The objective of this study is to evaluate whether reduction in topical medication with the injection of a sustained release capsule (Durysta) leads to a reduction in ocular surface inflammation, indicated by levels of caspase-1, an inflammatory biomarker.

Start Date31 Jan 2026

Sponsor / Collaborator

University of Miami

[+1]

NCT07218796

/ RecruitingPhase 3

A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,

This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.

Start Date28 Oct 2025

Sponsor / Collaborator

SpyGlass Pharma Inc

NCT07218783

/ RecruitingPhase 3

Start Date15 Oct 2025

Sponsor / Collaborator

SpyGlass Pharma Inc

100 Clinical Results associated with Bimatoprost

100 Translational Medicine associated with Bimatoprost

100 Patents (Medical) associated with Bimatoprost

1,060

Literatures (Medical) associated with Bimatoprost

01 Nov 2025·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

DoE based development and optimization of ion sensitive in situ nanoemulgel containing bimatoprost for sustained ocular delivery

Article

Author: Singh, Rahul Pratap ; Singh, Monika ; Jhawat, Vikas ; Monika ; Devi, Meena

BACKGROUND:

The primary treatment for glaucoma involves the chronic instillation (daily) of intraocular pressure (IOP)-lowering eye drops to manage disease progression and prevent vision loss. Bimatoprost is a prostaglandin analogue used in glaucoma and ocular hypertension.

OBJECTIVE:

The objective of the present study was to formulate and evaluate a novel in situ nanoemulgel (NEG) of bimatoprost for ocular drug delivery (ODD).

METHODS:

Bimatoprost (Drug), Hyaluronic acid (HA), Algal oil (oil phase), liquid soya lecithin (Emulsifier 1), and tween 40 (emulsifier II), and water (Aqueous phase) were components for the formulation, and the nanoemulsion was prepared by high-pressure homogenization. The optimization of formulation was done with Quality by Design (QbD), and the optimized formulation was further evaluated for Zeta size, Zeta potential, PDI, and Surface morphology. The final nanoemulsion formulation was transformed into a gel system using Gellan Gum (GG) as the gelling agent. After incorporation in the gelling system, the developed nanoemulgel (NEG) was further evaluated for clarity, pH, sol-gel transition, rheology, drug content, sterility, isotonicity, and in vitro drug release. Pharmacodynamic studies have been performed for the evaluation of IOP, Dry eye test, and conjunctival hyperemia measurement.

RESULTS:

Optimized nano emulsion had 7.5 % oil, 22.5 % Liquid soya Lecithin & Tween 40 [S_mix(1:1)] and 70 % water with particle size, Zeta potential and Poly dispersed index (PDI) range as 38.87 ± 0.91, 34.3 ± 0.34 and 0.282 ± 0.04 respectively. The developed formulation (NEG) showed evidence of sol-gel transition or in situ gelation after combining with artificial tear fluid. The drug content in developed NEG was found to be 99.76 ± 0.65 %. In-vitro drug release results of optimized bimatoprost-loaded NEG offered sustained delivery of the drug with an anisotropic diffusion. The developed formulation was found to be stable, isotonic, and sterile. Pharmacodynamic evaluation revealed a significant decrease in IOP with the developed formulation (NEG). Other than this, adverse drug reactions (ADR) associated with anti-glaucoma medication, i.e., dry eye and conjunctival hyperemia, were addressed by developing NEG with omega-3 fatty acid and HA.

CONCLUSION:

This novel formulation offers a competitive option to traditional eye drops because of its prolonged precorneal residence duration and sustained medication release. Pharmacodynamic evaluations demonstrated that the developed NEG formulation enriched with omega-3 fatty acids and hyaluronic acid (HA) provided superior glaucoma management while simultaneously mitigating the adverse effects commonly associated with conventional anti-glaucoma therapies.

24 Sep 2025·Retinal cases & brief reports

Peripapillary retinoschisis associated with open angle glaucoma responding to dorzolamide

Article

Author: Golebka, Jedrzej ; Flynn, Erin ; Chang, Stanley ; Moussa, Omar

Purpose::

Presenting a case of peripapillary retinoschisis in a patient with glaucomatous optic neuropathy that resolved after changing therapy from topical bimatoprost to timolol/dorzolamide.

