A Therapeutic Non-Inferiority, Randomized, Observer-blind, Active-comparator, Two-arm, Parallel Group, Multi-center Clinical Trial for Comparing the Efficacy and Tolerability of a Generic Fixed Dose Combination of Brimonidine Tartrate 2 mg/ml + Timolol 5 mg/ml Eye Drops versus Combigan® 2 mg/ml + 5 mg/ml Eye Drops in the Treatment of Intraocular Pressure in Patients with Open Angle Glaucoma or Ocular Hypertension

Start Date01 May 2026

Sponsor / Collaborator

OmniVision GmbH

ACTRN12626000236392

/ Not yet recruitingPhase 2/3IIT

Comparison of Topical Timolol with Oral Propranolol in Terms of Efficacy and Treatment Outcomes for Infantile Hemangiomas: A Randomized Controlled Trial.

Start Date18 Mar 2026

Sponsor / Collaborator

King Edward Medical University

TCTR20251201009

/ Not yet recruitingPhase 2IIT

Efficacy and safety of Castellani paint and topical timolol for treating epidermal growth factor receptor inhibitors induced paronychia: a randomized, intraindividual study

Start Date25 Aug 2025

Sponsor / Collaborator-

100 Clinical Results associated with Timolol

100 Translational Medicine associated with Timolol

100 Patents (Medical) associated with Timolol

5,377

Literatures (Medical) associated with Timolol

01 Feb 2026·Journal of Cosmetic Dermatology

A Systematic Review and Meta‐Analysis of the Efficacy and Safety of Propranolol Versus Other Drugs in the Treatment of Infantile Hemangioma

Review

Author: Hu, Jiahua ; Kong, Hong ; Pan, Lisha ; Lou, Jiaqi

ABSTRACT:

Objective:

This study aimed to systematically evaluate and compare the efficacy and safety of propranolol versus atenolol, corticosteroids, timolol, and other therapies in the treatment of infantile hemangioma (IH) through a meta‐analysis, thereby providing evidence‐based guidance for clinical practice.

Methods:

A comprehensive literature search was conducted across PubMed, Cochrane Library, EMBASE, Web of Science, CNKI, and Wanfang databases from inception to December 2025. The protocol was prospectively registered with PROSPERO (CRD420261294316). Randomized controlled trials (RCTs) or clinical controlled trials (CCTs) comparing oral propranolol with other active drugs in IH patients aged ≤ 12 years were included. Primary outcomes were overall response rate (≥ 50% reduction), complete remission rate, and incidence of adverse events. Two reviewers independently performed study selection, data extraction, and quality assessment using the Cochrane RoB 2.0 tool and Newcastle‐Ottawa Scale. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using R software. Heterogeneity was assessed using the I2 statistic.

Results:

Eight studies involving 900 patients (propranolol: 464; control: 436) were included. Meta‐analysis revealed no statistically significant difference in overall response rate between propranolol and control groups (pooled OR = 1.29, 95% CI: 0.80–2.09, p = 0.30). However, propranolol demonstrated a significantly higher complete remission rate (OR = 1.35, 95% CI: 1.01–1.82, p = 0.045). Subgroup analyses by control drug type (atenolol, corticosteroids, timolol, combination therapy) showed no significant differences in efficacy (all p > 0.05). Safety analysis indicated no significant difference in adverse event incidence between groups (OR = 0.76, 95% CI: 0.38–1.55, p = 0.45), albeit with moderate heterogeneity ( I2 = 56%). Heterogeneity was low for efficacy outcomes ( I2 = 0%). Funnel plot symmetry and a non‐significant Egger's test suggested a low risk of publication bias.

Conclusion:

Propranolol offers a statistically significant advantage in achieving complete remission of infantile hemangioma compared to other active agents, while maintaining comparable overall response rates and a similar overall safety profile. These findings support propranolol as a first‐line therapy when complete lesion resolution is the primary goal. Atenolol represents an effective alternative, particularly for patients with specific tolerability concerns, underscoring the need for individualized treatment selection.

