Orasis Pharmaceuticals and Aspen Submit New Drug Application in Australia for BESKA (Pilocarpine HCl 0.4%) for Presbyopia
核心洞察
Orasis Pharmaceuticals (搜索) and Aspen Pharmacare Australia (搜索) have submitted a New Drug Application to the TGA for BESKA (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia (搜索) in adults.
The submission marks the first ex-U.S. regulatory filing for the product, which is marketed as QLOSI in the United States and has already received FDA approval.
The NDA is supported by data from two pivotal Phase 3 trials, NEAR-1 and NEAR-2, involving more than 600 patients, with both trials meeting primary and key secondary endpoints.
Orasis Pharmaceuticals (搜索), in partnership with Aspen Pharmacare Australia (搜索), announced on July 15, 2026, the submission of a New Drug Application (NDA) to Australia's Therapeutic Goods Administration (TGA) for BESKA (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia (搜索) in adults. The product, known as QLOSI in the U.S. market, represents the first regulatory submission for this therapy outside the United States. Aspen will assume responsibility for distribution and marketing of BESKA in Australia upon approval.
"This is an important milestone as we work with trusted partners to expand the availability of our treatment for presbyopia (搜索) in additional markets around the world," said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals (搜索). "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."
Trevor Ziman, Regional Chief Executive Asia Pacific at Aspen, added: "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 (搜索) as we prepare for the approval and launch next year."
Phase 3 Clinical Evidence Supporting the Submission
The NDA submission is underpinned by positive data from two pivotal Phase 3 clinical trials, NEAR-1 and NEAR-2, which evaluated the efficacy, safety, and tolerability of the investigational therapy in more than 600 adult patients with presbyopia (搜索). Both trials met their primary and key secondary endpoints on Day 8, demonstrating a statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA) with no loss of 1-line or more in distance visual acuity.
The safety profile was notable for its tolerability, with all adverse events reported in the single digits. The most commonly reported treatment-related adverse events (TRAEs) were headache at 6.8% and instillation site pain at 5.8%.
Mechanism of Action and Formulation
BESKA/QLOSI employs Orasis's proprietary EyeQ Formulation, which delivers the lowest effective concentration of pilocarpine approved in a preservative-free eye drop. The formulation features a near-neutral pH and dual lubricating agents designed to provide enhanced safety and patient comfort without compromising efficacy. The therapy improves near visual acuity through pupil modulation, producing a "pinhole effect" that increases the depth of field, thereby enhancing the ability to focus on near objects without negatively impacting distance vision.
The Presbyopia Treatment Landscape
Presbyopia (搜索), the age-related loss of near vision, affects almost two billion people globally and more than 128 million people in the United States alone. The condition typically manifests after age 40 as the crystalline lens gradually stiffens and loses flexibility. People with presbyopia experience blurred vision when performing daily tasks requiring near visual acuity, such as reading books, restaurant menus, or smartphone messages. The condition cannot be prevented or reversed and continues to progress gradually. According to Orasis, many existing treatment options remain either cumbersome or invasive, presenting a significant unmet need for patients.
Safety Considerations
In the U.S., QLOSI carries warnings regarding potential visual disturbances, with patients advised not to drive or operate machinery if vision is unclear. Rare cases of retinal detachment have been reported with miotics, and retinal examination is advised prior to therapy initiation. The product is not recommended for use when iritis is present and should not be administered while wearing contact lenses. The most common adverse reactions, occurring at rates between 5% and 8%, are instillation site pain and headaches.