Opthea Ltd. is a clinical stage biopharmaceutical company, which engages in the development of biological therapeutics for the treatment of progressive retinal diseases. It focuses on treating neovascular age-related macular degeneration and diabetic macular edema, which causes visual impairment among elderly and diabetic patients. The company was founded on October 17, 1984, and is headquartered in South Yarra, Australia.
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- Qlaris Bio appointed Fred Guerard, PharmD, as president and CEO, succeeding cofounder Thurein Htoo as the company prepares for Phase 3 trials. - QLS-111, a novel eye drop targeting episcleral venous pressure, demonstrated sustained intraocular pressure reduction with favorable safety in Phase 2 trials. - Guerard brings over two decades of global ophthalmology leadership experience from Opthea, Graybug Vision, and Novartis to advance the glaucoma therapy. - The appointment positions Qlaris for late-stage development and potential commercialization of its first-in-class glaucoma treatment.
- Invex Therapeutics has been granted an FDA meeting to discuss the development pathway for Presendin, a repurposed diabetes drug being tested for idiopathic intracranial hypertension (IIH). - The company's IIH EVOLVE phase III trial will enroll 240 newly diagnosed patients across 37 centers in Europe, UK, Australia, and the US to assess intracranial pressure reduction. - Previous phase II results demonstrated statistically significant reduction in key endpoints related to intracranial pressure, supporting progression to phase III development. - IIH is a rapidly growing orphan indication with patient numbers increasing by more than 350% over the last 10 years, primarily affecting obese women of childbearing age.
- Biotech company Opthea's eye treatment clinical trial has failed, potentially forcing the company to repay over $1 billion in development funding and threatening its survival. - Phil King's Regal Partners, holding a 30% stake as Opthea's largest shareholder, faces a potential $220 million reduction in funds under management if the company collapses. - The negative trial results have already impacted Regal Partners' stock, which dropped 16% on Monday, while Opthea's shares had previously declined 22% this year amid increasing short interest.
- Several ASX-listed biotech companies are anticipating crucial Phase III clinical trial results in 2025, which could significantly impact their market value and future prospects. - Dimerix expects results from its ACTION3 Phase III trial of DMX-200 for focal segmental glomerulosclerosis (FSGS) by mid-2025, a rare kidney condition with no approved treatments. - Opthea anticipates Phase III trial results for sozinibercept (OPT-302) in combination with aflibercept or ranibizumab for wet age-related macular degeneration (wet-AMD) in 2025. - Recce Pharmaceuticals is set to commence a Phase III trial in Indonesia for RECCE 327 as a topical gel to treat diabetic foot infections (DFI) in early 2025.
• Alkeus Pharmaceuticals shared results from TEASE studies, showing that gildeuretinol (ALK-001) significantly reduced the growth rate of retinal atrophic lesions in Stargardt disease patients. • Annexon presented data from the Phase 2 ARCHER trial, indicating that ANX007 provides significant vision protection and photoreceptor preservation in dry AMD patients with geographic atrophy. • Opthea highlighted sozinibercept, currently in Phase 3 trials, as a potential therapy to enhance vision acuity gains in wet AMD when combined with anti-VEGF-A agents.
- Opthea Limited has completed the final patient visit for the Phase 3 COAST trial of sozinibercept in combination with aflibercept for wet AMD. - Topline results from the COAST trial are anticipated in early Q2 CY25, with the ShORe trial results expected in mid-CY25. - Sozinibercept, a VEGF-C/D inhibitor, is being evaluated for its potential to improve visual outcomes in wet AMD patients when combined with anti-VEGF-A therapies. - The FDA has granted Fast Track Designation to sozinibercept, highlighting its potential to address an unmet need in wet AMD treatment.
- Sozinibercept, a novel VEGF-C/D inhibitor, is under investigation for neovascular age-related macular degeneration (nAMD) to improve visual acuity beyond current VEGF-A therapies. - Phase 2b trials showed that sozinibercept combined with ranibizumab led to a statistically significant additional gain of 3.4 letters in BCVA compared to ranibizumab alone at 24 weeks. - Ongoing Phase 3 trials (ShORe and COAST) are evaluating sozinibercept in combination with ranibizumab or aflibercept, with potential regulatory filings planned after 12-month efficacy analysis. - Next-generation nAMD therapies like sozinibercept aim to target multiple pathways beyond VEGF-A to enhance vision and quality of life for patients, addressing the limitations of current treatments.
