Spyglass Pharma (SGP) FDA Approvals $21.20 -1.04 (-4.68%) Closing price 04:00 PM EasternExtended Trading$21.20 +0.00 (+0.02%) As of 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock Spyglass Pharma's Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Spyglass Pharma (SGP). Over the past two years, Spyglass Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Bimatoprost. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Bimatoprost FDA Regulatory Events Bimatoprost is a drug developed by Spyglass Pharma for the following indication: in patients previously diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Positive Results - March 9,2026Positive Results Phase 1/2Drug: BimatoprostAnnounced Date: March 9, 2026Indication: in patients previously diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract.AnnouncementSpyGlass Pharma, Inc.AI SummarySpyGlass Pharma reported positive 12‑month results for its Bimatoprost Drug Pad‑IOL System (BIM‑IOL) to treat elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension who also had cataracts. In a randomized Phase 1/2 study of 104 patients, two BIM‑IOL dose groups were compared with a standard monofocal IOL plus timolol drops. At 12 months, 97% of BIM‑IOL patients were off all topical IOP‑lowering therapy. Visual outcomes were strong: 100% achieved 20/32 or better best‑corrected distance visual acuity and the mean BCDVA was equivalent to 20/20. Overall safety was comparable to routine cataract surgery. SpyGlass has begun two registrational Phase 3 trials of the 78‑mcg dose and continues long‑term follow‑up and enrollment. The company plans a 505(b)(2) pathway toward regulatory submission. Its non‑bioerodible delivery platform can carry bimatoprost and other small molecules, offering a durable treatment option for front and back of the eye. Read Announcement Spyglass Pharma FDA Events - Frequently Asked Questions Has Spyglass Pharma received FDA approval? As of now, Spyglass Pharma (SGP) has not received any FDA approvals for its therapy in the last two years. What drugs has Spyglass Pharma submitted to the FDA? In the past two years, Spyglass Pharma (SGP) has reported FDA regulatory activity for Bimatoprost. What is the most recent FDA event for Spyglass Pharma? The most recent FDA-related event for Spyglass Pharma occurred on March 9, 2026, involving Bimatoprost. The update was categorized as "Positive Results," with the company reporting: "SpyGlass Pharma, Inc." What conditions do Spyglass Pharma's current drugs treat? Currently, Spyglass Pharma has one therapy (Bimatoprost) targeting the following condition: in patients previously diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract.. 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FDA EventsBeam Therapeutics FDA EventsBioVie FDA EventsBioMarin Pharmaceutical FDA EventsCullinan Therapeutics FDA EventsDare Bioscience FDA EventsDesign Therapeutics FDA EventsDogwood Therapeutics FDA EventsEnlivex Therapeutics FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Soleno Therapeutics FDA Events TransMedics Group FDA Events AxoGen FDA Events NovoCure FDA Events PROCEPT BioRobotics FDA Events Pulse Biosciences FDA Events Inspire Medical Systems FDA Events Artivion FDA Events iRadimed FDA Events Alpha Tau Medical FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:SGP last updated on 3/9/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data. 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Positive Results - March 9,2026Positive Results Phase 1/2Drug: BimatoprostAnnounced Date: March 9, 2026Indication: in patients previously diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract.AnnouncementSpyGlass Pharma, Inc.AI SummarySpyGlass Pharma reported positive 12‑month results for its Bimatoprost Drug Pad‑IOL System (BIM‑IOL) to treat elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension who also had cataracts. In a randomized Phase 1/2 study of 104 patients, two BIM‑IOL dose groups were compared with a standard monofocal IOL plus timolol drops. At 12 months, 97% of BIM‑IOL patients were off all topical IOP‑lowering therapy. Visual outcomes were strong: 100% achieved 20/32 or better best‑corrected distance visual acuity and the mean BCDVA was equivalent to 20/20. Overall safety was comparable to routine cataract surgery. SpyGlass has begun two registrational Phase 3 trials of the 78‑mcg dose and continues long‑term follow‑up and enrollment. The company plans a 505(b)(2) pathway toward regulatory submission. Its non‑bioerodible delivery platform can carry bimatoprost and other small molecules, offering a durable treatment option for front and back of the eye. Read Announcement
