Orasis Pharmaceuticals announced the FDA approval of QLOSI (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia.
Tell me more about this drug.
Originally developed under the name CSF-1, QLOSI (pronounced CLOH-see) is a preservative-free formulation of low-dose pilocarpine with a multi-faceted vehicle designed to achieve an optimal balance between efficacy, safety, and comfort.
Orasis Pharmaceuticals CEO Elad Kedar and President/COO Paul Smith spoke with Glance President Jaclyn Garlich, OD, FAAO, on the launch.
What’s the recommended dosage?
Per the drug’s prescribing information, one drop in each eye can be used daily or as needed (with dosings up to twice a day, 2 to 3 hours apart).
To note, if using more than one topical ophthalmic medication, each must be administered at least 5 minutes apart.
See here for the complete prescribing info.
How does it work?
QLOSI can improve near visual acuity by modulating pupil size, resulting in a "pinhole effect" and an increase in the depth of field—thus potentially increasing the ability to focus on near objects.
To note: administration while wearing contact lenses is not recommended; lenses should be removed prior to instillation and reinserted at least 10 minutes afterward.
And for how long?
Efficacy has been demonstrated 20 minutes after administration, lasting up to 8 hours (as measured on Day 15) to improve near vision without affecting distance or night vision.
Gotcha. What’s the clinical data on it?
The approval is based on the multi-center, randomized, double-masked, vehicle-controlled phase 3 clinical trials NEAR-1 (NCT04599933) and NEAR-2 (NCT04599972) involving over 600 patients.
Both trials met their primary and key secondary endpoints on Day 8, achieving a statistically significant 3-line or more gain in distance-corrected near visual acuity and no loss of 1-line or more in distance visual acuity.
Kedar expands on the clinical data below.
Any adverse events reported?
The most common treatment-related adverse events (AEs) included headache (6.8%) and pain at the instillation site (5.8%).
Of the QLOSI-treated patients, only 1.3% reported moderate treatment-related AEs; all others were mild, according to Orasis.
Significance?
With this approval, QLOSI is now the second prescription drop (soon to be) available in the U.S. indicated for the treatment of presbyopia.
Lastly … when will it be available?
Per Orasis, the medication is expected to be commercially available in the U.S. in the first half of 2024.