Visus Therapeutics Hosts Inaugural Capital Markets Day in New York City

Company executives and eye care experts discussed therapeutic utility and commercial potential for BRIMOCHOL™, an investigational eye drop for the treatment of presbyopia

Physician and consumer research underscores efficacy and duration of action are key market drivers for presbyopia-correcting eye drops

Renowned industry experts highlighted company’s new drug candidates under investigation for corneal wound healing, glaucoma and geographic atrophy due to age-related macular degeneration, and a novel sustained-release drug delivery platform

SEATTLE--(BUSINESS WIRE)--Visus Therapeutics Inc., a clinical-stage pharmaceutical company focused on developing innovative ophthalmic therapies to improve vision for people around the world, recently welcomed investors, analysts and media to its inaugural Capital Markets Day in New York City. Visus Therapeutics’ management team and some of the world’s leading eye care experts presented new information on the company’s lead asset, BRIMOCHOL™, an investigational drug designed to be a once-daily eye drop to correct for the loss of near vision associated with presbyopia. Visus Therapeutics leadership also unveiled additional ophthalmic drug candidates with applications in development for corneal wound healing, glaucoma and age-related macular degeneration (AMD). Additionally, the company introduced a novel drug delivery platform licensed from DelSiTech that has the potential to help optimize the clinical benefit of ophthalmic therapies.

“Expanding our portfolio of investigational drug therapies to address diseases in both the front and the back of the eye positions Visus Therapeutics to achieve meaningful breakthroughs in areas of significant unmet need,” said Ben Bergo, co-founder and chief executive officer at Visus Therapeutics. “These new assets coupled with DelSiTech’s innovative drug delivery platform have the potential to transform treatment paradigms in pursuit of helping millions of patients worldwide.”

BRIMOCHOL is Poised to Address Key Unmet Needs in Presbyopia Eye Drop Category

Renowned eye care experts Zaina Al-Mohtaseb, M.D., Associate Professor in the Ophthalmology Department at Baylor College of Medicine, and April Jasper, O.D., owner of Advanced Eyecare Specialists in West Palm Beach, Florida, participated in a panel discussion regarding presbyopia and pharmacologic treatment options. Moderated by Carey Powers, vice president of marketing at Visus Therapeutics, key takeaways included:

• The physicians shared their observations on the impact of presbyopia on quality of life for their patients, noting that in a recent market research survey, consumers reported that presbyopia has a profound impact on quality of life, more than other common age-related ailments such as hearing loss, arthritis and high blood pressure. Dr. Al-Mohtaseb noted that presbyopia is not just a personal problem, but also a societal problem, resulting in a decrease in annual global productivity of approximately $11 billion to $25 billion dollars.¹
• Dr. Al-Mohtaseb and Dr. Jasper commented that prescribers are likely to be receptive to the presbyopia drops category as a result of eye care professionals’ (ECPs) familiarity and comfort level with the active ingredients’ safety profiles due to their longstanding use for treating glaucoma.
• Both physicians agreed that efficacy and duration of action will be key deciding factors in the minds of patients, with patients on the earlier side of presbyopia in their 40s and 50s being the most enthusiastic adopters of the treatment option.

To further demonstrate the demand for the presbyopia category, Haejin Shin, Principal at IQVIA Strategic Advisory Services, presented new research based on the firm’s presbyopia landscape assessment, as well as primary insights from ECPs. Key findings discussed include:

• The estimated addressable population for presbyopia-correcting drops in the U.S. is between 70-90 million.²
• The main drivers for market uptake and adoption for presbyopia-correcting eye drops will be efficacy and treatment duration, with most ECPs preferring a drop that lasts at least eight hours. ²
• Approximately half of the ECPs highlighted the value of a preservative-free eye drop option for patients with dry eye disease. ²

Carey Powers presented market research findings from more than 1,500 U.S. consumers and 200 consumers in China reporting there is broad appeal for presbyopia-correcting drops across a wide range of demographics.³ Powers noted the most valuable customer segment will likely be working professionals in their 40s and 50s, with seven in 10 preferring a drop that lasts a minimum of seven hours.³ A majority of consumers expect to use the drops five to seven times per week.³

Investigational Ophthalmic Therapies Have Potential to Disrupt Treatment Paradigms

In addition to BRIMOCHOL, Visus Therapeutics is advancing an array of investigational compounds to treat a range of diseases in the front and the back of the eye. The company’s preclinical candidate, VT-201, belongs to a class of salivary and lacrimal peptides called histatins and has potential applications for corneal wound healing, including post-surgical care and treatment for ocular surface disease.

Dr. Eric D. Donnenfeld, Founding Partner, Ophthalmic Consultants of New York and Ophthalmic Consultants of Connecticut, and Clinical Professor of Ophthalmology, New York University Medical Center, discussed the clinical utility of histatins, such as VT-201, as potential treatments for ophthalmic conditions. He noted that histatins’ rapid wound healing, anti-inflammatory and anti-microbial properties may help treat ocular surface diseases.

“Histatins appear to me to be one of the most extraordinarily disruptive opportunities that I have seen in ocular surface disease in my career, and this is an exciting technology that we look forward to the development of over the next few years,” said Dr. Donnenfeld. “As a corneal specialist, I am extremely interested in the development of these medications. If this technology turns out to be as disruptive as I believe it will be, it will transform the way we practice ophthalmology and improve patient care.”

