Submission of New Drug Application (NDA) in Australia by Aspen Pharmacare Australia (Aspen Australia) marks the first ex-U.S. regulatory submission (known as QLOSI^® in the U.S.)

/PRNewswire/ - Orasis Pharmaceuticals and Aspen Australia announced that Aspen has submitted a New Drug Application in Australia to the Therapeutic Goods Administration (TGA) for the review and approval of BESKA (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults (known as QLOSI in the US market). Aspen will be responsible for the distribution and marketing of BESKA in Australia.

The NDA submission was supported by positive data from two pivotal Phase 3 clinical trials NEAR-1 and NEAR-2 which evaluated the efficacy safety and tolerability in more than 600 adult patients with presbyopia. Both trials met their primary and key secondary endpoints on Day 8 achieving statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA) and no loss of 1-line or more in distance visual acuity. All adverse events reported were in the single digits with headache (6.8%) and instillation site pain (5.8%) being the most commonly reported treatment-related adverse events (TRAEs).

"We are excited about this important milestone as we work with trusted partners to expand the availability of our treatment for presbyopia in additional markets around the world" said Elad Kedar Chief Executive Officer of Orasis Pharmaceuticals. "We know Aspen's highly experienced team is well-positioned to work with local regulators to gain approval and ultimately to commercialize Qlosi with the trademark BESKA in Australia bringing to eye care providers a flexible option for their presbyopia patients seeking an alternative to reading glasses."

"Aspen is proud to have completed the submission for Beska in Australia. This product is a great enhancement to our existing portfolio as we seek to improve the visual health and quality of life in the communities we serve. We look forward to the continued collaboration with Orasis Pharmaceuticals as we prepare for the approval and launch next year" said Trevor Ziman Regional Chief Executive Asia Pacific.

About PresbyopiaPresbyopia is the loss of ability to focus on near objects as a result of the natural aging process. It occurs mostly after the age of 40 when the crystalline lens of the eye gradually stiffens and loses flexibility. There are almost two billion people globally and more than 128 million people in the U.S. living with presbyopia. People with presbyopia experience blurred vision when performing daily tasks that require near visual acuity such as reading a book a restaurant menu or messages on a smartphone. Presbyopia cannot be prevented or reversed and it continues to progress gradually. Many existing treatment options can be either cumbersome or invasive presenting a significant unmet need for presbyopia patients. Presbyopia can be diagnosed during an eye exam conducted by an eye care professional.

About Qlosi/BeskaQlosi/Beska (pilocarpine hydrochloride ophthalmic solution) 0.4% is a novel prescription eye drop approved in the U.S. for the treatment of presbyopia in adults. Beska is not approved in Australia yet but an NDA has been submitted and accepted for review and approval by the TGA. Qlosi's EyeQ Formulation delivers the lowest effective concentration of pilocarpine approved in a preservative-free eye drop with a near-neutral pH and dual lubricating agents to provide enhanced safety and patient comfort without compromising on efficacy. Qlosi improves near visual acuity by pupil modulation resulting in a "pinhole effect" and an increase in the depth of field thus increasing the ability to focus on near objects without negatively impacting distance vision. In clinical trials the most commonly reported treatment-related adverse events (TRAEs) were headache and instillation site pain at rates of 6.8% and 5.8% respectively. For more information visit the company website and follow us on LinkedIn Facebook and Instagram.

About Orasis PharmaceuticalsOrasis Pharmaceuticals is an ophthalmic pharmaceutical company delivering solutions to reshape vision possibilities. Orasis has developed Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% a novel corrective prescription eye drop for the treatment of presbyopia or age-related blurry near vision in adults. Orasis is led by a collaborative team of industry executives and eye care professionals working to transform the standard of care for near vision correction. Orasis is funded by a diverse group of sophisticated and experienced life science and healthcare investors. Orasis has offices in the United States and Israel. For more information visit the company website and follow us on LinkedIn.

About Aspen Pharmacare Australia PharmaceuticalsAspen Pharmacare Australia is one of Australia's leading pharmaceutical companies dedicated to improving health and quality of life in the communities it serves through a diverse portfolio of over 150 prescription and over the counter (OTC) medicine brands. Since commencing operations in Australia in 2001 the company has grown rapidly through strategic acquisitions and partnerships serving both Australia and New Zealand with high-quality accessible medicines.

Qlosi U.S. Indication and Important Safety Information

Indication and UsageQlosi (pilocarpine hydrochloride ophthalmic solution) 0.4% for topical ophthalmic use is a cholinergic agonist indicated for the treatment of presbyopia in adults.

Important Safety Information

CONTRAINDICATIONS

Hypersensitivity

WARNINGS AND PRECAUTIONS

Advise patients to not drive or operate machinery if vision is not clear (e.g. blurred vision). Exercise caution in night driving and other hazardous occupations in poor illumination.
Rare cases of retinal detachment have been reported with miotics. Examination of the retina is advised in all patients prior to initiation of therapy. Advise patients to seek immediate medical care with sudden onset of flashes of lights floaters or vision loss.
Qlosi is not recommended to be used when iritis is present.
Qlosi should not be administered while wearing contact lenses. Remove lenses prior to the installation of Qlosi and wait 10 minutes before reinsertion.
Avoid touching the tip of the vial to the eye or any other surface.

ADVERSE REACTIONS

The most common adverse reactions (5% to 8%) are instillation site pain and headaches.

Please see full Prescribing Information on the company site.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA medwatch site or call 1-800-FDA-1088.

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References:

¹ Holland E Karpecki P. Fingeret M. et al. Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized Clinical Trials. Clin Ther. 2024;46(2):104-113. doi:10.1016/j.clinthera.2023.12.005.

² Holden B. A. et al. Global Vision Impairment Due to Uncorrected Presbyopia. Arch Ophthalmol. 2008;126(12):1731-1739.

³ U.S. Census Bureau. United States Census - Populations and People. Accessed January 26 2026.

⁴ WebMD. Presbyopia: Symptoms diagnosis and treatment. Accessed January 26 2026.

⁵ U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed January 26 2026.

⁶ Qlosi [package insert]. Ponte Verda FL. Orasis Pharmaceuticals.

SOURCE ORASIS PHARMACEUTICALS