SpyGlass Pharma Announces Positive Topline 12-Month Phase 1/2 Trial Results for Its Innovative BIM-IOL System

Rhea-AI Summary

SpyGlass Pharma (NASDAQ: SGP) announced positive topline 12-month Phase 1/2 results for the BIM-IOL System on March 9, 2026. In 104 randomized patients (2:1:1), the 78-mcg and 39-mcg groups showed 34% and 42% mean IOP reductions at 8 a.m., versus 35% for control.

At 12 months 98% (78-mcg) and 96% (39-mcg) of evaluable patients were free of topical IOP medications; 100% achieved 20/32 or better BCDVA with mean BCDVA of 86 letters (≈20/20). AE rates were similar across arms; no serious ocular AEs. Two pivotal Phase 3 trials began randomizing in January 2026.

Positive

• 98% off topical IOP meds (78-mcg) at 12 months
• 96% off topical IOP meds (39-mcg) at 12 months
• Mean IOP reduction 34% (78-mcg) and 42% (39-mcg) at 8 a.m.
• 100% reached 20/32 or better BCDVA; mean 86 letters (≈20/20)
• Two registrational Phase 3 trials initiated January 2026

Negative

• Adverse event rates 41.2% (78-mcg) and 43.5% (39-mcg) versus 36.7% control

News Market Reaction – SGP

+1.65%

4 alerts

+1.65% Session close to close

+3.8% Peak Tracked

$959.87M Market Cap

0.7x Rel. Volume

In the Mar 9 session, SGP gained 1.65%, reflecting a mild positive market reaction. Argus tracked a peak move of +3.8% during that session. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights encouraging 12‑month Phase 1/2 results for the BIM‑IOL System, showing ...

Analysis

This announcement highlights encouraging 12‑month Phase 1/2 results for the BIM‑IOL System, showing meaningful intraocular pressure reductions and high-quality vision outcomes with medication-free rates above 95%. For a stock trading below its $27.81 200‑day MA and 17.76% under its 52‑week high, these data mark an important early efficacy and safety milestone. Investors may watch how pivotal Phase 3 enrollment progresses, future readouts, and any additional safety details as key drivers of the longer-term fundamental story.

Key Figures

Medication-free patients: 97% High-quality vision: 100% Trial size: 104 patients +5 more

8 metrics

Medication-free patients 97% BIM-IOL System patients off all topical IOP-lowering therapy at 12 months

High-quality vision 100% BIM-IOL patients with 20/32 or better BCDVA; mean BCDVA ~20/20

Trial size 104 patients Phase 1/2 trial randomized 2:1:1 to two BIM-IOL doses vs control

IOP reduction 34% & 42% vs 35% Mean IOP reduction at 12 months for 78 mcg, 39 mcg vs control at 8 a.m.

Med-free by dose 98% & 96% Evaluable 78 mcg and 39 mcg groups free from topical IOP meds

Visual acuity letters 86 letters Mean BCDVA (equivalent to 20/20 vision) in evaluable patients (N=72)

Adverse event rates 41.2%, 43.5%, 36.7% AE rates in 78 mcg, 39 mcg, and control groups, respectively

Dose arms 78 mcg (N=51), 39 mcg (N=23), control (N=30) Randomization breakdown of Phase 1/2 trial

Historical Context

2 past events · Latest: Mar 04 (Neutral)

Pattern 2 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 04	Investor conference	Neutral	-0.3%	Participation in Jefferies Biotech on the Bay investor meetings announced.
Feb 09	IPO completion	Positive	+6.3%	IPO closing with full over-allotment exercise and $172.5M gross proceeds.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Limited history since IPO shows modest moves on non-fundamental events and a stronger positive move on the IPO itself.

Recent Company History

Recent news for SpyGlass Pharma has focused on capital markets and investor engagement. The IPO closing on Feb 9, 2026 raised $172.5 million at $16.00 per share and saw a 6.3% next-day move. A later conference participation announcement on Mar 4, 2026 had a marginal -0.26% reaction. Against this backdrop, today’s Phase 1/2 topline results represent the first major clinical efficacy and safety update in the dataset.