01 Feb 2026·Journal of the Chinese Medical Association

Efficacy and safety of preservative-free versus preserved timolol eye drops in glaucoma: A randomized crossover study

Article

Author: Chen, Mei-Ju ; Ko, Yen-Huei ; Liu, Catherine Jui-Ling ; Ko, Yu-Chieh ; Chang, Yu-Fan ; Fan, Chia-Chi ; Kuang, Tung-Mei

Background::

The efficacy and safety of preservative-free timolol (PF-timolol) vs preserved timolol (P-timolol) have not been compared in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).

Methods::

In this randomized, crossover, single-center study, patients received PF-timolol twice daily or P-timolol once daily for 6 weeks, followed by crossover to the alternate treatment for 6 weeks. The primary endpoint was the change in intraocular pressure (IOP) between treatment groups. Secondary endpoints were tear film breakup time (TBUT), superficial punctate keratopathy (SPK) score, conjunctival hyperemia, systemic vital signs, and patient-reported symptoms.

Results::

Thirty-four patients (mean age 58.1 years; male 50%) were enrolled. At baseline, mean IOP was 13.6 ± 2.7 mmHg (right eye, OD) and 13.4 ± 2.7 mmHg (left eye, OS). At week 6, PF-timolol led to a greater reduction in IOP in the OD vs P-timolol (−1.3 ± 1.5 mmHg vs −0.2 ± 1.2 mmHg; p = 0.004), whereas no significant difference was observed in the OS ( p = 0.08). At week 12, the mean IOP did not differ between the two groups for both eyes. TBUT increased in the PF-timolol group but decreased in the P-timolol group ( p = 0.006), and the change from baseline favored PF-timolol ( p = 0.001). The SPK score decreased significantly more in the OD in the PF-timolol group than P-timolol group (−0.4 ± 0.8 4 vs 0.2 ± 1.1; p = 0.03). S ystemic vital signs remained stable throughout the study. Patient-reported symptoms were comparable between groups.

Conclusion::

PF-timolol eye drops achieved a greater IOP reduction at week 6 but showed comparable efficacy to P-timolol by week 12, while providing additional advantages in ocular safety outcomes and subjective tolerability. PF-timolol offers an effective and safer option for glaucoma management, particularly in patients sensitive to preservatives.

01 Feb 2026·Recent Advances in Inflammation & Allergy Drug Discovery

Prevention of Chemotherapy-related Oral Mucositis by Topical Timolol: A Prospective Randomized, Double-blind, Placebo-controlled Clinical Trial in Cancer Patients

Article

Author: Saghafi, Fatemeh ; Shaker-Ardakani, Fatemeh ; Nabi-Meybodi, Mohsen ; Sahebnasagh, Adeleh ; Vahedian-Ardakani, Hassan-Ali

Background::

Timolol is a beta-adrenergic blocker that has been shown to be effective in the healing of wounds. Oral mucositis (OM), an acute inflammation of the oral mucosa, is a bothersome side effect of some regimens of chemotherapy in which the oral mucosa becomes ulcerated. The current study aimed to evaluate the prophylactic effects of timolol mouthwash in preventing OM in adult patients receiving chemotherapy compared to the placebo

Methods::

This randomized, double-blind trial was conducted on 30 adult patients receiving chemotherapy regimen, including doxorubicin or 5-fluorouracil (5-FU). The patients were randomized in a 1:1 ratio to receive either timolol 0.5% (w/v) (n = 15) or placebo (n = 15) mouthwash 5 ml three times per day. The outcomes of the study were the intensity of OM evaluated by the World Health Organization (WHO) mucositis scale and OM-related pain based on the Visual Analog Scale (VAS) weekly during the seven weeks of the study period.

Results::

The results of the study showed that the scores of WHO mucositis scale significantly decreased in the timolol group compared to the control group during the study [week 1: mean (SD), 0.02 (0.41) in the timolol group, and 0.67 (0.48) in the control group; week 7: mean (SD), 0.33 (0.61) in the timolol group, and 0.87 (0.74) in the control group; P-value = 0.049]. Moreover, the mean pain scores significantly decreased in the first, second, and third weeks in the timolol group compared to the control group (P-value < 0.05).

