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Orasis Highlights New Clinical Data Showing Qlosi’s Pupil-Selective Profile and Safety Edge in Presbyopia

Orasis Highlights New Clinical Data Showing Qlosi’s Pupil-Selective Profile and Safety Edge in Presbyopia

New updates have been reported about Orasis Pharmaceuticals.

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Orasis Pharmaceuticals has released new clinical data reinforcing the differentiated safety and mechanism-of-action profile of Qlosi (pilocarpine hydrochloride ophthalmic solution) 0.4%, its FDA-approved eye drop for presbyopia, with direct implications for market positioning and adoption. In an imaging study conducted by the Bascom Palmer Eye Institute and presented at the Hawaiian Eye & Retina 2026 Conference, Qlosi’s low-concentration pilocarpine significantly reduced pupil diameter—delivering the intended near-vision benefit—while showing ciliary muscle movement indistinguishable from a balanced salt solution (BSS) control, in contrast to 2% pilocarpine, which produced statistically significant ciliary muscle activation at near. This establishes, for the first time, that Qlosi’s 0.4% formulation is “pupil selective,” supporting near vision through the pinhole effect without materially engaging the accommodative apparatus, a point likely to be important for prescribers concerned about accommodative spasm and related adverse events.

CEO Elad Kedar emphasized that these findings align with real-world safety data since Qlosi’s launch, including no serious adverse events and no reported retinal detachments in the first 10 months of commercial use, reinforcing the company’s claim that formulation and concentration are key to balancing efficacy and safety. The study, based on thousands of high-resolution OCT images in presbyopic adults, supports Qlosi’s positioning as a low-concentration, preservative-free treatment designed for long-term use in a large and underpenetrated global presbyopia market of nearly two billion people. For Orasis, the data provide strong clinical ammunition to differentiate Qlosi from higher-concentration miotics, potentially improving payer and physician uptake, sustaining its safety-focused brand narrative, and supporting further commercial expansion in the U.S. and potentially ex-U.S. markets as the company engages its investor base and strategic partners around scaling its presbyopia franchise.

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