Key Terms

phase 1/2 trial, phase 3 trials, intraocular pressure, open-angle glaucoma, +4 more

8 terms

phase 1/2 trial medical

"positive 12-month results from the Phase 1/2 trial evaluating its lead product"

A phase 1/2 trial combines the earliest human safety testing with an initial look at whether a treatment works, typically starting by checking tolerability and side effects and then expanding to measure early signs of benefit and the best dose. For investors, results from these trials are an early indicator of a drug’s clinical promise and regulatory path: positive data can materially increase a company’s value and reduce development risk, while negative data can sharply lower expectations.

phase 3 trials medical

"advancing enrollment for our two pivotal Phase 3 trials of the BIM-IOL System"

Phase 3 trials are the large-scale stage of testing for a new medical treatment or vaccine where the goal is to confirm effectiveness, monitor side effects, and compare it to existing options across hundreds to thousands of people. For investors, these trials are like a final dress rehearsal: their success or failure is the most powerful signal of whether a product can win regulatory approval, reach the market, and support future revenue, so results often drive stock value sharply.

intraocular pressure medical

"for the treatment of elevated intraocular pressure (IOP) in patients"

Intraocular pressure is the fluid pressure inside the eye, similar to the air pressure in a tire or the tension in a water balloon that helps the eye keep its shape. It matters to investors because sustained high pressure can lead to glaucoma and vision loss, driving demand for drugs, surgical devices, diagnostics and related regulatory approvals and reimbursements, which directly affect company revenues and risk profiles.

open-angle glaucoma medical

"patients previously diagnosed with open-angle glaucoma (OAG) or ocular hypertension"

A common, chronic eye disease in which fluid drains less efficiently from the eye, causing pressure to build and slowly damage the optic nerve; left untreated it typically produces gradual loss of peripheral vision. For investors, it matters because the condition drives demand for medications, surgical devices and diagnostic tests, influences regulatory approvals and reimbursement decisions, and affects long-term market size much like a steadily growing need for maintenance in an aging system.

ocular hypertension medical

"open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract"

Ocular hypertension is when the fluid pressure inside the eye is higher than normal without current damage to the optic nerve or measurable vision loss; think of it like high water pressure in a pipe that increases the chance of future leaks. It matters to investors because it represents a large at‑risk patient group and a potential market for drugs, eye drops, diagnostic tools and procedures aimed at lowering pressure and preventing progression to glaucoma.

best corrected distance visual acuity medical

"100% reaching 20/32 or better best corrected distance visual acuity (BCDVA)"

Best corrected distance visual acuity measures how well a person can see objects far away when wearing their optimal prescription lenses or after any corrective procedure. Think of it as a final test score for long‑range vision—like checking how clearly a telescope shows distant details after it's been precisely focused. For investors, it matters because changes in this measure are a key, objective way regulators and clinicians judge the effectiveness of eye treatments, devices, or drugs that claim to improve vision.

adverse event medical

"Adverse event (AE) rates were similar across the 78-mcg, 39-mcg, and control groups"

An adverse event is any unwanted or harmful medical occurrence experienced by a person during a clinical trial or after using a product, whether or not it is caused by the treatment. Investors watch these reports because they can signal safety problems that delay approvals, trigger additional testing, reduce sales, or harm a company’s reputation — similar to how a series of car breakdowns can cut value and future sales for an automaker.

randomized, controlled clinical trial medical

"multicenter, randomized, controlled clinical trial reinforce our previously released"

A randomized, controlled clinical trial is a study where participants are randomly assigned to receive either the treatment being tested or a comparison (a standard treatment or placebo), and outcomes are measured to see which works better. Think of it like flipping a coin to place people into two kitchens testing different recipes so the cook’s skill or patient differences don’t bias the result; for investors, these trials provide the most reliable evidence about a drug or device’s effectiveness and safety, which strongly affects regulatory approval, market potential, and investment risk.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 97% of patients who received the BIM-IOL System off all topical IOP-lowering therapy at 12-months
• 100% of BIM-IOL System patients achieved 20/32 or better BCDVA and a mean BCDVA equivalent to 20/20 vision, demonstrating high quality of vision, performance in line with the state-of-the-art IOLs in the control group
• Overall safety results were comparable to routine cataract surgery
  
  

ALISO VIEJO, Calif., March 09, 2026 (GLOBE NEWSWIRE) -- SpyGlass Pharma, Inc. (Nasdaq: SGP) (SpyGlass Pharma), a late-stage biopharmaceutical company, today 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 (IOP) in patients previously diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT) and a concomitant cataract.

A total of 104 patients were randomized 2:1:1 to receive the 78 mcg BIM-IOL System (N=51) and 39 mcg BIM-IOL System (N=23) 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 (N=30).

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 (48 of 49) in the 78-mcg dose group and 96% of evaluable patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications.
• Evaluable patients (N=72) demonstrated vision improvement, 100% reaching 20/32 or better best corrected distance visual acuity (BCDVA) and mean BCDVA of 86 letters (equivalent to 20/20 vision).
• Adverse event (AE) rates were similar across the 78-mcg (41.2%), 39-mcg (43.5%), and control (36.7%) groups. No serious ocular AEs were observed.
  
