(Incorporated in Delaware)

We are a late-stage biopharmaceutical company dedicated to transforming the treatment paradigm for patients living with chronic eye conditions – specifically, open-angle glaucoma (OAG) or ocular hypertension (OHT) – through long-acting sustained drug delivery of approved medicines. Our mission is to significantly improve the lives of these patients by developing durable drug delivery solutions that can empower them and their surgeons with confidence in long-term disease control and vision preservation.

Our lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), comprising novel, proprietary drug pads attached to our intraocular lens (IOL), 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 three years of bimatoprost, a prostaglandin analog (PGA) approved for topical use by the U.S. Food & Drug Administration (FDA) in 2001 for the reduction of elevated IOP in patients with OAG or OHT.

We are also developing a non-IOL-based, ring-shaped, sustained-release implant with bimatoprost, which we believe could be implanted in a standalone procedure, enable retreatment of patients who have received the BIM-IOL System, and offer extended care to patients with OAG or OHT who already received a prior cataract surgery (these patients who have had their IOLs replaced with artificial IOLs are referred to as pseudophakes or pseudophakic patients).

In our first-in-human (FIH) feasibility clinical trial, evaluable patients who received the BIM-IOL System achieved a mean IOP reduction of 37% at 36 months with no product-related adverse events (AEs). 95% of evaluable patients were off all topical IOP-lowering drops at 36 months, which we believe highlights the potential for long-term independence from such medications. In our Phase 1/2 multicenter, randomized, controlled trial, which is evaluating the safety and efficacy of the BIM-IOL System, patients who received the BIM-IOL System in the 78 mcg and 39 mcg dose groups achieved mean IOP reductions of 37% and 36%, respectively, with 97% of treated patients off topical IOP-lowering drops at three months, and the BIM-IOL System was observed to be well tolerated. Based on our encouraging data to date, we initiated two registrational Phase 3 trials in July 2025, each expected to enroll approximately 400 patients across 45 sites.

We expect to complete enrollment in 2027 and, pending successful Phase 3 results, we plan to submit a 505(b)(2) New Drug Application (NDA) to the FDA in 2028. There is no guarantee that our trials will produce positive results or be consistent with past trial results, and FDA approval is not guaranteed and the regulatory process may take longer than anticipated.

Glaucoma is a chronic, progressive disease that is primarily caused by impaired drainage of aqueous humor–the fluid inside the eye–which can lead to elevated IOP. Sustained elevation of IOP can damage the optic nerve, resulting in permanent vision loss. Despite the availability of numerous medical and surgical interventions, glaucoma remains a leading cause of irreversible blindness. Glaucoma is often asymptomatic and frequently undiagnosed until significant vision loss has occurred. 

(Note: SpyGlass Pharma, Inc. filed its S-1 for its IPO on Jan. 16, 2026, without disclosing the terms. Estimated proceeds are $100 million, but that is a placeholder figure.)