SpyGlass Pharma: Eye pressure falls 37% at four years
Four-year results included 86% of evaluable patients remaining off topical drops and 90% maintaining at least 20/25 visual acuity.
Sentiment and the balance of points
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Form Type
8-K
Rhea-AI Filing Summary
SpyGlass Pharma, Inc. reported interim four-year results for its Bimatoprost Drug Pad-IOL System in 21 evaluable patients with mild-to-moderate open-angle glaucoma or ocular hypertension undergoing routine cataract surgery. Mean intraocular pressure decreased 37% across all three dose groups, from 25.1 ± 2.5 mmHg at baseline post-washout to 15.9 ± 2.8 mmHg. Eighteen of 21 patients (86%) remained off topical IOP-lowering drops, 90% maintained at least 20/25 best corrected distance visual acuity, and no product-related adverse events were reported.
The trial enrolled 23 patients across 75 mcg, 150 mcg and 300 mcg dose groups and was designed to evaluate safety and efficacy for seven years. The first-in-human system is designed to deliver bimatoprost for up to seven years.
Filing Explained
The four-year data are from the first-in-human system, designed for up to seven years of delivery; the system in ongoing Phase 3 trials is designed for three years, so the release reports no four-year results for that Phase 3 design.
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Mean IOP reduction: 37%
Mean IOP at baseline post-washout: 25.1 ± 2.5 mmHg
Mean IOP at four years: 15.9 ± 2.8 mmHg
+5 more
8 metrics
Mean IOP reduction
37%
Across all three dose groups at the four-year timepoint.
Mean IOP at baseline post-washout
25.1 ± 2.5 mmHg
First-in-human trial.
Mean IOP at four years
15.9 ± 2.8 mmHg
Across all three dose groups.
Patients off topical IOP-lowering drops
18 of 21 patients (86%)
At the four-year timepoint.
Patients maintaining at least 20/25 BCDVA
90%
At the four-year timepoint.
Trial enrollment
23 patients
Sequentially assigned across three dosage groups.
Dosage groups
75 mcg, 150 mcg, and 300 mcg
First-in-human trial.
First-in-human system delivery design
Up to seven years
Designed to deliver bimatoprost.
Key Terms
intraocular pressure (IOP), best corrected distance visual acuity (BCDVA), non-bioerodible, 505(b)(2) New Drug Application (NDA), +1 more
5 terms
intraocular pressure (IOP) medical
"reduction in mean intraocular pressure (IOP) across all dose groups"
Intraocular pressure (IOP) is the fluid pressure inside the eye, like the air pressure inside a tire that keeps the eye’s shape and function stable. IOP matters to investors because persistently high pressure is the main risk factor for glaucoma and other vision problems, so IOP readings drive demand for medicines, devices and clinical trials, influence regulatory decisions, and can materially affect a healthcare company’s revenue outlook.
best corrected distance visual acuity (BCDVA) medical
"maintained ≥20/25 best corrected distance visual acuity (BCDVA)"
non-bioerodible technical
"novel, proprietary non-bioerodible drug pads attached to its intraocular lens"
A non-bioerodible material or medical device is one that does not break down, dissolve, or get absorbed by the body over time; it remains physically intact unless surgically removed. For investors, this matters because permanence affects product design, long-term safety monitoring, regulatory requirements, and market demand—similar to choosing a permanent metal fixture versus a temporary, dissolving patch in construction or home repair.
505(b)(2) New Drug Application (NDA) regulatory
"advance the program through 505(b)(2) New Drug Application (NDA) submission"
A 505(b)(2) new drug application is an FDA approval pathway that lets a company rely partly on existing clinical or published data instead of repeating every study, allowing development of drug changes like new formulations, dosages, or combinations. For investors it matters because this route can cut time and cost compared with a full new-drug program while still offering potential market exclusivity and commercial upside, but it carries regulatory and patent-risk trade-offs.
prostaglandin analog medical
"a prostaglandin analog approved for topical use"
A prostaglandin analog is a lab-made drug that mimics natural signaling molecules to change how tissues behave; most commonly it helps drain fluid from the eye to lower internal eye pressure used in treating glaucoma. Investors care because these drugs are often chronic therapies with predictable sales, subject to patent, regulatory approval, and competitive pressures—factors that affect revenue, pricing power, and long-term value in pharmaceutical portfolios.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did SGP's four-year BIM-IOL trial results show?
