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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
US Stocks Drop Amid Middle East Tensions; Trump Announces Maritime Trade Security Measures
The major averages closed broadly lower amid widening hostilities in the Middle East, but came off their earlier lows after President Donald Trump stated in a Truth Social post that he has ordered the Development Finance Corporation to provide political risk insurance and guarantees for the financial security of maritime trade through the Gulf, adding that the U.S. Navy will begin escorting tankers through the Strait of Hormuz, if needed.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Targetreportedand provided guidance for Q1 and FY26Best Buyreportedand increased its quarterly dividendMongoDBreported better-than-expected Q4 earnings and revenue butPinterestannounced afrom Elliott Investment Management, saying it expects to use the proceeds to repurchase sharesAppleannounced awith the M5 chip and announced new M5 Pro and M5 Max chips2. WALL STREET CALLS:Blockto Buy at HSBCMongoDBto Neutral at BairdPalo Alto Networksto Buy from Sell at AreteuniQurereceived two more, from Wells Fargo and Mizuho, after the company said the FDA "strongly recommended" a new Huntington's disease studyWall Streetof recent IPOs Once Upon a Farmand SpyGlass Pharma3. AROUND THE WEB:Verizonconsidered pulling back on its NFL sponsorship deal, WSJ reportsSenate Democrats are preparing legislation that would break up U.S. meatpacking cocmccpanies, WSJ saysMetawill form a new applied AI engineering group in its Reality Labs division, WSJ reportsFederal Communications Commission, FCC, chair Brendan Carr has signaled the watchdog does not plan to block Paramount's$110B deal to buy Warner Bros, FT saysDF Research, representing the opinions of Keith Dalrymple and Dalrymple Finance, issued a cautious note on WillScot4. MOVERS:Battalion Oilgains afterto raise approximately $15M at a price of $5.50 per shareZiff Davishigher after entering aits Connectivity division to Accenturefor $1.2B in cashPlug Powerincreases after appointingTheravance Biopharmafalls after announcing it will wind down itsThredUPlower afterand providing guidance for FY265. EARNINGS/GUIDANCE:Upload Softwareand provided guidance for Q1 and FY26Antalpha, with CFO Paul Liang commenting that the company "finished 2025 on a solid footing"Paysafe, with EPS beating consensusCignabacked itsas it announced a change in CEOOn Holdingand provided guidance for FY26INDEXES:The Dow fell 403.51, or 0.83%, to 48,501.27, the Nasdaq lost 232.17, or 1.02%, to 22,516.69, and the S&P 500 declined 64.99, or 0.94%, to 6,816.93.
Middle East Conflict Escalates, Major Indices Down Nearly 1.5%
The three top indexes were each down nearly 1.5% near noon following fresh military strikes and widening hostilities in the Middle East, triggering concerns about prolonged conflict and its potential to disrupt global energy markets. Iran's Strait of Hormuz, the globe's most vital transit route for crude oil, has been closed, with Reuters reporting that the Iranian Revolutionary Guard commander said Iran would set ablaze ships attempting to pass through the strait. Oil prices are up about 4% at midday following the news, while gold prices are dropping nearly 5% as the commodity sees continued volatility.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Targetreportedand provided guidance for Q1 and FY26Best Buyreportedand increased its quarterly dividendMongoDBreported better-than-expected Q4 earnings and revenue butPinterestannounced afrom Elliott Investment Management, saying it expects to use the proceeds to repurchase sharesAppleannounced aand announced new M5 Pro and M5 Max chips2. WALL STREET CALLS:Blockto Buy at HSBCMongoDBto Neutral at BairdPalo Alto Networksto Buy from Sell at AreteuniQurereceived, from Wells Fargo and Mizuho, after the company said the FDA "strongly recommended" a new Huntington's disease studyWall Streetof recent IPOs Once Upon a Farmand SpyGlass Pharma3. AROUND THE WEB:Federal Communications Commission, FCC, chair Brendan Carr has signaled the watchdog does not plan to block Paramount's$110B deal to buy Warner Bros, FT saysA Waymorobotaxi briefly blocked an ambulance near the scene of a mass shooting in Austin while en route to pick up a passenger, an incident confirmed by both Waymo and EMS officials, Axios reportsHims'pharmacy partner will reintroduce a compounded pill version of GLP-1 drug Wegovy that was pulled from the market last month, Endpoints News saysDF Research, representing the opinions of Keith Dalrymple and Dalrymple Finance, issued a cautious note on WillScotU.S. officials are weighing imposing caps on the number of H200 chips Nvidiacan export to any single Chinese company, Bloomberg says4. MOVERS:Battalion Oilgains after entering into a definitive agreement toat a price of $5.50 per shareZiff Davishigher after entering aits Connectivity division to Accenturefor $1.2B in cashPlug Powerincreases after appointingTheravance Biopharmafalls after announcing it willprogram after Phase 3 resultsThredUPlower afterand providing guidance for FY265. EARNINGS/GUIDANCEUpload Softwareand provided guidance for Q1 and FY26Antalpha, with CFO Paul Liang commenting that the company "finished 2025 on a solid footing"Paysafe, with EPS beating consensusCignafor FY26 as it announced a change in CEOOn Holdingand provided guidance for FY26INDEXES:Near midday, the Dow was down 1.45%, or 710.52, to 48,194.26, the Nasdaq was down 1.38%, or 313.63, to 22,435.23, and the S&P 500 was down 1.35%, or 91.83, to 6,788.43.
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