Methods::

A 70-year-old female who presented for a second opinion for peripapillary retinoschisis in the left eye.

Results::

The patient’s visual acuity was 20/25 and 20/30 in the right and left eyes, respectively. Dilated fundoscopy revealed posterior vitreous detachment (PVD) of the left eye, temporal cupping with a superotemporal notch of the left optic nerve, and bilateral macular drusen and pigmentary changes of the retinal pigment epithelium (RPE). Optical coherence tomography of the macula of the left eye showed a PVD, drusen, and peripapillary retinoschisis extending to and involving the fovea. Topical prostaglandin analogue eye drop was discontinued and replaced by dorzolamide/timolol. The peripapillary retinoschisis resolved after medication change over the following 48 months and has not recurred.

Conclusion::

We present a case of peripapillary retinoschisis in a phakic patient that developed during treatment with a topical prostaglandin analogue. The schisis resolved after switching the prostaglandin analogue to a topical carbonic anhydrase inhibitor. We suggest that the prostaglandin may have had a role in initiating peripapillary retinoschisis associated with glaucomatous optic neuropathy and that carbonic anhydrase inhibitors are a potential treatment for this condition.

01 Sep 2025·EUROPEAN JOURNAL OF OPHTHALMOLOGY

Intraoperative optical coherence tomography in glaucoma surgery with Ex-PRESS ^® implant

Article

Author: Platas Moreno, Irene ; Guerrero Altares, Laura ; Morote, Ignacio Jiménez-Alfaro ; Martin-Gutierrez, M Pilar

Introduction:

To present the correct placement of the Ex-PRESS ® implant in the anterior chamber with the intraoperative optical coherence tomography (i-OCT) scan. To the best of our knowledge, this is the first publication to report the use of i-OCT during an Ex-PRESS ® glaucoma implant procedure.

Case report:

We report the case of a phakic, 48 year-old South American male with bilateral advanced pigmentary glaucoma. Our patient was being treated with dorzolamide-timolol eyedrops twice daily and bimatoprost eyedrops once daily in both eyes. Glaucomatous damage in his left eye had progressed and it was then decided to perform filtering surgery in our patient´s left eye, using a P-50 Ex-PRESS ® shunt and two Ologen ® collagen matrix implants. As our patient was phakic, special care was taken to avoid contact with the lens. The correct placement of both subscleral devices was confirmed with the OPMI LUMERA ® 700 microscope, an i-OCT device. i-OCT scans as well as a video recording were performed throughout the surgical procedure.

Conclusion:

I-Oct can help surgeons to locate the correct placement of implants in cases such as corneal opacification or gerontoxon. This instrument is helpful in the training of ophthalmologists. I-OCT can help surgeons to locate the correct placement of implants in cases with media opacity (such as corneal opacification or gerontoxon) or in phakic patients, where it is important to avoid lens contact. This instrument is helpful in the training of ophthalmologists.

121

News (Medical) associated with Bimatoprost

10 Nov 2025

·www.globenewswire.com

SpyGlass Pharma Announces Positive 36-Month First-in-Human and 3-Month Phase I/II Trial Results for Its Novel BIM-IOL System