Mean IOP was reduced 37% across all three dose groups, from 25.1 ± 2.5 mmHg at baseline post-washout to 15.9 ± 2.8 mmHg. Eighteen of 21 patients (86%) remained off all topical IOP-lowering drops, 90% maintained at least 20/25 BCDVA, and no product-related adverse events were reported.
How many patients were enrolled in SGP's first-in-human trial, and what doses were tested?
The trial enrolled 23 patients, sequentially assigned 1:1:1 across three dosage groups: 75 mcg, 150 mcg, and 300 mcg. At the 48-month timepoint, 21 patients remained evaluable; before the 36-month visit, one patient moved outside the country and one patient was discontinued after receiving a cancer diagnosis.
How long is SGP's BIM-IOL System designed to deliver bimatoprost?
The system in the first-in-human trial is designed to deliver bimatoprost for up to seven years. The system being evaluated in ongoing Phase 3 clinical trials is designed to consistently deliver bimatoprost for three years.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 19, 2026
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
(Address of principal executive offices, including zip code)
(949 ) 284-6904
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 8.01. Other Events.
On October 19, 2026, SpyGlass Pharma, Inc. issued a press release providing positive interim 4-year data from its first-in-human trial of its Bimatoprost Drug Pad-IOL System. A copy of this press release is attached hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits.
Exhibit Number | Description | |||||||
99.1 | Press Release of SpyGlass Pharma, Inc., dated October 19, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
SPYGLASS PHARMA, INC. | |||||||||||
By: | /s/ Jean-Frédéric Viret, Ph.D. | ||||||||||
Jean-Frédéric Viret, Ph.D. | |||||||||||
Date: October 19, 2026 | Chief Financial Officer | ||||||||||
Exhibit 99.1
SpyGlass Pharma Announces Positive 4-Year Data From First-in-Human Trial of Its Innovative BIM-IOL System
Groundbreaking 4-year safety and efficacy results:
•37% reduction in mean intraocular pressure (IOP) across all dose groups
•86% of patients remained off all topical IOP-lowering drops
•90% of patients maintained ≥20/25 best corrected distance visual acuity (BCDVA)
•No product-related adverse events were reported
IRVINE, Calif., October 19, 2026 – SpyGlass Pharma, Inc. (Nasdaq: SGP) (“SpyGlass Pharma” or “Company”), a late-stage biopharmaceutical company dedicated to transforming the treatment paradigm for patients living with chronic eye conditions through long-acting, sustained drug delivery of approved medicines, today announced positive 4-year first-in-human (FIH) trial results for the Bimatoprost Drug Pad-IOL System (BIM-IOL System) in patients with mild-to-moderate open angle glaucoma (OAG) or ocular hypertension (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 (N=21) 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% (18 of 21) of patients remained off all topical IOP-lowering drops
•90% of patients maintained ≥20/25 BCDVA
•No product-related adverse events were reported
“Achieving four years of sustained IOP reduction, while largely eliminating the need for daily drops and maintaining a clear safety profile and excellent visual outcomes, establishes a new benchmark for durable, drop-free disease control,” said Paul Yoo, O.D., senior vice president of clinical development for SpyGlass Pharma. “We look forward to gathering further long-term safety and efficacy evidence as we follow these patients through 2029.”