Conclusion::

The results of this preliminary clinical trial demonstrated that among the patients receiving doxorubicin or 5-FU chemotherapy regimens, the preventive use of timolol mouthwash significantly diminished the severity of OM compared to the control group during the seven weeks of follow-up. The severity of pain was also significantly lower during the first three weeks of the study; however, the effect size was less than the minimal clinically important difference. Further studies are required to assess both the long-term efficacy and safety of timolol mouthwash in preventing OM.

News (Medical) associated with Timolol

27 Mar 2026

·www.biospace.com

SpyGlass Pharma Reports Fourth Quarter and Full Year 2025 Earnings and Provides a Corporate Update

Successfully completed Initial Public Offering (IPO) in February 2026, raising $172.5 million and listing on Nasdaq. Reported positive topline 12-month data from Phase 1/2 trial of the Bimatoprost Drug Pad-IOL System (BIM-IOL System) that demonstrated sustained intraocular pressure (IOP) control, elimination of IOP-lowering eye drops for 97% of trial participants, and improved visual performance, with a favorable safety profile. Phase 3 trials of BIM-IOL System are ongoing, with enrollment underway and full enrollment expected in 2027. Cash, cash equivalents and short-term investments expected to fund planned operations through 2028. ALISO VIEJO, Calif., March 26, 2026 (GLOBE NEWSWIRE) -- SpyGlass Pharma, Inc. (Nasdaq: SGP) (“SpyGlass Pharma” or “Company”), a late-stage biopharmaceutical company, today reported recent business highlights and financial results for the fourth quarter and year ended December 31, 2025. “2025 was an important year for SpyGlass, as we advanced the development of our BIM-IOL System, including the initiation of two Phase 3 trials. We look forward to bringing our innovative technology to more patients and more surgeons,” stated Patrick Mooney, chief executive officer of SpyGlass Pharma. “2026 is off to an exceptional start, highlighted by our successful IPO that funds the Phase 3 trials of the BIM-IOL System as well as the planned initiation of a first-in-human trial of the Bimatoprost Drug Ring System (BIM-DRS), which potentially expands our market opportunity. We remain deeply focused on delivering long-term, eye drop-free therapy for the approximately one million glaucoma and ocular hypertension patients who undergo cataract surgery in the United States each year.” BIM-IOL System Program Highlights 12-Month Phase 1/2 Data of BIM-IOL System. In March 2026, SpyGlass Pharma announced positive topline results from its Phase 1/2 trial of the BIM-IOL System, which evaluated two dose levels of 78-mcg (N=51), the intended commercial dose, and 39-mcg (N=23) compared to a physician's choice of commercially available monofocal IOLs from Alcon, Bausch + Lomb or Johnson & Johnson with twice-daily administration of timolol eyedrops as the control group (N=30). Evaluable patients receiving the BIM-IOL System achieved a time-matched reduction of 34% and 42% in mean IOP from baseline in the high and low 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. Additionally, 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 12 months after surgery. The BIM-IOL System demonstrated improved visual performance, in line with the control group with 100% (72 of 72) of trial participants receiving the BIM-IOL System reaching 20/32 or better best corrected distance visual acuity (BCDVA), and mean BCDVA of 86 letters, which is equivalent to 20/20 vision. The BIM-IOL System was well tolerated and exhibited a safety pro to routine cataract surgery, with no serious ocular adverse events (AEs) observed. SpyGlass Pharma anticipates presenting additional Phase 1/2 trial results at a future medical meeting. First Patients Randomized and First Surgeries Completed in Phase 3 Trials. In January 2026, SpyGlass Pharma announced that it randomized the first patients in SGP-005 and SGP-006, the Company’s two registrational Phase 3 clinical trials to demonstrate non-inferiority of the BIM-IOL System in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) undergoing cataract surgery compared to a standard of care, commercially available IOL with twice-daily administration of timolol eye drops. The co-primary endpoints are the time-matched change in mean IOP from baseline, as well as the proportion of patients achieving BCDVA of 20/40 or better. 