First-in-Human (FIH) Trial at 36 Months: 37% reduction in mean intraocular pressure (IOP) in evaluable patients across all dose groups with 95% of patients off all topical IOP-lowering drops100% of evaluable patients achieved 20/30 or better Best Corrected Distance Visual Acuity (BCDVA)No product-related adverse events (AEs) were reported Phase I/II Trial at 3 Months: 37% and 36% reduction in mean IOP with 98% and 96% of patients off topical IOP-lowering drops in 78 mcg and 39 mcg dose groups, respectively100% of patients achieved 20/40 or better BCDVA and a mean 20/20 BCDVA, in both the BIM-IOL and control groupsOverall safety results were comparable to routine cataract surgery ALISO VIEJO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- SpyGlass Pharma™, a late-stage biopharmaceutical company, announces positive results from two clinical trials of its lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), for the treatment of elevated IOP in patients with mild-to-moderate open-angle glaucoma (OAG) or ocular hypertension (OHT). The data were presented by Malik Kahook, M.D., co-founder and president of SpyGlass Pharma, at the Interventional Glaucoma Consortium (IGC) in Salt Lake City, Utah on Saturday, November 8th, which included 36-month follow-up data from the FIH trial and three-month interim safety and efficacy results from the Phase I/II trial. “The FIH results demonstrate that the BIM-IOL System can deliver sustained IOP reduction, drop-free outcomes, and strong visual performance for three years,” said Dr. Kahook. “Our Phase I/II trial aims to confirm these findings across a larger patient population and has shown similar IOP reduction and drop-free outcomes three months after implantation. Together, these results represent an important milestone for both SpyGlass and patients in need of disease control while removing the adherence burden.” "The physician community needs better sustained drug delivery options to eliminate the adherence burden of IOP-lowering drops for patients with open-angle glaucoma or ocular hypertension," said Jeffrey Kammer, M.D., associate professor of ophthalmology at Vanderbilt University Medical Center and an investigator in the Phase I/II trial. "The implantation procedure during routine cataract surgery is straightforward, and the three-month IOP reduction results and improved visual performance are highly compelling. I am excited to continue to work with SpyGlass to monitor longer-term results of the BIM-IOL System.” FIH Results at 36 Months: 37% reduction in mean IOP in evaluable patients across all dose groups from 25.1 ±2.5 mmHg at baseline post-washout to 15.9 ± 2.7 mmHg. 95% of evaluable patients were off all topical IOP-lowering medications.100% of evaluable patients achieved 20/30 or better BCDVA.No product-related AEs were reported. Phase I/II Efficacy Results: Sustained IOP Control, Elimination of Drops, and Improved Visual Performance The primary endpoint of the Phase I/II trial is mean IOP reduction from baseline at the 2 Week, 6 Week, and 3 Month timepoints following implantation of the SpyGlass BIM-IOL System delivering bimatoprost at two dose levels (78 mcg and 39 mcg). The BIM-IOL System achieved a mean reduction in IOP that was comparable to the control group, which received a commercially available monofocal intraocular lens (IOL) with twice-daily timolol eye drops. At three months: Patients achieved a 37% and 36% reduction in mean IOP from baseline in the 78-mcg and 39-mcg dose groups, respectively, compared to a 37% reduction in the control group at 8 a.m. Results were similar at the 10 a.m. timepoint (Figure 1).98% of patients (49 of 50) in the 78-mcg dose group and 96% of patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications.Patients demonstrated vision improvement, reaching 20/40 or better BCDVA and mean BCDVA of 85 to 86 letters (~20/20 vision). Figure 1: Mean IOP Reduction Sustained Over Three Months Across Doses Phase I/II Safety Results: Comparable to Routine Cataract Surgery At three months: Adverse event (AE) rates were similar across the 78-mcg (35.3%), 39-mcg (39.1%), and control (33.3%) groups.No serious ocular AEs were observed. ABOUT THE FIRST-IN-HUMAN TRIAL The first-in-human (FIH) trial is a single-center, prospective trial evaluating the BIM-IOL System for the treatment of elevated IOP in patients with OAG or OHT undergoing routine cataract surgery. A total of 23 patients were sequentially assigned 1:1:1 across three BIM-IOL System dosage groups. At the 36-month timepoint, 21 evaluable patients remained, with two discontinuing due to one relocating outside the country and the other entering palliative care following a cancer diagnosis unrelated to the BIM-IOL System. ABOUT THE PHASE I/II TRIAL The Phase I/II 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 eligible 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 the 2 Week, 6 Week, and 3 Month timepoints. Secondary endpoints include mean IOP reduction from baseline, visual performance, and 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 FIH trial and Phase I/II trial. SpyGlass plans to work with the FDA to advance the program through initiation of Phase III clinical trials, 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 redefine the management of these 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 www.spyglasspharma.com. Media Contact:Nami Surendranath +1 (212) 418-8981 NSurendranath@dnacommunications.com Investor Contact: Ami Bavishi or Nick Colangelo Gilmartin Group LLC investors@spyglasspharma.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7fb74ec7-d7e9-49b4-a8b8-a97cbd1d4e3b