“This is the first time a sustained drug delivery implant for glaucoma therapy has demonstrated durable safety and efficacy results for four years,” said Patrick Mooney, chief executive officer of SpyGlass Pharma. “These remarkable results further underscore the significant potential for the BIM-IOL System to change the treatment paradigm for glaucoma patients undergoing cataract surgery. There is a significant unmet need to address as there are approximately one million cataract procedures performed in the United States each year in patients with glaucoma. The BIM-IOL System is designed to fit directly into every cataract surgeon’s workflow to address two of the leading causes of preventable blindness in a single procedure: restoring vision from cataracts and lowering IOP to preserve a patient’s precious sight. We are incredibly proud of these results as they demonstrate the versatility of our drug delivery technology to provide clinically meaningful, enduring IOP control for patients.”
About the First-in-Human Trial
The FIH trial is a single-center, prospective trial evaluating the BIM-IOL System for the treatment of elevated IOP in patients with mild-to-moderate OAG or OHT undergoing routine cataract surgery. A total of 23 patients were sequentially assigned 1:1:1 across three dosage groups (75 mcg, 150 mcg and 300 mcg). The BIM-IOL System in the FIH trial is designed to deliver bimatoprost for up to 7 years. At the 48-month timepoint, 21 evaluable patients remained. Prior to the 36-month visit, one patient moved outside the country and one patient was discontinued after receiving a cancer diagnosis.
About the Bimatoprost Drug Pad-IOL System
SpyGlass Pharma’s lead product candidate, the BIM-IOL System, comprising novel, proprietary non-bioerodible drug pads attached to its intraocular lens, was designed to be implanted during routine cataract surgery to reduce elevated IOP in patients who have either OAG or OHT. The BIM-IOL System being evaluated in ongoing Phase 3 clinical trials is designed to consistently deliver 3 years of bimatoprost, a prostaglandin analog approved for topical use by the U.S. Food and Drug Administration (FDA) in 2001, for the reduction of elevated IOP in patients with OAG or OHT.
The Company continues long-term follow-up of patients in both the FIH trial and Phase 1/2 trial as well as patient enrollment in ongoing Phase 3 clinical trials. SpyGlass Pharma plans to work with the FDA to advance the program through 505(b)(2) New Drug Application (NDA) submission and ultimately to potential commercial approval.
About SpyGlass Pharma
SpyGlass Pharma is a late-stage biopharmaceutical company dedicated to transforming the treatment paradigm for patients living with chronic eye conditions through long-acting, sustained drug delivery of approved medicines. The Company’s mission is to significantly improve the lives of patients with chronic eye conditions by developing durable drug delivery solutions that can empower patients and surgeons with confidence in long-term disease control and vision preservation.
The SpyGlass Pharma platform, a novel, non-bioerodible drug delivery technology, is designed to be used with various well-established, approved medicines, including bimatoprost and other small molecules, providing flexibility to potentially treat a range of conditions in the front and back of the eye.
The Company was founded in 2019 by Malik Y. Kahook, M.D. and Glenn Sussman to solve the lack of ophthalmic innovations that capitalize on durable treatment options. The SpyGlass Pharma platform was originally developed in the Sue Anschutz-Rodgers Eye Center at the University of Colorado Anschutz School of Medicine.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The terms "lasting," "long-term," and "enduring" refer to being able to control IOP for years with one procedure compared to current eye drops, which require dosing daily or even more frequently. All statements in this press release that are not purely historical are forward-looking statements, including, but not limited to, statements regarding: the potential benefits and impact of the BIM-IOL System on patients, anticipated follow-up and presentation of additional data, and SpyGlass Pharma’s plans relating to the clinical development of the BIM-IOL System towards commercial approval. The forward-looking statements contained herein are based upon SpyGlass Pharma’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including those set forth in the Risk Factors section of the Company’s Quarterly Report on Form 10-Q for the three and six months ended June 30, 2026, filed with the Securities and Exchange Commission on August 6, 2026, and the other documents that SpyGlass Pharma may file from time to time with the SEC. These forward-looking statements are made as of the date of this press release, and SpyGlass Pharma assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Media Contact:
Nami Surendranath
(402) 507-6757
Nami Surendranath
(402) 507-6757
nami.surendranath@omc.com
Investor Contact:
Ami Bavishi or Nick Colangelo
Gilmartin Group LLC
investors@spyglasspharma.com