Orasis Pharmaceuticals Launches Qlosi Eye Drops for Presbyopia in the U.S.

Orasis Pharmaceuticals has announced the U.S. availability of its novel corrective eye drop, Qlosi (pilocarpine hydrochloride ophthalmic solution 0.4%), a new treatment option for adults with presbyopia.

Clinical Overview of Qlosi for Presbyopia Management

Qlosi is a prescription topical ophthalmic solution formulated to improve near vision in adults with presbyopia. It is:

       • Preservative-free

       • Packaged in single-use vials

       • Formulated with dual lubricants—hyaluronic acid and hydroxypropyl methylcellulose—to enhance patient comfort

Patients can apply:

       • One drop per eye for occasion-based use

       • Or up to two drops daily for effects lasting up to 8 hours

Prescriptions for Qlosi can be conveniently filled through BlinkRx or Medvantx, with free home delivery available.

EyeQ Formulation and Its Role in Qlosi's Pharmacologic Profile

The proprietary EyeQ Formulation is designed to balance efficacy and safety. It features:

       • The lowest FDA-approved concentration of pilocarpine (0.4%)

       • A near-neutral pH to closely match natural tears, supporting optimal bioavailability and minimized side effects

“We are proud to deliver [pilocarpine hydrochloride ophthalmic solution 0.4%], a solution that ushers in a new era in near vision correction and aims to empower patients,” said Elad Kedar, CEO of Orasis Pharmaceuticals. “Our goal has always been to improve near vision for the millions of people struggling with presbyopia, give them a break from readers, and provide eye care professionals with an additional option to optimize care for their patients.”

Expert Insight on Pharmacologic Innovation

Speaking to Ophthalmology Times, Dr. Richard L. Lindstrom, founder of Minnesota Eye Consultants and adjunct professor emeritus at the University of Minnesota Department of Ophthalmology, emphasized the critical role of formulation in presbyopia therapies.

“As we’ve seen with other ophthalmic treatments, even small adjustments in formulation can have a significant impact on efficacy, safety, and tolerability,” Lindstrom noted.
“Products like Qlosi, with its EyeQ Formulation, which minimizes pilocarpine concentrations and closely matches the pH of natural tears, offers a compelling and patient-friendly treatment option.”

Backed by Pivotal Phase 3 Trials

Qlosi received FDA approval in October 2023, based on the results from two Phase 3 clinical trials:

       • NEAR-1 (NCT04599933)

       • NEAR-2 (NCT04599972)

These trials included over 600 adult participants with presbyopia. Key outcomes:

       • Statistically significant 3-line or greater improvement in distance-corrected near visual acuity by Day 8

       • No 1-line or greater loss in distance visual acuity

       • Optimal results achieved with 2 weeks of consecutive use

Treatment-related adverse events were minimal and occurred in single-digit percentages, with:

       • Headache reported in 6.8% of participants

       • Instillation site pain in 5.8%