With $36 Million, Visus Starts Phase II Trial of Presbyopia Drop Brimochol

In another sign of the intense interest in the category of presbyopia-correcting drops, Visus Therapeutics raised $36 million in Series A financing that will be used to advance its Brimochol clinical development program. The company’s lead asset is a proprietary combination of the cholinergic agent carbachol plus the alpha-2 agonist brimonidine, both Food and Drug Administration-approved, well-studied agents that work together to mitigate presbyopia by producing a “pinhole” or small-aperture effect that can last at least eight hours.

Johnson & Johnson Innovation – JJDC, RTW Investments, and Wille AG raised the round of cash, with additional participation from the company’s existing shareholders, Visus notes in a news release. “The investment from Johnson & Johnson Innovation – JJDC and others really marks a recognition of this emerging category of presbyopia-correcting eye drops,” Ben Bergo, Visus co-founder and CEO, told OIS Weekly.

Phase II Trial
Brimochol has entered a Phase II clinical trial, expected to enroll 40 patients with emmetropic phakic and pseudophakic presbyopia, to evaluate the safety and efficacy of two proprietary formulations of Brimochol. The primary endpoint is the percentage of patients gaining 3 lines or more in near visual acuity without losing distance vision.

“We expect to have top-line results from the Phase II at the end of Q2, and two Phase III studies enrolling over 500 patients will commence in Q3 of this year,” Bergo said. “Based on that data, we expect to file the NDA [new drug application] in Q3 of 2022, putting us on course for an approval in Q3 of 2023.”

The Presbyopia Market Opportunity
Presbyopia, almost universal in adults age 50 and older,¹ represents a huge market opportunity – around 123 million adults in the US alone.² Surveys find that patients are frustrated by presbyopia. Aside from glasses or contact lenses and surgery, few good treatments exist.

“Our research found that patients are extremely dissatisfied when they learn that the only immediate option for managing their presbyopia is reading glasses or potentially contact lenses,” Bergo said.

“As we talk to clinicians, investors, and others across the industry, we found that there is excitement around the prospect of a drop such as ours that can last a minimum of eight hours,” he added. “Patients want to be able to wake up, use the drop, and go through their workday without needing to continually re-drop. We designed the target product profile to ensure that we deliver to patients what they demand.”

Why Brimochol Is Different
Brimochol is differentiated from the pilocarpine-based agents in the pipeline by its combination formula. “Carbachol is a more potent miotic than pilocarpine, which provides a duration advantage,” Bergo said.

“Additionally, clinical data indicate that brimonidine mitigates some of the adverse effects of a straight miotic, such as hyperemia, headache, or brow ache, as well as the loss of distance visual acuity that comes with ciliary body contraction,” he added. “Fluctuations in IOP [intraocular pressure] can also occur with a miotic. The addition of brimonidine, therefore, seems to stabilize IOP, mitigate headache and brow ache, and even adds some whitening effects.”

Previously published data on 57 patients showed that patients treated with the combination achieved a mean 5 lines of near visual acuity improvement out to 12 hours with no complaints of headache or brow ache and no loss of distance vision.3 Bergo added that pharmacodynamic and pharmacokinetic studies indicate that brimonidine potentiates the effect of the carbachol.

“These factors clearly differentiate us, both from a side effect and tolerability profile versus the other miotic agents in development, but also in terms of achieving that long and durable response, which patients are looking for,” Bergo said.

References
1. US Census data. www.census.gov. Accessed March 31, 2021.
2. Market Scope. Global Presbyopia-Correcting Surgery Market Report. April 2012.
3. Abdelkader A. Influence of different concentrations of carbachol drops on the outcome of presbyopia treatment – A randomized study. Int J Ophthalm Res. 2019;5:317-320.