business Updates
Newsfilter· 2025-02-28 12:00
Core Viewpoint - Opthea Limited is progressing towards delivering innovative therapies for wet age-related macular degeneration (wet AMD), with significant advancements expected in its clinical trials and financial management [2][3]. Financial Results and Highlights - For the six months ended December 31, 2024, Opthea reported a net loss of US$131.9 million, an increase from US$101.7 million in the same period of 2023, primarily due to fair value losses on investor options and interest expenses [5][23]. - Cash and cash equivalents stood at US$131.9 million as of December 31, 2024, with a cash runway expected to extend through the anticipated topline data readouts of the Phase 3 trials COAST and ShORe [2][5]. - Net cash flows used in operating activities were US$72.6 million, compared to US$69.4 million in the prior year [5]. Clinical Development Program - Opthea is conducting two pivotal Phase 3 clinical trials, COAST and ShORe, aimed at evaluating the efficacy of sozinibercept in combination with standard anti-VEGF-A therapies for wet AMD [9][14]. - Topline results from the COAST trial are expected in early Q2 CY2025, while results from the ShORe trial are anticipated in mid-CY2025 [6][9]. - Sozinibercept has received Fast Track Designation from the US FDA, indicating its potential to address significant unmet medical needs in wet AMD [9]. Product Overview - Sozinibercept is a first-in-class VEGF-C/D 'trap' inhibitor designed to improve vision in wet AMD patients, potentially becoming the first therapy in nearly 20 years to demonstrate superior visual outcomes [8][14]. - The drug targets the inhibition of VEGF-C and VEGF-D, which are known to contribute to retinal diseases, thereby preventing blood vessel growth and vascular leakage [8]. Corporate Highlights - Recent corporate developments include the appointment of new executives and the completion of a significant capital raising initiative totaling approximately A$227.3 million (US$150 million) [6][9]. - Opthea joined the S&P/ASX 300 Index in September 2024, reflecting its growing market presence [6].