Sight Sciences Stock

Sight Sciences, Inc. operates as an ophthalmic medical device company focused on the development and commercialization of surgical and nonsurgical technologies for the treatment of prevalent eye diseases.

The company has focused its initial product development efforts on the treatment of two of the world’s most prevalent and underserved eye diseases, glaucoma and dry eye disease (DED).

OMNI is a handheld, single use, therapeutic device that allows ophthalmic surgeons to reduce IOP in adult glaucoma patients. SION is a bladeless, manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork, which is the tissue located near the cornea through which aqueous humor, or fluid, flows out of the eye.

OMNI allows the ophthalmic surgeon to sequentially complete two distinct, well-established but historically invasive ab externo glaucoma procedures, canaloplasty and trabeculotomy, in an efficient, minimally invasive manner using a single, bloodless and sutureless clear corneal microincision. The U.S. Food and Drug Administration (FDA) has cleared the use of OMNI for reducing intraocular pressure (IOP) in all adult primary open-angle glaucoma (POAG) patients both by itself on a standalone basis (Standalone procedures), or in combination with cataract surgery (Combination Cataract procedures).

OMNI’s indication for use was cleared by the FDA in March 2021 based upon the review of clinical data from ROMEO, the company’s U.S. multi-center clinical study of OMNI in Combination Cataract and Standalone procedures. OMNI has received 510(k) clearance from the FDA and a CE mark to be marketed in the U.S. and the European Union (EU) respectively, for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce IOP in adult patients with POAG in the U.S. or with open-angle glaucoma (OAG) in the EU. OMNI is cleared by the FDA to lower IOP in both Combination Cataract and Standalone cases for all adults with POAG. The company is pursuing an FDA Investigational Device Exemption (IDE), that would authorize it to conduct a clinical study, which it refers to as PRECISION, to assess the safety and effectiveness of a new, higher volume investigational OMNI device to perform canaloplasty alone to lower IOP in adults with POAG. The company is intending to conduct this canaloplasty-alone IDE trial to support a premarket notification to the FDA seeking clearance for use to perform canaloplasty-alone procedures in adults with POAG.

SION is registered with the FDA as a Class I 510(k) exempt device. SION allows the company to serve specific subsets of customers who may prioritize a faster or simpler procedure. The company’s target customers for SION include three types of combination cataract MIGS surgeons that are distinct from target OMNI customers, such as high volume cataract surgeons seeking to perform the quickest microinvasive glaucoma surgery (MIGS) procedures; surgeons who are initially less experienced with MIGS, such as surgical fellows at academic institutions; and surgeons looking for the most cost effective MIGS procedures in facilities that may emphasize procedural profitability.

The company primarily sells OMNI and SION in the U.S. through its dedicated Surgical Glaucoma sales team. The company’s commercial strategy for OMNI centers on building confidence and conviction among the glaucoma community through continued execution of its clinical trials and publication of their results in peer-reviewed journals. The procedure enabled by OMNI, canaloplasty followed by trabeculotomy, is covered and reimbursed by all Medicare Administrative Contractors (MACs) and numerous private insurers, covering an estimated 74% of medical benefit covered lives in the U.S. Designed for use in well-established clinical procedures, and with advantages that have been observed to promote safe, effective and highly consistent clinical outcomes, OMNI has the potential to establish a more proactive, interventional paradigm for IOP reduction in POAG. The company’s Surgical Glaucoma segment, which includes OMNI and SION, represented 92% of its total revenues for the year ended December 31, 2022.

TearCare is a unique open-eye heating and expression device designed to melt and remove meibomian gland obstructions. TearCare has a compelling physiological profile to address obstruction from meibomian gland disease (MGD), which is the primary cause of evaporative DED, a disease characterized by low quality tears that evaporate prematurely.

The company’s TearCare System is designed to enable eyecare professionals (ECPs) to heat and liquefy meibomian gland blockages, followed promptly by manual, comprehensive clearing of these blockages with a separate clearance tool. The company developed TearCare to serve as an elegant, compact, portable, and intuitive solution consisted of the SmartHub (SmartHub), a reusable hardware controller, and the TearCare SmartLids (SmartLids), a breakthrough, wearable, single-use software-controlled eyelid technology. Applied adhesively and non-invasively to the outside of the eyelids, single-use SmartLids deliver a precise therapeutic level of heat into the meibomian glands. Engineering SmartLids to remain comfortably adhered to virtually all shapes and sizes of eyelids while allowing freedom to blink and delivering precise therapeutic heat is one of the company’s most significant design accomplishments. This heating process follows clinically proven guidelines for temperature and duration required to melt obstructions in the glands and restore the production and secretion of healthy, clear meibum onto the tear surface. The proprietary, highly conformant, open-eye design of TearCare allows patients to blink naturally throughout the thermal portion of the procedure, which provides a comfortable patient experience. TearCare can be utilized by an ECP in a straightforward in-office procedure and can be accommodated during the course of a routine patient visit. Additionally, TearCare does not require a large capital equipment investment by ECPs, and it offers an attractive economic value proposition to providers, patients and third- party payors.