Clinical ResultDrug ApprovalNDA

23 Oct 2025

·www.globenewswire.com

Nicox Provides First Half 2025 Financial Results

Press Release Nicox Provides First Half 2025 Financial Results New Drug Application (NDA) submissions for NCX 470 expected in 2026 in the U.S. and ChinaCompany believes that it can finance its existing operations for at least 12 months and expects to fully repay existing financial debts in 2026 October 23, 2025 – release at 7:30 am CETSophia Antipolis, FranceNicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today provided the financial results for Nicox SA (the “Company”) for the first half of 2025, as approved by the Board of Directors on October 22, 2025, and provided an update on key future milestones. “Our recent licensing payments, financing and careful cost control have positioned us with over 12 months of operational runway and the ability to repay all existing financial debts. In addition, NCX 470 marketing authorisation preparation and filing costs are taken on by our partners, who will also be responsible for the commercialisation of NCX 470 worldwide in the over $7 billion glaucoma market. This is a significant achievement for the Company, allowing us to move forward on a solid footing. Our double focus is now on both accompanying our partners in obtaining regulatory approval for NCX 470 and exploring future growth opportunities for the company.” said Gavin Spencer, Chief Executive Officer of Nicox. Key Future Milestones NCX 470 NDA submission in the United States: expected in H1 2026.NCX 470 NDA submission in China: expected shortly after submission in the U.S. NCX 470 Phase 3 clinical program in Japan: initiated in summer 2025. Managed and financed by Kowa. Subsequent eventsThe Company received license payments in August and September totalling €12.5 million relating to the signature of the NCX 470 license to Kowa and the Denali clinical trial results, in addition to €2 million related to the initiation of clinical trails on NCX 470 in Japan. Part of these payments has been used to reduce the Company’s financial debt, which amounted to €7.4 million as of 30 September 2025 and which is expected to be fully repaid in 2026.First Half 2025 Financial Results for Nicox SA Revenue for the first half of 2025 was €1.5 million (consisting principally of license payments) versus €6.1 million (including €3.1 million of net royalty payments and a license payment of €3.0 million) for the first half of 2024. The decrease mainly reflects the sale of the VYZULTA royalty stream to Soleus in the second half of 2024.Operating expenses for the first half of 2025 were €6.8 million compared to €10.1 million for the first half of 2024. The decrease primarily reflects lower payroll expenses following the cost reductions initiated in 2024, and the end of Pfizer royalty payments after the sale of the VYZULTA royalties to Soleus.Net loss for the six months ended June 30, 2025 was €8.9 million, compared to a net loss of €4.3 million for the same period in 2024. The net loss for the first half of 2025 includes a €3.0 million foreign exchange loss on US dollar-denominated receivables and cash, versus an insignificant amount in 2024.As of June 30, 2025, Nicox SA had cash and cash equivalents of €5.7 million (excluding receipt of €12.5 million of license payments and partial debt repayment after the reporting period, as set out above) as compared with €10.5 million as of December 31, 2024. Based on the expected upcoming milestones and the repayment of all existing financial debts, the Company is financed for at least 12 months. The Company remains committed to cost control and optimizing resource allocation while maintaining the capabilities required to support