36-Month First-in-Human (FIH) Data of BIM-IOL System. In November 2025, at the Interventional Glaucoma Consortium Meeting, SpyGlass Pharma announced 36-month follow-up data from its FIH study of the BIM-IOL System, demonstrating a 37% reduction in mean IOP across all dose groups and reporting that 95% of patients were off all topical IOP-lowering drops. Additionally, 100% of evaluable patients achieved 20/30 or better BCDVA. No product-related AEs were reported. Presentation at Premier Interventional Glaucoma Medical Meeting. In February 2026, Dr. Nathan Radcliffe, a seasoned glaucoma and cataract surgeon at the New York Eye Surgery Center and member of SpyGlass Pharma’s medical advisory board, presented data generated to date in the FIH and Phase 1/2 trials of the BIM-IOL System and an overview of SGP-005 and SGP-006’s trial designs at the Glaucoma Innovation Summit (GIS) at the American Glaucoma Society’s 2026 Annual Meeting. Corporate Highlights Completion of Initial Public Offering. On February 9, 2026, SpyGlass Pharma closed its initial public offering, raising approximately $172.5 million in gross proceeds, including the full exercise of the underwriters’ option to purchase additional shares. Strengthened Leadership. In February 2026, upon completion of its IPO, SpyGlass Pharma enhanced its board of directors with the appointment of independent director Habib Dable, who has over 30 years of industry experience, of which ten were in the ophthalmology pharmaceutical buy-and-bill space, and currently serves as an advisor at RA Capital Management. Additionally, in January 2026, SpyGlass Pharma appointed Jean-Frédéric Viret, Ph.D., as chief financial officer. Dr. Viret has over two decades of experience in life sciences and corporate finance with commercial late-stage clinical development companies. Fourth Quarter and Full Year 2025 Financial Results Cash, Cash Equivalents and Short-Term Investments totaled $107.4 million as of December 31, 2025. This balance excludes proceeds from the Company’s initial public offering of $172.5 million before associated underwriting discounts, commissions and other offering costs. With the IPO proceeds, SpyGlass Pharma expects its current cash position to fund planned operations through 2028. Research and Development Expenses were $7.7 million for the fourth quarter of 2025 and $29.2 million for the year ended December 31, 2025, compared to $5.7 million and $20.0 million, respectively, for the same periods of 2024. The increase was primarily due to the hiring of clinical and research personnel and the initiation of the registrational Phase 3 trials of the BIM-IOL System. General and Administrative Expenses were $5.9 million for the fourth quarter of 2025 and $12.3 million for the year ended December 31, 2025, compared to $2.0 million and $7.1 million, respectively, for the same periods of 2024. The increase was primarily due to higher professional services and personnel. Net Loss was $12.6 million, or ($5.72) per basic and diluted share, for the fourth quarter of 2025, compared to $8.4 million, or ($4.58) per basic and diluted share, for the fourth quarter of 2024. Net loss for the year ended December 31, 2025 was $39.9 million, or ($17.98) per basic and diluted share, compared to $29.2 million, or ($16.31) per basic and diluted share, for the year ended December 31, 2024. Upcoming Milestones BIM-DRS: Initiation of the FIH trial in the second half of 2026. BIM-IOL: Four-year efficacy and safety follow-up on the FIH trial in fourth quarter of 2026. 