$25.62 -0.58 (-2.19%) As of 01:25 PM Eastern
This is a fair market value price provided by Massive. Learn more. We are 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. Our 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. 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. Disease progression after diagnosis is also common due to poor patient adherence to the current standard of care, which involves daily administration of IOP-lowering topical eye drop medications. For example, up to 80% of patients are non-compliant with their prescribed topical medications, and nearly 50% of patients discontinue use within one year(1). When topical medications fail to adequately control IOP, surgical intervention, such as minimally invasive glaucoma surgery (MIGS), may be recommended. While these procedures can help to manage IOP, they often require separate appointments with glaucoma specialists or cataract surgeons with specialized training. Out of the 10,000 cataract surgeons reported by MarketScope 2025 Global Glaucoma Device Report to be currently active in the United States, we estimate(2) that only one-third perform MIGS procedures routinely, which we define as at least two procedures per month. We believe that this low participation rate is due to several factors, including the need for specialized skills and training, technical discomfort, and workflow disruption. Taken together, we believe there is a significant unmet need for a long-term IOP-lowering therapy that is easy to administer and reduces reliance on patient adherence. The BIM-IOL System is designed to address key limitations of current glaucoma care by enabling all cataract surgeons, not just those trained in MIGS, to treat elevated IOP when performing their routine cataract procedures, thereby reducing the reliance on patient adherence to topical medications in managing IOP. The BIM-IOL System is designed for long-acting, sustained delivery of bimatoprost over three years, which we believe can reduce or eliminate the need for daily topical medications. In addition, we believe our BIM-IOL System has the potential to triple the number of cataract surgeons that treat OAG or OHT routinely at the time of cataract surgery by providing a solution that seamlessly integrates into the existing procedural workflow. This integration of therapy at the time of cataract surgery–one of the most frequently performed outpatient procedures in ambulatory surgery centers (ASCs) in the United States(3)–can also save patients from having to make additional appointments with glaucoma specialists. By combining a known drug (bimatoprost), a known procedure (cataract surgery), and a known device type (IOL), the BIM-IOL System aims to deliver a solution that addresses both cataracts and elevated IOP in a single, streamlined intervention. We believe this approach positions us to pursue a streamlined regulatory approval process under the FDA’s 505(b)(2) pathway because the active ingredient in our BIM-IOL System, bimatoprost, has been previously approved by the FDA. In general, new drug products, including drug-led combination products, can come to the market in the United States through two FDA regulatory pathways: 505(b)(1) or 505(b)(2). We note that for drug products, including drug-led combination products, where the active ingredient has been previously approved by the FDA or where there is published safety or effectiveness data that can be leveraged to support an NDA, the 505(b)(2) pathway can potentially be used to streamline the development process. We believe our approach is consistent with regulatory guidance from the FDA and we have communicated our strategy to seek approval via the 505(b)(2) pathway to the FDA. The FDA will ultimately determine our regulatory pathway following the submission of our 505(b)(2) NDA. We anticipate that use of the BIM-IOL System, if approved, will be reimbursed through established reimbursement pathways, including Medicare Part B coverage, and we intend to leverage existing Category I Current Procedural Terminology (CPT) codes for the cataract surgery and apply for a new J-code for the physician-administered drug. By supporting the treatment of two common conditions in a single intervention, we believe our BIM-IOL System could offer a compelling solution that can potentially enhance patient outcomes, simplify care delivery, and support provider economics. We estimate that the total addressable market in the United States for the BIM-IOL System is approximately $13 billion based on the estimated one million glaucoma and OHT patients expected to undergo cataract surgery in 2025(4), the percentage of patients with glaucoma who have OAG(5) and the wholesale acquisition cost for iDose TR. We aim to disrupt and expand the well-established glaucoma market by addressing two critical unmet needs: long-term therapeutic durability and improved patient adherence. We were incorporated in Delaware in January 2019. Our principal executive offices are located in Aliso Viejo, California.