our strategic objectives. If any of the assumptions around estimated income or costs change, this may impact the cash runway of the Company.As of June 30, 2025, Nicox SA had financial debt of €14.8 million as compared with €15.1 million as of December 31, 2024. Only the figure related to the cash position and the debt of Nicox SA as of December 31, 2024, is audited; all other figures in this press release are non-audited. About NicoxNicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead late-stage development program is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa in the rest of the world. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX). For more information www.nicox.comAnalyst coverageH.C. Wainwright & Co Yi Chen New York, U.S. The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.Contacts NicoxGavin SpencerChief Executive OfficerT +33 (0)4 97 24 53 00communications@nicox.com DisclaimerThe information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.Risks factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2024” and in section 4 of the “Rapport semestriel 2025” which are available on Nicox’s website (www.nicox.com).Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.Nicox S.A.Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, FranceT +33 (0)4 97 24 53 00 Balance sheet(in thousands of euros)June 30, 2025December 31, 2024 ASSETS Intangible fixed assets1013Tangible fixed assets911Financial fixed assets703725 FIXED ASSETS722749 Trade receivables and related accounts1,0471,643Other receivables3,5269,349Cash assets5,70510,542Prepaid expenses1,7961,515CURRENT ASSETS12,07423,049 Unrealized foreign exchange losses and valuation differences – Assets1,50813Loan redemption premiums306610TOTAL REGULARISATION ACCOUNTS1,814623 TOTAL ASSETS14,61024,421 LIABILITIES Share Capital729692Premiums related to share capital534,264533,549Retained earnings(530,828)(508,438)Net loss for the financial year(8,948)(22,390) Total shareholders' equity(4,783)3,413 Provisions for liabilities1,50913Provisions for charges280268 Total provisions for liabilities and charges1,789281 Loans and debts from lending institutions14,81315,064Loans and other financial debts3382Accounts payable and related accounts1,4841,651Tax and social security debts414603Deferred income852735 Total current liabilities17,59618,135 Unrealized exchange gains and valuation differences - Liabilities82,592 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY14,61024,421 Income Statement(in thousands of euros)June 30, 2025June 30, 2024 Sales of services5262Sales of finished products1,0006,067 REVENUE1,5266,069 Reversals of depreciation, amortization, provisions and transfers of expenses-449Other income144105 TOTAL OPERATING INCOME1,6706,623 Other purchases and external charges(5,795)(6,853)Taxes, duties and similar payments(44)(42)Salaries and wages(590)(1,548)Social security expenses(253)(412)Amortization(5)(9)Impairment and provisions(12)-Other expenses(124)(1,247) TOTAL OPERATING EXPENSES(6,823)(10,111) OPERATING PROFIT (LOSS)(5,153)(3,488) Other interest and similar income373398Reversal of provisions, impairment losses and transfer of expenses-13Foreign exchange gains4623 TOTAL FINANCIAL INCOME419434 Amortization, depreciation and financial provisions(2,993)(383)Interest and similar expenses(546)(817)Foreign exchange loss(676)- TOTAL FINANCIAL EXPENSES(4,215)(1,200) FINANCIAL PROFIT (LOSS)(3,796)(766) PRE-TAX LOSS(8,949)(4,254) Exceptional income from previous financial year-3EXCEPTIONAL INCOME-3 Exceptional charges from previous fiscal year-(12)EXCEPTIONAL EXPENSES-(12) EXCEPTIONAL INCOME (LOSS)-(9) Research Tax credit-- NET PROFIT & LOSS(8,949)(4,263) Attachment EN_H12025_PR_FINAL

