Aspen Pharmacare Australia will manage the distribution and marketing of the product, should it receive the green light from local regulators. The application relies on data from two pivotal Phase 3 trials, NEAR-1 and NEAR-2, which tracked over 600 adults. Participants in these studies achieved a statistically significant 3-line gain in distance-corrected near visual acuity by the eighth day of use, with minimal reported side effects.
Orasis Pharmaceuticals seeks Australian approval for presbyopia eye drop
Orasis Pharmaceuticals has reached a regulatory milestone by submitting a New Drug Application to Australia’s Therapeutic Goods Administration for its pilocarpine-based eye drop, branded as BESKA. The move marks the first international expansion for the treatment, which is already marketed as QLOSI in the United States.
Elad Kedar, CEO of Orasis, described the filing as a major step in broadening global access to non-invasive alternatives for reading glasses. The treatment utilizes the EyeQ Formulation, designed to improve near vision through pupil modulation, creating a pinhole effect that increases depth of field. Aspen anticipates a potential launch in Australia next year, aiming to integrate the drops into its existing portfolio of over 150 medical brands.
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