In OLYMPIA, the company’s large multi-center, randomized control trial (RCT), the TearCare procedure was associated with statistically significant clinical improvements in all assessed signs and symptoms of DED. This included tear breakup time (TBUT), and meibomian gland secretion score (MGSS), objective measurements of DED that were the trial’s primary endpoints, as well as patient-reported symptoms surveys, including Ehlers Danlos syndrome (EDS), ocular surface disease index (OSDI), and symptom assessment in dry eye (SANDE), at all time periods measured (both two weeks and four weeks post-treatment).

In December 2021, the FDA cleared TearCare for the application of localized heat therapy in adult patients with evaporative DED due to MGD, when used in conjunction with manual expression of the meibomian glands.

The company focuses on continuous innovation and seek regular input from its network of expert employees (including several ophthalmologists on staff), advisors and customers to rapidly iterate its pre- and post-commercial product designs with the aim of better satisfying the needs of its customers and their patients, and increasing adoption and utilization of its solutions.

Solutions

The company has designed OMNI, SION, and TearCare to be interventional ophthalmology devices.

OMNI Surgical System

OMNI is a handheld, single use, therapeutic device for MIGS. OMNI is designed to restore the eye’s natural drainage system without compromising the structural integrity of the eye or leaving implants behind post-surgery.

The company has applied its medical expertise, as well as specialized design and engineering capabilities, to create a complex device that is simple in appearance and intuitive to use. Each OMNI device consists of 29 separate precision-engineered parts that have been optimized for performance, effectiveness and usability.

SION Surgical Instrument

The company introduced SION in the third quarter of 2022. SION’s bladeless design, micro-engineered and precision manufactured using specialized lasers, excises tissue without cutting. SION grasps and removes diseased tissue as the surgeon sweeps the instrument around Schlemm’s canal with a single smooth motion. The bladeless technology of SION was developed with leading ophthalmic surgeons to improve safety and ease of use by eliminating the need to navigate sharp instrumentation within the eye’s anterior chamber and iridocorneal angle anatomy. SION represents the company’s third consecutive best-in-category device and satisfies the American Academy of Ophthalmology definition of goniotomy.

TearCare System

In an effort to address the treatment of evaporative DED due to MGD, the company’s custom designed TearCare to facilitate what is the optimal method for clearing meibomian gland obstructions based on numerous clinical studies: warming the glands to a minimum of 41 degrees Celsius for 15 minutes to melt congealed meibum followed by manual, clinician customized and performed removal of the liquefied obstructions using forceps to help facilitate restoration of healthy meibum production to naturally fortify the tear’s protective lipid layer.

The company’s TearCare System includes a pair of single-use SmartLids, the first wearable, highly conformant, precision heating device for the eyelids. SmartLids allow for eyes to be open and blink during the thermal portion of the process and are software-controlled, delivering precise heat to the tarsal plates of the eyelids directly overlying the meibomian glands while continuously monitoring temperature and communicating 144 times per second with the SmartHub, a compact, finely calibrated power source and control unit which can make instantaneous adjustments to ensure delivery of the desired amount of heat and therapeutic temperature level. Engineering SmartLids to remain comfortably adhered to virtually all shapes and sizes of eyelids while allowing freedom to blink and delivering precise therapeutic heat is one of the company’s most significant design accomplishments. Following therapeutic heat application by TearCare, ECPs may use forceps to manually express melted meibum from each gland. ECPs can tailor the amount of pressure applied during expression to specific glands based on a desired full evacuation of the glands, thereby allowing the eyelids to resume the production and secretion of meibum to coat and protect tears.

According to patient and ECP feedback, treatments using TearCare are comfortable for patients since they can keep their eyes open during the thermal portion of the procedure and have the freedom to blink naturally. Additionally, TearCare was designed to be administered during the course of a routine office visit to an ECP, which makes it convenient for patients, and allows providers to maintain procedural throughput in their practices.

Growth Strategy

The company’s growth strategies are to establish OMNI and SION as the standards of care for interventional glaucoma treatment among MIGS-trained surgeons; pioneer the standalone MIGS segment with OMNI; develop the MGD treatment market through a patient access-led strategy; drive adoption and utilization of its products by leveraging additional clinical trials and market education; deepen and broaden its commercial capabilities and expertise; expand into international markets; continuously innovate premium product offerings throughout eyecare; and obtain and maintain appropriate reimbursement coverage by governmental and commercial payors.

Clinical Data

The company is conducting active and robust clinical trial programs in both POAG and MGD. The company’s clinical trial designs include both RCTs, prospective, and retrospective real-world studies, based on its belief that each of these approaches has unique strengths. The company also plans to continue supporting its investigator-initiated trial program.