Financial StatementLicense out/inPhase 3

14 Oct 2025

·www.globenewswire.com

SpyGlass Pharma’s Novel BIM-IOL System Demonstrated a Statistically Significant Reduction in Mean IOP at 24 Months

42% reduction in mean intraocular pressure (IOP) compared to baseline (p<0.0001)100% of patients were off all topical IOP-lowering medications at 24 months100% of treated patients achieved 20/30 or better Best Corrected Distance Visual Acuity (BCDVA) at 24 months ALISO VIEJO, Calif., Oct. 14, 2025 (GLOBE NEWSWIRE) -- SpyGlass Pharma, a late-stage biopharmaceutical company, today announced interim 24-month data from its first-in-human trial of the Bimatoprost Drug Pad-IOL System (the BIM-IOL System). The BIM-IOL System, comprising novel, proprietary non-bioerodible drug pads attached to SpyGlass Pharma’s intraocular lens (IOL), is designed to be implanted during routine cataract surgery to reduce IOP in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The system is designed to consistently deliver multiple years of bimatoprost, a prostaglandin analog approved for the reduction of elevated IOP in patients with OAG or OHT. The interim clinical trial data demonstrated sustained improvements in IOP and visual acuity outcomes, underscoring the potential of the BIM-IOL System to transform care for OAG and OHT patients. “Adherence with daily topical IOP-lowering medications is one of the most consistent challenges for patients in the management of glaucoma and ocular hypertension,” said Malik Kahook, M.D., Co-founder of SpyGlass Pharma. “The findings at 24 months demonstrated that patients can achieve meaningful and durable reduction in IOP without the burden of daily drops. We are pleased to share these interim results and continue our objective of delivering a long-term, drop-free solution for patients in need.” The single-center, prospective first-in-human trial is designed to evaluate the BIM-IOL System for the treatment of elevated IOP in patients with OAG or OHT undergoing routine cataract surgery. At 24 months, the BIM-IOL System demonstrated: 42% reduction in mean IOP, from 25.1 ± 2.5 mmHg at baseline post-washout to 14.5 ± 3.0 mmHg (p<0.0001), with no statistically significant difference in IOP reduction across the three dosage groups tested.100% of patients were off all topical IOP-lowering medications.Best corrected distance visual acuity (BCDVA) improved to 20/30 or better in all patients. Overall, the BIM-IOL System was observed to be well-tolerated. All observed adverse events were considered to be related to the cataract procedure and none were deemed to be associated with the BIM-IOL System. No serious adverse events were observed. “The 24-month findings from our first-in-human trial add to our growing body of data supporting the long-term durability of the BIM-IOL System,” added Patrick Mooney, Chief Executive Officer of SpyGlass Pharma. “With an implantation technique familiar to all cataract surgeons, including the two-thirds of physicians who do not routinely perform minimally invasive glaucoma surgery, we believe our system has the potential to become a widely-implemented solution for reducing reliance on topical medication." ABOUT THE BIM-IOL SYSTEM SpyGlass Pharma’s lead product candidate, the BIM-IOL System, comprising novel, proprietary non-bioerodible drug pads attached to its intraocular lens, is 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 is planning initiation of two registrational Phase III clinical trials of the BIM-IOL System by end of year and continues long-term follow-up of patients in its first-in-human trial. SpyGlass Pharma completed enrollment in a Phase I/II study to investigate the safety and efficacy of the BIM-IOL System in a larger patient pool. SpyGlass Pharma plans to work with the FDA to advance the program through Phase III clinical trials, 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 redefine the management of these 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: www.spyglasspharma.com. Media Contact:Nami Surendranath+1 (212) 418-8981nsurendranath@dnacommunications.com Investor Contact:Ami Bavishi or Nick ColangeloGilmartin Group LLCinvestors@spyglasspharma.com