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 clinical data, the initiation of the FIH trial for BIM-DRS, SpyGlass Pharma’s cash runway, the reporting of the four-year data from the BIM-IOL FIH trial, and SpyGlass Pharma’s plans relating to the clinical development of the BIM-IOL System toward commercial approval, including enrollment completion timing. 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 annual report on Form 10-K for the fiscal year ended December 31, 2025 filed with the Securities and Exchange Commission on or about the date hereof, and in similar disclosures set forth in the other documents that SpyGlass Pharma has filed and may time to time with the SEC, including the final IPO prospectus filed on February 6, 2026. 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. SpyGlass Pharma’s views in these forward-looking statements should not be relied as representing the Company’s views as of any date subsequent to the date of this press release. Media Contact: Nami Surendranath +1 (402) 507-6757 nsurendranath@dnacommunications.com Investor Contact: Ami Bavishi or Nick Colangelo Gilmartin Group LLC investors@spyglasspharma.com SpyGlass Pharma, Inc. Condensed Statements of Operations (in thousands, except share and per share data) For the Three Months Ended December 31, For the Year Ended December 31, 2025 2024 2025 2024 Operating expenses Research and development $ 7,705 $ 5,740 $ 29,183 $ 19,984 General and administrative 5,923 2,014 12,266 7,080 Total operating expenses 13,628 7,754 41,449 27,064 Loss from operations (13,628 ) (7,754 ) (41,449 ) (27,064 ) Other income (expense) Interest income 1,073 207 3,106 1,317 Change in fair value of redeemable convertible preferred stock tranche liability - (852 ) (1,526 ) (3,417 ) Total other income (expense) 1,073 (645 ) 1,580 (2,100 ) Loss before income tax (12,555 ) (8,399 ) (39,869 ) (29,164 ) Income tax provision - - - - Net loss and comprehensive loss $ (12,555 ) $ (8,399 ) $ (39,869 ) $ (29,164 ) Net loss per share Weighted average common stock outstanding, basic and diluted 2,195,210 1,834,216 2,217,104 1,788,211 Net loss per share of common stock, basic and diluted $ (5.72 ) $ (4.58 ) $ (17.98 ) $ (16.31 ) SpyGlass Pharma, Inc. Condensed Balance Sheets (in thousands, except share and per share data) As of December 31, 2025 2024 Assets Current assets Cash and cash equivalents $ 96,358 $ 16,268 Short-term investments 11,078 - Other receivables 431 423 Prepaid expenses and other current assets 901 715 Total current assets 108,768 17,406 Other non-current assets 492 453 Property and equipment, net 2,339 2,168 Deferred offering costs 2,715 - Right-of-use asset 1,552 3,291 Total assets $ 115,866 $ 23,318 Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Deficit Current liabilities Accounts payable $ 2,696 $ 1,978 Payroll-related accruals 2,182 1,282 Other current liabilities 3,706 672 Lease liability, current - 442 Redeemable convertible preferred stock tranche liability - 3,417 Total current liabilities 8,584 7,791 Lease liability, non-current 1,582 3,455 Total liabilities 10,166 11,246 Commitments and contingencies Redeemable convertible preferred stock, $.00001 par value; 116,618,581 shares authorized, 20,341,968 and 9,608,914 shares issued and outstanding as of December 31, 2025 and 2024, respectively (aggregate liquidation preference of $200,878 and $73,542 as of December 31, 2025 and 2024, respectively) 204,537 72,546 Stockholders' deficit Common stock, $.00001 par value; 154,383,336 shares authorized; 2,203,620 and 2,196,423 shares issued and outstanding as of December 31, 2025 and 2024, respectively - - Common stock additional paid-in capital 5,893 4,387 Accumulated deficit (104,730 ) (64,861 ) Total stockholders' deficit (98,837 ) (60,474 ) Total liabilities, redeemable convertible preferred stock and stockholders' deficit $ 115,866 $ 23,318