Through a worldwide exclusive licensing agreement with Cella Therapeutics, Visus Therapeutics’ drug development pipeline has expanded to include a number of investigational drug candidates (VT-301, VT-401 and VT-501) intended to treat glaucoma and age-related macular degeneration (AMD), two of the leading causes of blindness globally.⁴ Through another worldwide exclusive licensing agreement, Visus Therapeutics will utilize a biodegradable, silica-based, sustained-release technology from DelSiTech Ltd. to develop these compounds as intraocular treatments that could last six months or more and potentially overcome many limitations of currently available ophthalmic therapies.

VT-301 is a novel, injectable, sustained-release delivery system that delivers Bimatoprost Acid directly to the vitreous body to potentially help manage intraocular pressure (IOP). VT-401, which combines Bimatoprost Acid and a CNTF analog compound, has the potential to not only control IOP and prevent further vision loss, but may also help improve vision in some glaucoma patients.

Leading glaucoma expert Dr. Ike Ahmed of the Prism Eye Institute, GAASS Fellowship Director, Kensington Eye Institute, University of Toronto and Professor, University of Utah, discussed VT-301 and VT-401 with the DelSiTech platform: “The ability to combine the pressure lowering potential of Bimatoprost Acid with the addition of CNTF for neuroprotection in a biodegradable sustained-release formulation addresses the biggest unmet needs in glaucoma treatment today – issues around patient compliance and the control of pressure fluctuations that occurs with topical drops, and neuroprotection. Visus Therapeutics’ potential multi-modal approach can address the challenges and large unmet needs in glaucoma treatment today for patients.”

Rhett Schiffman, MD, MS, MHSA, co-founder, chief medical officer and head of research and development at Visus Therapeutics, explained the biological processes that lead to geographic atrophy, a leading cause of irreversible blindness affecting 2.6 million people in the U.S., Europe and Japan.⁵ Geographic atrophy develops when programmed cell death pathways are activated in retinal cells. This loss of cells eventually creates a hole in the retina, forming a blind spot in the center of a person’s vision. “One of the main complaints from patients who have this is that they can't see the faces of their loved ones, their kids or grandkids, so this is really, really devastating for them,” noted Dr. Schiffman. There is currently no approved treatment for geographic atrophy, and other investigational treatments only modestly slow its progression.

The company’s new investigational candidate, VT-501, combines cell death signaling inhibitors with neurotrophic factors that promote cell survival to reduce retinal cell loss, and potentially enhance function in patients with AMD. Dr. Schiffman added, “VT-501 injected intravitreally using the DelSiTech platform may overcome the extreme biological redundancy that promotes unrelenting cell death in the eye.”

Dr. Schiffman underscored how Visus Therapeutics’ expanding drug development and delivery program will drive the company’s efforts to develop best-in-class therapies to improve vision for people around the world, stating: “The synergistic nature of Cella Therapeutics’ novel, investigational candidates for glaucoma and AMD in combination with DelSiTech’s innovative drug delivery technology has the potential to yield profound advancements in the treatment of these very serious eye diseases. The addition of these assets to the Visus Therapeutics portfolio enables our seasoned team of scientists to harness their collective expertise in pursuit of improving patient outcomes.”

About BRIMOCHOL

BRIMOCHOL is a proprietary, pupil-modulating eye drop that combines two well-studied, FDA-approved pharmaceuticals: carbachol (a cholinergic agent) and brimonidine tartrate (an alpha-2 agonist). Together, they produce a durable “pinhole effect,” which reduces the size of the pupil so that only centrally focused light rays can enter the eye, thereby sharpening distant and near images while minimizing side effects. The result is clarity of vision for near tasks like reading or using a smartphone. This patented combination eye drop has been studied in more than 200 patients in six successfully completed clinical studies. Two formulations, BRIMOCHOL and BRIMOCHOL-F, are being studied in Phase 2 clinical trials. Topline data from the company’s Phase 2 trial evaluating BRIMOCHOL are expected later in 2021, and pending affirmative results, Phase 3 pivotal studies will immediately follow.

About Visus Therapeutics

Visus Therapeutics is a clinical-stage pharmaceutical company focused on developing innovative ophthalmic therapies to improve vision for people around the world. With offices in Seattle, WA and Irvine, CA., its lead clinical candidate is BRIMOCHOL, an investigational drug designed to be a once-daily eye drop to correct for the loss of near vision associated with presbyopia. In parallel, Visus Therapeutics is focused on advancing its pipeline of early-stage ophthalmic product candidates with applications in ocular surface disease, glaucoma, and age-related macular degeneration. For more information, visit: www.visustx.com and follow us on LinkedIn, Twitter (@VisusTx) and Instagram.

The video of the presentations from the Visus Therapeutics Capital Markets Day is available here on the Visus Therapeutics web site.

¹ Berdahl J, et al. Patient and Economic Burden of Presbyopia: A Systematic Literature Review. Clinical Ophthalmology. 2020 Oct 22;14:3439-3450. https://pubmed.ncbi.nlm.nih.gov/33116396/ Accessed Sept. 10, 2021.
² Visus Therapeutics data on file: IQVIA Presbyopia Landscape Assessment, July 2021.
³ Visus Therapeutics data on file: Burke Healthcare Research, April 2020.
⁴ Basics of Vision and Eye Health. (2020, June 3). Centers for Disease Control and Prevention. https://www.cdc.gov/visionhealth/basics/ced/index.html#a6
⁵ GlobalData (2017). PharmaPoint: Age-Related Macular Degeneration – Global Drug Forecast and Market Analysis to 2026.

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