Clinical ResultPhase 3

100 Deals associated with Bimatoprost

External Link

KEGG	Wiki	ATC	Drug Bank
D02724	Bimatoprost	S01EE03	DB00905

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Glaucoma	Japan	Takeda Pharmaceutical Co., Ltd.	07 Jul 2009
Glaucoma	Japan	Senju Pharmaceutical Co., Ltd.	07 Jul 2009
Hypotrichosis	United States	AbbVie, Inc.	24 Dec 2008
Glaucoma, Open-Angle	United States	AbbVie, Inc.	16 Mar 2001
Ocular Hypertension	United States	AbbVie, Inc.	16 Mar 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hydrophthalmos	Phase 3	United States	Allergan UC	01 Sep 2011
Hydrophthalmos	Phase 3	France	Allergan UC	01 Sep 2011
Hydrophthalmos	Phase 3	Italy	Allergan UC	01 Sep 2011
Hydrophthalmos	Phase 3	Philippines	Allergan UC	01 Sep 2011
Hydrophthalmos	Phase 3	Taiwan Province	Allergan UC	01 Sep 2011
Hydrophthalmos	Phase 3	United Kingdom	Allergan UC	01 Sep 2011
Alopecia	Phase 3	Japan	Allergan UC	01 Jul 2011
Cataract	Phase 2	United States	SpyGlass Pharma Inc	13 Oct 2023
Androgenetic Alopecia	Phase 2	United States	Allergan UC	01 Jun 2011
Androgenetic Alopecia	Phase 2	Germany	Allergan UC	01 Jun 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06120842 (Tigris, GlobeNewswire) Manual	Phase 1/2	Ocular Hypertension	-	Bimatoprost	kslnxdxyae(dbyydrfnuf) = idmchyngyx zmyctvaybn (cxvqwiamds ) View more	Positive	14 Oct 2025
FDA_CDER Manual	Not Applicable	Glaucoma, Open-Angle \| Ocular Hypertension	-	0.01% ZOLYMBUS	qhqrhyykwo(yobpgmhtus) = OLYMBUS once daily (in the evening) was non-inferior to preserved bimatoprost ophthalmic solution 0.01%. qzjkvslnzg (uunfovgoop ) View more	Positive	09 Sep 2025
				0.01% preserved bimatoprost ophthalmic solution
NCT03850782 (TRITON, Pubmed \| Drugs)	Phase 3	Ocular Hypotension	441	Bimatoprost implant 10 µg	idgpqvpdan(vhydtihlny) = zitofqtljh lvaqqgmyrw (jhvgosuzvu, 369 - 485) View more	Positive	01 Apr 2025
NCT04747808 (BusinessWire) Manual	Phase 2	Glaucoma	-	LL-BMT1LL-BMT1 32-µg dose	jvhzkvgdsf(bkciklhvue) = jdpbytmhyw mturedypzz (cktavhilgq ) View more	Positive	12 Nov 2024
				bimatoprostbimatoprost 0.01%	-
NCT02507687 (CTgov)	Phase 3	Glaucoma, Open-Angle	240	SLT (Stage 2: SLT)	hobaqlyvef(ctbigvtvwy) = roxgjjlplc uqjqzayvec (udapskthvq, 0.28) View more	-	10 May 2024
				Bimatoprost SR (Stage 2: Bimatoprost SR 10 µg)	hobaqlyvef(ctbigvtvwy) = uerelcrxnc uqjqzayvec (udapskthvq, 0.28) View more
NCT03825380 (CTgov)	Phase 3	Glaucoma, Open-Angle \| Glaucoma	485	Bimatoprost (T4032)	bpujvjhrxo(lyfsudygav) = psdmimwbdp vbhqhshoia (uonqrgdhog, 0.19) View more	-	21 Nov 2023
				Lumigan® (Lumigan®)	bpujvjhrxo(lyfsudygav) = sfonbnemfp vbhqhshoia (uonqrgdhog, 0.18) View more
NCT04285580 (CTgov)	Phase 3	Glaucoma, Open-Angle	37	Bimatoprost SR (Bimatoprost SR 10 μg)	pdvrhylxom(izxtutzmco) = idvkjwhvyc qhdkwviuqm (cxdnorkbpa, 5.65) View more	-	08 Jun 2023
				LUMIGAN (LUMIGAN 0.01%)	pdvrhylxom(izxtutzmco) = slxrbzpzau qhdkwviuqm (cxdnorkbpa, 5.27) View more
NCT02250651 \| NCT01157364 \| NCT02247804 (Pubmed)	Phase 3	Ocular Hypertension \| Glaucoma, Open-Angle	-	Bimatoprost implant 10 µg	nvivutgfip(mwropqyslq) = agidwpfkka xvbaozaxqj (qxyhmwpwkp )	-	28 May 2022
				Topical timolol maleate 0.5%	nvivutgfip(mwropqyslq) = ovuteuuyoa xvbaozaxqj (qxyhmwpwkp )
NCT03850782 (Phase 3b Study, ARVO2022)	Phase 3	Ocular Hypotension	203	Bimatoprost implant	luzvqmuzpc(fjlytxmwqg) = tgfeihmcrk wjugpjilyb (dpaggoeuxa )	-	01 May 2022
ARVO2022	Not Applicable	Glaucoma	122	Bimatoprost SR implantation	almxxgwdmo(iybaccprid) = fwporrrlrv vhovzemmmc (mczfkelprj )	-	01 May 2022

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