$24.000
-0.698 (-2.91%)收盘时
SGP 资讯
SGP 事件
SpyGlass Pharma Announces Bimatoprost Drug Trial Results
SpyGlass Pharma announced four-year first-in-human, or FIH, trial results for the Bimatoprost Drug Pad-IOL System, or BIM-IOL System, in patients with mild-to-moderate open angle glaucoma, or OAG, or ocular hypertension, or OHT, undergoing routine cataract surgery. SpyGlass Pharma designed the FIH trial to evaluate the safety and efficacy of the BIM-IOL System in patients for seven years. Interim safety and efficacy data in evaluable patients at the 4-year timepoint: 37% reduction in mean IOP across all three dose groups from 25.1 +/- 2.5 mmHg at baseline post-washout to 15.9 +/- 2.8 mmHg; 86% of patients remained off all topical IOP-lowering drops; 90% of patients maintained 20/25 BCDVA and no product-related adverse events were reported
SpyGlass Pharma Acquires Advanced Vision Science for Approximately $13M
SpyGlass Pharma announced the acquisition of all the outstanding shares of common stock of Advanced Vision Science for approximately $13M in cash. This acquisition secures scalable commercial IOL manufacturing capacity for SpyGlass Pharma. Under the agreement, AVS will be the exclusive manufacturer and supplier of several types of IOLs to Santen for commercialization in Japan. Additionally, AVS will continue to license its glistening-free hydrophobic acrylic lens material to Bausch + Lomb for use in the enVista IOL line, and manufacture products for other global IOL companies.
SpyGlass Pharma to Complete Phase 3 Trials for BIM-IOL System by 2027
"We are pleased to report that enrollment in our parallel Phase 3 registrational trials of the BIM-IOL System, which if approved by the US Food and Drug Administration, has the potential to serve the approximately one million annual cataract procedures in glaucoma and ocular hypertension patients, remains on track for completion in 2027. In parallel, SpyGlass remains diligently focused on initiating our first-in-human study of our next-generation BIM-DRS with the potential to provide lasting intraocular pressure reduction to every pseudophakic glaucoma patient, which would grow the addressable patient population substantially, in the second half of this year," stated Patrick Mooney, chief executive officer of SpyGlass Pharma. "Collectively, our BIM-IOL System and BIM-DRS hold the potential to provide long-term, drop-free glaucoma treatment and sustained visual protection."
SpyGlass Pharma Receives Approval for New CPT Code
SpyGlass Pharma announced that the American Medical Association's CPT Editorial Panel approved a new add-on Category III CPT code for attachment and insertion of intraocular lens prosthesis-mounted drug-eluting implant, based on the application submitted for the Bimatoprost Drug Pad-IOL System, in conjunction with established Category I cataract surgery procedure codes. "The approved Category III CPT code for attachment and insertion of the BIM-IOL System in conjunction with routine cataract surgery is an exciting moment in our path to product commercialization and reimbursement upon FDA approval," said Patrick Mooney, CEO of SpyGlass Pharma.
SpyGlass Pharma Reports Positive 12-Month Trial Results for BIM-IOL System
SpyGlass Pharma announced positive 12-month results from the Phase 1/2 trial evaluating its lead product candidate, the Bimatoprost Drug Pad-IOL System, BIM-IOL System, for the treatment of elevated intraocular pressure in patients previously diagnosed with open-angle glaucoma or ocular hypertension and a concomitant cataract. A total of 104 patients were randomized 2:1:1 to receive the 78 mcg BIM-IOL System and 39 mcg BIM-IOL System with daily administration of artificial tear drops, or a commercially available monofocal IOL from Alcon, Bausch + Lomb or Johnson & Johnson with twice-daily administration of timolol eye drops as the control group. At 12 months, the BIM-IOL System achieved: Evaluable patients achieved a 34% and 42% reduction in mean IOP from baseline in the 78-mcg and 39-mcg dose groups, respectively, compared to a 35% reduction in the control group at 8 a.m. Results were similar at the 10 a.m. timepoint. 98% of evaluable patients in the 78-mcg dose group and 96% of evaluable patients in the 39-mcg dose group were free from all topical IOP-lowering medications. Evaluable patients demonstrated vision improvement, 100% reaching 20/32 or better best corrected distance visual acuity and mean BCDVA of 86 letters. Adverse event rates were similar across the 78-mcg, 39-mcg, and control groups. No serious ocular AEs were observed
本页仅供研究参考，不构成投资建议。模型可能出错。过往表现不代表未来结果。