  

“The 12-month results demonstrate the potential for the BIM-IOL System to address the key challenge of long-term adherence to ophthalmic treatments, delivering sustained IOP reduction and improved visual performance while eliminating the need for topical drops,” said Malik Kahook, M.D., chief medical officer and executive chair of the board of SpyGlass Pharma. “These positive findings from a multicenter, randomized, controlled clinical trial reinforce our previously released 3-year first-in-human data. We look forward to presenting additional Phase 1/2 trial results at a future medical conference.”

“This readout clearly demonstrates the potential for SpyGlass technology to have a life changing impact on patients, while being accessible to 100% of cataract surgeons. We’re now in a category of our own in demonstrating our ability to eliminate topical IOL-lowering medications for the vast majority of patients, while delivering the same high quality of vision that patients and surgeons expect from state-of-the-art IOLs,” said Patrick Mooney, chief executive officer of SpyGlass Pharma. “Bolstered by our confidence in the Phase 1/2 program, we remain hyper-focused on advancing enrollment for our two pivotal Phase 3 trials of the BIM-IOL System.”

In January 2026, SpyGlass Pharma announced that the first patients were randomized in two identical registrational Phase 3 trials of the 78-mcg dose of the BIM-IOL System. The Phase 3 trials are largely consistent in trial design with the SpyGlass Pharma Phase 1/2 trial with minor protocol modifications intended to improve consistency across trial arms.

About the Phase 1/2 Trial
The Phase 1/2 trial is a prospective, multicenter, randomized, double-masked, controlled clinical trial evaluating the safety and efficacy of the innovative BIM-IOL System in patients with OAG or OHT undergoing cataract surgery. A total of 104 evaluable patients were randomized 2:1:1 to receive the 78 mcg BIM-IOL System (N=51) with daily administration of artificial tear drops, 39 mcg BIM-IOL System (N=23) with daily administration of artificial tear drops, or a commercially available monofocal IOL with twice-daily administration of timolol eye drops as the control group (N=30).

The primary endpoint is mean IOP reduction from baseline at two time points for each follow-up visit at the 2 Weeks, 6 Weeks, and 3 Months. Secondary endpoints include mean IOP reduction from baseline, mean IOP, time to reintroduction and number of IOP-lowering medications, and improvement of visual performance. The trial also includes typical safety assessments for both medication and IOL.

About the Bimatoprost Drug Pad-IOL System
SpyGlass Pharma’s lead product candidate, the Bimatoprost Drug Pad-IOL System (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 intraocular pressure (IOP) in patients who have either open-angle glaucoma (OAG) or ocular hypertension (OHT). The BIM-IOL System is designed to consistently deliver multiple 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 first-in-human trial and Phase 1/2 trial as well as patient enrollment in ongoing Phase 3 clinical trials. SpyGlass 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. 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 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 final 424B4 prospectus filed with the Securities and Exchange Commission (SEC) on February 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
nsurendranath@dnacommunications.com

Investor Contact:
Ami Bavishi or Nick Colangelo
Gilmartin Group LLC
investors@spyglasspharma.com

FAQ

What were SpyGlass Pharma's 12-month BIM-IOL System IOP results (SGP)?

The BIM-IOL System showed substantial IOP reduction at 12 months, 34% (78-mcg) and 42% (39-mcg). According to the company, the control group had a 35% IOP reduction at the 8 a.m. timepoint, with similar results at 10 a.m.

How many patients in the SGP Phase 1/2 trial were free of topical IOP medications at 12 months?

Nearly all evaluable patients stopped topical meds: 98% (78-mcg) and 96% (39-mcg). According to the company, these rates reflect patients evaluable at the 12-month visit across the randomized 104-patient cohort.

What visual acuity outcomes did SpyGlass report for the BIM-IOL System (SGP)?

All evaluable patients achieved 20/32 or better BCDVA with a mean of 86 letters (≈20/20). According to the company, vision performance matched state-of-the-art monofocal IOLs used in the control arm.

Were there serious ocular adverse events reported in SpyGlass's 12-month readout (SGP)?

No serious ocular adverse events were observed across treatment and control groups. According to the company, overall AE rates were comparable: 41.2% (78-mcg), 43.5% (39-mcg) and 36.7% control.

What trial progress did SpyGlass announce after the Phase 1/2 BIM-IOL results (SGP)?

SpyGlass began randomizing patients in two identical registrational Phase 3 trials in January 2026. According to the company, the Phase 3 design largely mirrors Phase 1/2 with minor protocol consistency adjustments.

How large was the Phase 1/2 BIM-IOL System study population and randomization (SGP)?

The trial randomized 104 patients in a 2:1:1 ratio: 51 to 78-mcg, 23 to 39-mcg, and 30 to control. According to the company, treatments included artificial tears for BIM-IOL and timolol drops for control.