Commercial Approach

As of December 31, 2022, the company’s overall commercial team consisted of over 150 professionals dedicated to sales, marketing, commercial support, training and professional relations.

The company created distinct sales, marketing, and training teams for each of its business units because their products are predominantly sold to different types of customers and require specialized product specific sales expertise and ECP training to integrate its products into their practices. The company sells OMNI and SION to facilities where ophthalmic surgeons perform outpatient procedures, mainly ASCs and hospital outpatient departments (HOPDs). The company sells TearCare to optometry and ophthalmology practices. The company has also partnered with qualified ECPs to speak to peers on its behalf through educational forums either in-person or via virtual meetings.

Manufacturing

In January 2021, the company entered into a supply agreement with Peter’s Technology (Suzhou) CO LTD. (PTCS), a Chinese subsidiary of Peter’s Co., Ltd., a Taiwan-based contract manufacturer (the Peter's Supply Agreement). In February 2021, PTCS began to produce commercially saleable OMNI units for the company at its Suzhou City, China production facility. The initial three-year term of the Peter’s Supply Agreement expires January 14, 2024, and the agreement provides for automatic renewals of additional one-year periods if neither party provides notification that they intend to terminate the agreement within 90 days of the term ending. The company also has the right to terminate the agreement without cause during its term by providing 180 days’ advance written notice, or with 30 days’ written notice with any material agreement default by the manufacturer. The company subsequently amended the Peter’s Supply Agreement in January and November 2022 to, among other things, contract with PTCS to manufacture its SmartLids and SION surgical instruments.

Intellectual Property

Patents

As of December 31, 2022, the company owned 37 issued U.S. patents, 48 issued patents outside the U.S. (which included five issued European patents and their national validations), 19 pending U.S. non-provisional patent applications, 19 pending foreign patent applications and two pending Patent Cooperation Treaty patent applications. The company’s issued patents include claims directed to devices and methods for canaloplasty and/or trabeculotomy, ocular implants and related methods, the TearCare apparatus and methods of using the TearCare apparatus, components of the TearCare apparatus (including the SmartHub and SmartLids) and methods of their use, the TearCare apparatus in combination with an eyelid compression instrument and methods of their use, and methods of using the TearCare apparatus with patients wearing contact lenses.

Subject to payment of required maintenance fees, annuities, and other charges, the company’s issued U.S. patents have expiration dates between 2027 and 2041, with seven of its issued U.S. patents having expiration dates before 2030, 27 having expiration dates between 2031 and 2035, one having an expiration date in 2037, and the remaining two expiring in 2041, in each case exclusive of possible patent term extensions. Of the company’s 19 pending U.S. non-provisional patent applications, one was filed in 2018, two were filed in 2019, three were filed in 2020, five were filed in 2021, and eight were filed in 2022. The company’s pending U.S. non-provisional patent applications, if issued, have expected expiration dates between 2026 and 2042, exclusive of any possible patent term adjustments or patent term extensions.

The foreign jurisdictions where the company owns issued patents include Australia, Brazil, China, France, Germany, Hong Kong, Italy, Japan, Spain, Switzerland, and the United Kingdom. Subject to payment of required annuities and other charges, these foreign patents have expiration dates between 2027 and 2035. The company has pending patent applications in Australia, Brazil, Canada, China, Europe, and Japan, which if issued, have expected expiration dates between 2032 and 2040.

As of December 31, 2022, the company owned eight U.S. trademark registrations, one EU trademark registration, one German trademark registration, one Swiss trademark registration, one U.K. trademark registration, four pending U.S. trademark applications, two pending Brazilian trademark applications, and one pending application for an International Registration designating Australia, the European Union, Japan, Korea, Mexico, and Singapore.

Research and Development

The company’s research and development expenses were $22.9 million for the year ended December 31, 2022.

Government Regulation

The company’s products and its operations are subject to extensive regulation by the U.S. Food and Drug Administration (FDA) and other federal, state, and local authorities in the United States, as well as comparable authorities in foreign jurisdictions. The company’s products are subject to regulation as medical devices in the United States under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations. The company’s marketed OMNI and TearCare products are regulated as Class II devices subject to 510(k) clearance. The company’s SION surgical instrument is registered with the FDA as a Class I 510(k) exempt device.

In the United States, any products the company sells are required to be manufactured in compliance with the FDA’s Quality System Regulation (QSR), which covers the methods used in, and the facilities used for, the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of its products.

FDA regulations require the company to register as a medical device manufacturer with the FDA. The company’s certificates have been granted under the Council Directive 93/42/EEC, or the Medical Devices Directive. As a manufacturer, the company is subject to periodic scheduled or unscheduled inspections by the FDA.

History

Sight Sciences, Inc. was founded in 2010. The company was incorporated as a Delaware corporation in 2010.