Phase 3Clinical ResultFinancial StatementExecutive ChangeIPO

09 Mar 2026

·www.biospace.com

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

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 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

Clinical ResultPhase 3NDADrug Approval

20 Jan 2026

·www.biospace.com

SpyGlass Pharma Announces First Patients Randomized in SGP-005 and SGP-006, Two Registrational Phase III Clinical Trials of Its Novel BIM-IOL System

ALISO VIEJO, Calif., Jan. 20, 2026 (GLOBE NEWSWIRE) -- SpyGlass Pharma, a late-stage biopharmaceutical company, today announced that the first patients have been randomized in two registrational Phase III clinical trials of its lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), for lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). “The inconsistent use of topical IOP-lowering drops is a significant challenge in managing the estimated 1 million glaucoma and OHT patients who are expected to undergo cataract surgery in the United States this year,” said Chetan Pujara, Ph.D., Chief Research & Development Officer of SpyGlass Pharma. “Randomizing the first patients in our registrational Phase III clinical trials represents a critical step toward bringing our BIM-IOL System to market – a much-needed solution to help patients overcome this burden.” "As an investigator in the Phase I/II clinical trial, I’ve witnessed firsthand how the BIM-IOL System can eliminate the need for drops by providing sustained IOP control in patients with OAG or OHT," said Fiaz Zaman, M.D., F.A.C.S., ophthalmologist at Houston Eye Associates. "I look forward to participating in the Phase III clinical trials and collaborating with both SpyGlass Pharma and my fellow investigators to potentially bring the BIM-IOL System to patients. The next frontier of managing and preventing glaucoma disease progression will be therapeutic technologies that remove the patient adherence challenge.” “Today’s exciting milestone brings us one step closer to offering the roughly 10,000 cataract surgeons – including the two-thirds who do not routinely perform minimally invasive glaucoma surgery – the promise of seamlessly integrating sustained bimatoprost drug delivery into cataract surgery,” said Patrick Mooney, Chief Executive Officer of SpyGlass Pharma. “Backed by robust clinical data and an optimized Phase III trial design that builds on learnings from our earlier studies, we believe SpyGlass Pharma’s BIM-IOL System is well-positioned to advance through clinical development for potential commercial approval.” ABOUT THE PHASE III PROGRAM The Phase III clinical trial program consists of two prospective, multicenter, randomized, masked, controlled clinical trials, SGP-005 and SGP-006, evaluating the efficacy and safety of the BIM-IOL System in patients with OAG or OHT undergoing cataract surgery. Each trial is expected to enroll approximately 400 participants and is designed to demonstrate non-inferiority of the BIM-IOL System to a standard of care commercial intraocular lens (IOL) with twice-daily administration of timolol eye drops. The co-primary endpoints are the time-matched change in mean IOP from baseline, as well as the proportion of patients achieving best corrected distance visual acuity (BCDVA) of 20/40 or better. The studies will also measure change in mean IOP, time to postoperative introduction of IOP-lowering medications, and number of IOP-lowering medications introduced postoperatively. Participants will be monitored for up to 36 months to evaluate long-term safety, efficacy, and durability. 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 three 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 initiated two registrational Phase III clinical trials of the BIM-IOL System and continues long-term follow-up of patients in the Phase I/II study investigating the safety and efficacy of the BIM-IOL System. SpyGlass Pharma plans to work with the FDA to advance the program through completion of Phase III clinical trials, New Drug Application 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 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 Platform was originally developed in the Sue Anschutz-Rodgers Eye Center of the University of Colorado School of Medicine. For more information, visit . FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements including, but not limited to, statements regarding the expected number of glaucoma and OHT patients to undergo surgery in the United States this year, expected trends in management and treatment of glaucoma, our plans relating to the clinical development of the BIM-IOL System towards commercial approval, including expected enrollment, and the potential advantages of the SpyGlass platform and the BIM-IOL System. These statements are based on numerous assumptions and involve substantial risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievement to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements in this press release are as of the date of this press release. 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 +1 (212) 418-8981 nsurendranath@dnacommunications.com Investor Contact: Ami Bavishi or Nick Colangelo Gilmartin Group LLC investors@spyglasspharma.com

