$164.840
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GKOS 资讯
GKOS 事件
Glaukos Reports Significant Results for iDose TR in Phase 4 Trial
Glaukos announced topline results from the Phase 4 prospective, randomized, controlled clinical trial evaluating iDose TR administered in conjunction with cataract surgery compared to cataract surgery alone in patients with open-angle glaucoma, OAG, or ocular hypertension, OHT. The study achieved its primary efficacy endpoint, with iDose TR demonstrating statistically significant superiority in the reduction of mean diurnal intraocular pressure, IOP, when administered in conjunction with cataract surgery compared to cataract surgery alone. At month 3, subjects undergoing cataract surgery and administration of iDose TR achieved a mean diurnal IOP reduction of 11.1 mmHg from baseline, compared to 7.4 mmHg for subjects undergoing cataract surgery alone, demonstrating statistically significant superiority with a clinically meaningful incremental treatment effect of 3.6 mmHg. In addition, iDose TR demonstrated statistically significant superiority across all pre-specified secondary responder analyses, further supporting the consistency and robustness of the treatment effect observed in the study.
Glaukos Shares Down 7.4% to $159.49
Glaukos is down -7.4%, or -$12.69 to $159.49.
Glaukos Signs Exclusive License Agreement with RevOpsis for RO-104 Development
Glaukos announced an exclusive license agreement with RevOpsis Therapeutics to develop and commercialize RO-104, a novel tri-specific biologic for the treatment of neovascular age-related macular degeneration, nAMD, diabetic macula edema, DME, diabetic retinopathy, DR, and retinal vein occlusion, RVO. The agreement also grants Glaukos exclusive rights to RevOpsis' proprietary RevMod platform in geographic atrophy, DME, DR, RVO, and nAMD for the discovery and development of up to four additional next-generation retinal biologic candidates. "The addition of RO-104 and exclusive access to the proprietary RevMod platform in the field of retina represents an important strategic step in the continued expansion of our retinal franchise and is highly complementary to our ongoing retinal R&D initiatives," said Thomas Burns, Glaukos chairman and chief executive officer. "This licensing agreement adds a first-in-class, tri-specific biologic to strengthen our retina pipeline and provides a differentiated discovery engine with the potential to generate several additional retinal therapeutic candidates across a variety of retinal diseases."
Glaukos Epioxa Study Shows Long-Term Efficacy
Glaukos announced positive topline results from a long-term Phase 3 extension study evaluating the durability, visual outcomes, and safety of Epioxa, the company's groundbreaking epi-on corneal cross-linking therapy for the treatment of keratoconus, a sight-threatening corneal disease that remains significantly undiagnosed and undertreated. The extension study followed a cohort of patients for three years after cross-linking treatment in Epioxa's second Phase 3 pivotal trial. The long-term follow-up results demonstrated durable efficacy and a favorable long-term safety profile through three years following a single Epioxa treatment, with no additional intervention during the extension period. Treated eyes achieved a sustained 1.9 diopter (D) improvement in maximum corneal curvature (Kmax) from baseline, reflecting meaningful long-term corneal flattening and stabilization. Treated eyes also demonstrated clinically meaningful visual outcomes at year 3, with 29% and 20% of eyes gaining two or more and three or more lines of best-corrected visual acuity from baseline, respectively. The durability of these findings further supports Epioxa's potential to provide long-term disease stabilization following a single treatment. In addition, treated eyes maintained a favorable long-term safety profile through three years, with no serious adverse events, treatment-related adverse events, or discontinuations due to adverse events. "These long-term results further reinforce the potential of Epioxa to provide durable clinical benefits for patients living with keratoconus," said Thomas Burns, chairman and chief executive officer of Glaukos. "The sustained improvements in corneal shape and visual acuity, coupled with an excellent long-term safety profile, reinforce our view that Epioxa represents a transformative treatment advancement for keratoconus patients."
Major US Indices Close Lower, Semiconductor Stocks Plummet
All major US indices finished the day at the lows and even a less hawkish than feared FOMC decision failed to backstop the AI capex trade gone awry. Tech and Industrials were the worst performing sectors in the S&P500 as Semiconductors, Semi Equipment, and Hardware names continued to unravel with massive drawdowns. Micronfell another 10% while KLA Corp- which reported results overnight - was down 11%. Among notable Industrials, Lennox Internationalfell over 20% despite a Q2 earnings beat as its management cut earnings guidance for the year. The sparse positive column once again featured Consumer Staples, with Walmartnow having risen for 4 consecutive sessions.In the opening hour of the evening session, equity futures are modestly higher - S&P e-minis are up 0.4%, Nasdaq 100 is up 0.6%, and Dow Industrials are up 0.3%. Investors are still digesting today's FOMC decision to keep rates intact with mostly unchanged accompanying statement while also watching diverging price action from Microsoftand Metaafter their earnings reports and updates on spending plans.Check out this evening's top movers from around Wall Street, compiled by The Fly.HIGHER AFTER EARNINGSSilicon Motion Technologyup 10.6%Fortinetup 10.5%FormFactorup 10.4%Glaukosup 8.7%Microsoftup 8.6%Lam Researchup 6.1%Chipotle Mexican Grillup 5.9%GFL Environmentalup 5.7%Pitney Bowesup 5.2%Starbucksup 4.9%Everforthup 4.7%ALSO HIGHERFive9up 7.1% after admission into S&P SmallCap 600 indexDOWN AFTER EARNINGSFair Isaacdown 9.3%Carvanadown 7.7%Houlihan Lokeydown 6.9%Meta Platformsdown 6.5%Arm Holdingsdown 6.1%Align Technologydown 6.1%QUALCOMMdown 3.6%Robinhood Marketsdown 1.0%
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