Just under a year since receiving FDA approval, Orasis Pharmaceuticals has secured $78 million in financing to support the U.S. commercial launch of Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4%.
First things first: Orasis.
Founded in 2015—with U.S. headquarters in Ponte Vedra Beach, Florida—the ophthalmic pharmaceutical company is funded by a range of life science and healthcare investors, and is led by industry executives and eyecare specialists.
- Its focus: The development (and now pending commercialization) of Qlosi for presbyopia.
Let’s talk financing.
The Series D financing was co-led by Arboretum Ventures and Johnson & Johnson Innovation – JJDC, Inc. and included investments from:
- Catalio Capital Management
- Freepoint Capital Group
Prior investors of the company also participated in this round:
- Visionary Ventures
- Bluestem Capital
- SBI (Japan) Innovation Fund
- Sequoia Capital
- Maverick Ventures
Give me some numbers.
The financing comprised a $68 million equity component with Orasis also securing $15 million in structured capital (from Catalio Capital Management)—“of which $10 million will be drawn at closing,” the company reported.
- Total financing: $78 million
Any company input on this?
Orasis CEO Elad Kedar stated that the significant funding will enable the company to successfully launch Qlosi, “providing the eye care community a near-vision solution with a balance of efficacy and tolerability, using the lowest effective concentration of pilocarpine approved.”
Now about this product …
Qlosi—originally developed as CSF-1—is a preservative-free formulation of low-dose (0.4%) pilocarpine with a multi-faceted vehicle intended to reach an optimal balance between efficacy, safety, and comfort.
- Its indication: For the treatment of presbyopia in adults
- How it works: By improving near-visual acuity (VA) via pupil modulation—which creates a “pinhole effect” and results in an increase in the depth of field—and, ultimately, increasing the ability to focus on near objects.
And the dosing?
Per its prescribing information (PI), one drop of Qlosi should be topically administered in each eye.
Its efficacy: Anywhere from 20 minutes after administration and up to 8 hours.
- Note: This instillation can be repeated a second time 2 to 3 hours following the initial drops and used on a daily or as-needed basis (up to twice a day).
- Also: If using more than one topical ophthalmic medication, each must be administered at a minimum of 5 minutes apart.
When was it FDA-approved, again?
October 2023, becoming the anticipated second prescription drop in the U.S. indicated for presbyopia.
See our coverage—including a conversation between Glance President Jaclyn Garlich, OD, FAAO; Kader; and Orasis Chief Operating Officer (COO) Paul Smith.
Get into its clinical data.
Phase 3 data from two trials supporting the product’s approval reported that both studies met their primary and key secondary endpoints on Day 8, achieving a statistically significant 3-line or more gain in distance-corrected near VA (DCNVA) and no loss of 1-line or more in distance VA.
- Plus: On Day 15, participants achieved statistically significant 3-line or more improvement in DCNVA as early as 20 minutes and up to 8 hours post-dose 1.
Any precautions to be aware of prior to using?
To start, Qlosi’s PI notes the potential warnings and precautions:
- Blurred vision
- As well as temporary dim or dark vision
- Retinal detachment risk
- Rare occurrence
- Iritis
- Advised against use when present
- Contact lens wear
- Must be removed prior to drop instillation and only reinserted at least 10 minutes after dosing)
- Eye injury or contamination
- To prevent, avoid touching tip of the single-patient-use vial to the eye or any other surface
How about adverse reactions?
Based on clinical trial experience, the most common treatment-related adverse events (TRAE) reported among patients were instillation site pain and headache (5% to 8%).
As for ocular adverse reactions: A total of 2% to 5% of patients reported blurred vision.
- Important to note: The majority of reported AEs were “mild, transient, and self-resolving.”
Good to know … so when can we expect Qlosi to launch?
While the company has not yet named a specific launch date, eyecare professionals (ECPs) can sign up to receive updates and be “the first to know.”