Phase 3

100 Deals associated with Timolol

External Link

KEGG	Wiki	ATC	Drug Bank
D08600	Timolol	S01ED01 C07AA06	DB00373

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	United States	Thea Pharma Inc.	31 Mar 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glaucoma, Open-Angle	Phase 3	Belgium	Alcon Research Ltd.	18 Jan 2006
Glaucoma	Phase 3	United States	Alcon Research Ltd.	01 Jan 2003
Dry Eye Syndromes	Phase 2	-	Novaliq GmbH	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03193333 (Pubmed \| Clin Ophthalmol)	Phase 3	Glaucoma	43	Timolol, Dorzolamide, and Brimonidine Preservative-Free Fixed Combination	ssbbdilyby(sytuhpeqtq) = rwgyvnsvvd hfhhhcqeup (pvbrhgbeoz ) View more	Positive	01 Feb 2026
				Timolol, Dorzolamide, and Brimonidine with Preservatives Fixed Combination	ssbbdilyby(sytuhpeqtq) = hquoxnbwmt hfhhhcqeup (pvbrhgbeoz ) View more
NCT01677507 (ARVO2025)	Phase 1	Ocular Hypertension	106	Latanoprost	jxizloyfpo(tdwdqnupun) = wjfozkflgj hqhvaaygbi (jfznydjnqr )	Positive	04 May 2025
				Timolol	jxizloyfpo(tdwdqnupun) = pypdxflrky hqhvaaygbi (jfznydjnqr )
NCT03282981 (BAART-DFU, CTgov)	Phase 3	Diabetic foot ulcer \| Wounds and Injuries	48	Timolol (Timolol)	hkysqrsprd = dhkiyfkzhs wsthgmdmdi (louqmecowi, todwglxeba - vhdctbjjxo) View more	-	25 Apr 2025
				Non biologically active gel (SOC Plus Non Biologically Active Gel)	hkysqrsprd = ykxnhmhczi wsthgmdmdi (louqmecowi, eteozbxuwe - ptquqjunsb) View more
NCT04910100 (CTgov)	Phase 2	Glaucoma, Open-Angle	226	Nebivolol Ophthalmic Suspension 1 Percent (Nebivolol Ophthalmic Suspension 1 Percent)	zpjwhxktwj(vewfsyxxne) = ctqjbkfteb vsqiuqeqsi (zppfznexpy, fxgwqonsmp - ezullfhvsy) View more	-	17 Apr 2024
				Nebivolol Ophthalmic Suspension 0.5 Percent (Nebivolol Ophthalmic Suspension 0.5 Percent)	zpjwhxktwj(vewfsyxxne) = tqqmcndosa vsqiuqeqsi (zppfznexpy, outfhnclai - rydlrtgpny) View more
NCT03836664 (CTgov)	Phase 2	Migraine Disorders	25	Timolol (All Participants Post Timolol)	fhddjzlacq(dhamibtdxx) = mwfchbzjwx diyjuhclmw (mvozzbulqz, nbdmlmhdjq - wnggcpzueb) View more	-	02 Jul 2019
				placebo+Timolol (All Participants Post Placebo)	fhddjzlacq(dhamibtdxx) = naedwhfssu diyjuhclmw (mvozzbulqz, xhwkliwejz - yzjklohldo) View more
NCT01677507 (ARVO2019)	Phase 4	-	121	Timolol 0.5%	winmasrqja(udxsabomna) = oaxfntvuty gtlchicqer (utcoelcoof, 7.9)	Positive	01 Jul 2019
				Latanoprost 0.005%	winmasrqja(udxsabomna) = xqlvstfunc gtlchicqer (utcoelcoof, 7.9)
NCT02630719 (CTgov)	Not Applicable	Migraine Disorders	10	Timolol eye drops (Timolol Eye Drops)	tlkcjguchv(rjxmjrqiyd) = vogtatceny hfowtlmchd (nxknitghzs, 31) View more	-	15 May 2019
				Artificial tears (Artificial Tears)	tlkcjguchv(rjxmjrqiyd) = vagffgvobf hfowtlmchd (nxknitghzs, 30) View more
NCT00572936 (CTgov)	Phase 2	Glaucoma	30	Latanoprost (Latanoprost)	pqwyhighxu(mzdlylovrk) = pexrahsmou ernfhdlqbz (eevsvczyvl, 3.7) View more	-	14 Feb 2018
				Timolol (Timolol)	pqwyhighxu(mzdlylovrk) = bprdithnor ernfhdlqbz (eevsvczyvl, 2.3) View more
NCT01677507 (CTgov)	Phase 4	Glaucoma	135	timolol+latanoprost (Timolol)	rbeeesgfnz(nfvrxdyqar) = vcuqkttumw gkpvjaievi (hsvotgvuru, 3.2) View more	-	13 Sep 2017
				timolol+latanoprost (Latanoprost)	rbeeesgfnz(nfvrxdyqar) = lpufcrytea gkpvjaievi (hsvotgvuru, 3.2) View more
NCT02097719 (CTgov)	Phase 4	Glaucoma	100	hypromellose 0.3%+bimatoprost 0.01% (Bimatoprost 0.01% and Hypromellose 0.3%)	cavjtjsdhx(offusqpkdx) = jviyzszlrm sstohhdhhw (johevsmdbr, 0.50) View more	-	14 Jan 2016
				timolol 0.5%+travoprost 0.004% (Travoprost 0.004% and Timolol 0.5%)	cavjtjsdhx(offusqpkdx) = susosbnrqn sstohhdhhw (johevsmdbr, 0.48) View more

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