Headwinds and Tailwinds of Building a Biotech

Launching a company is a challenging endeavor, but when we founded Visus Therapeutics in 2019, we had no idea of the world-wide changes ahead. The idea that a virus was about to upend the world and invalidate traditional business models was unfathomable.?As an entrepreneur, husband, father, and avid cyclist, I’ve never been one to shy away or turn back when headwinds mount, even when I’m not exactly sure how the journey to the top will look. Two years ago, I knew speed bumps were inevitable, but I remained confident and trusted that as long as we persevered, we would succeed.

Visus Therapeutics is committed to dramatically improving patient lives through the development of best-in-class ophthalmic therapies. Visus’ first challenge was to begin advancing our lead investigational asset for the treatment of presbyopia, BRIMOCHOL? PF. To date, presbyopia treatment options remain limited. Presbyopia, the loss of near vision associated with aging and making it difficult to perform tasks like reading fine print, impacts approximately 128 million U.S. adults. [1],[2]

Ramping Up and Making Headway

We began by developing and testing multiple formulations in preclinical studies to generate pupil constriction data before moving into the clinic. I remember when Rhett Schiffman, our Chief Medical Officer and co-founder, called me whilst I was riding up a local hill to explain that the first study data was promising and correlated with prior clinical data. Our first formulations appeared to generate a better-than-expected response and boded well for our combination drug therapy.

Eighteen months later, we completed our first clinical study, a Phase 2 crossover design testing three long-acting formulations. Our Phase 2 data demonstrated that the two preservative-free formulations, BRIMOCHOL? PF and Carbachol PF, were well tolerated and met clinical outcomes to progress into ongoing pivotal Phase 3 trials. Our two Phase 3 studies will advance our goal of achieving a durable response of over 8 hours, which is what people living with presbyopia are expecting with presbyopia-correcting eye drops. Reaching a durable response of over 8 hours would entirely reset the expectations of the category for presbyopia-correcting eye drops, and we are well on our way to doing so.

We see this category dividing along the lines of duration. Market research studies have demonstrated the need for a long-acting, once daily eye drop that lasts the workday. A study of over 500 people who are experiencing presbyopia in the U.S. showed that more than 70% would switch to a longer-acting drop if it provided one more hour of benefit.[3] As we continue to evaluate BRIMOCHOL? PF and Carbachol PF, we expect to achieve a duration of more than 8 hours, providing significant benefits over shorter-acting eye drops.

Eyes on the Road Ahead for Patients and Visus Therapeutics

As fellow cyclists know, the general classification riders in the Grand Tours are those racers who excel across disciplines and have teams that empower them to pedal through any challenge. Similarly, Visus recognizes the importance of being a versatile clinic-stage biopharmaceutical company focused on bringing different innovations to market to address significant unmet needs. We have a large, growing patent portfolio covering early-stage ophthalmic drug candidates with applications in corneal wound healing, glaucoma, and age-related macular degeneration.

Cycling has taught me many life lessons, one being that no leader can work alone and those who try are doomed to fail. Visus has worked hard to recruit the best talent in the field – from our leadership team and board of directors to advisors and hard-working employees. We’ve given ourselves a head start with the best and brightest who have hundreds of cumulative years of experience in the eye care field. We’ve also gained the confidence of investors who share our vision and partner to optimize value creation.

The last two years have been a wild ride. We’ve learned to be nimble and adaptable as we navigated the unexpected. While some may fear the unexpected, I think it makes life more interesting. In the words of famed German long-distance cyclist Heinz Stücke, “It is the unknown around the corner that turns my wheels.”

[1] Zebardast et al. The Prevalence and Demographic Associations of Presenting Near-Vision Impairment Among Adults Living in the United States. Am J Ophthalmol. 2017;174:134-144.

[2] U.S. Census Bureau. Table 9. Washington: Population Division. 2014.

[3] Visus Therapeutics data on file: Burke Healthcare Research, April 2020.