Orasis Pharmaceuticals Announces FDA Approval of QLOSItm (pilocarpine hydrochloride ophthalmic solution) 0.4% for the Treatment of Presbyopia

• QLOSItm is a preservative-free, low-dose eye drop for presbyopia, which consistently demonstrated efficacy, safety, and tolerability in two pivotal Phase 3 trials
• Affecting more than 128 million people in the U.S., presbyopia is the loss of ability to focus on near objects as a result of the natural aging process

PONTE VEDRA, Fla., Oct. 18, 2023 /PRNewswire/ -- Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced that the U.S. Food and Drug Administration (FDA) has approved QLOSItm (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. QLOSI is expected to be commercially available in the U.S. in the first half of 2024.

"The FDA approval of QLOSI marks a tremendous milestone for Orasis as we continue our mission to provide a flexible treatment option for the millions of people in the U.S. living with presbyopia, or blurry near vision," said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. "I am grateful to the Orasis team, our strategic partners, clinical investigators, and patients who participated in our clinical trials, all of whom made this achievement possible."

QLOSI (pronounced CLOH-see) is a prescription eye drop that can be used daily, or as needed, up to twice per day. QLOSI demonstrated efficacy 20 minutes after administration and can last up to 8 hours, as measured on day 15, to improve near vision without impacting distance or night vision. QLOSI is a preservative-free formulation of pilocarpine, an established eye care therapeutic, designed to achieve an optimal balance between efficacy, safety, and comfort.

"Patients experiencing age-related, blurry near vision are in need of flexible treatment options to manage their presbyopia in ways that work for them with fewer tradeoffs," said Paul Karpecki, O.D., FAAO, Director, Cornea and External Disease, Kentucky Eye Institute, and Associate Professor, University of Pikeville, Kentucky College of Optometry. "In clinical trials, QLOSI demonstrated the optimal balance of efficacy, safety, and tolerability, and the FDA approval marks an exciting next step in being able to provide a new treatment for patients looking for a break from reading glasses or contact lenses."

The FDA approval is based on results from the Phase 3 NEAR-1 and NEAR-2 clinical trials, involving more than 600 patients, which evaluated the efficacy and safety of QLOSI. Both trials met their primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity (DCNVA), and no loss of 1-line or more in distance visual acuity. The most common treatment-related adverse events of headache and instillation site pain occurred in only 6.8% and 5.8% of participants, respectively. Of all QLOSI participants, only 1.3% reported moderate treatment-related adverse events. All other adverse events were mild.

"Providers are eager to improve outcomes for their presbyopia patients, who often struggle with the inflexibility of current treatment options," said Sheri Rowen, M.D., FACS, FWCRS, PCEO, Medical Director NVision Eye Centers, Newport Beach, CA. "Patients will be delighted to have the option to customize their use of low-dose pilocarpine for their personal visual needs. Based on the statistically significant efficacy and tolerability demonstrated in the two pivotal clinical trials with such a minimum effective dose, QLOSI's results reinforce the important role of formulation in reimagining a new approach to treating these patients."

For more information about QLOSI and Full Prescribing Information, visit www.Qlosi.com.

Additional Commentary 

"We are proud to receive FDA approval of QLOSI to provide patients and eye care professionals, who are looking to reduce dependence on readers, a new option within this growing category," said Paul Smith, President and Chief Operating Officer at Orasis Pharmaceuticals. "This milestone is just the beginning as we start scaling the organization to support the launch of QLOSI in 1H 2024."

"Optometrists, who deliver the majority of eye care exams, will play a critical role in the continued diagnosis and treatment plan for presbyopes," said Gina Wesley O.D., MS, FAAO, Owner of Complete Eye Care of Medina. "For new and existing patients that are looking for options beyond readers and contact lenses, I'm looking forward to being able to provide QLOSI as an additional option for patients to manage their presbyopia."

"Each presbyopia patient has different visual demands, yet all are impacted in the ability to perform day-to-day functions," said Richard Lindstrom, M.D., Founder and Attending Surgeon Emeritus, Minnesota Eye Consultants. "It's very exciting to see a novel, new treatment category emerging for this challenging patient population which will give eye care professionals more options throughout the presbyopic journey."

About QLOSI
QLOSItm (pilocarpine hydrochloride ophthalmic solution) 0.4% is a novel corrective eye drop indicated for the treatment of presbyopia in adults. QLOSI is a preservative-free formulation of low-dose pilocarpine and multi-faceted vehicle designed to achieve an optimal balance between efficacy, safety, and comfort. QLOSI improves near visual acuity by pupil modulation, resulting in a "pinhole effect" and an increase in the depth of field, thus increasing the ability to focus on near objects.

About Presbyopia
Presbyopia is the loss of ability to focus on near objects as a result of the natural aging process. It occurs mostly after the age of 40 when the crystalline lens of the eye gradually stiffens and loses flexibility. There are almost two billion people globally and more than 128 million people in the U.S. living with presbyopia. People with presbyopia experience blurred vision when performing daily tasks that require near visual acuity, such as reading a book, a restaurant menu, or messages on a smartphone. Presbyopia cannot be prevented or reversed, and it continues to progress gradually. Many existing treatment options can be either cumbersome or invasive, presenting a significant unmet need for quality-of-life improvement for people with presbyopia.

About Orasis Pharmaceuticals
Orasis Pharmaceuticals developed QLOSI, a corrective eye drop for the treatment of presbyopia. Orasis is led by a collaborative team of industry executives and eye care professionals with a broad range of experiences in research, development, and commercialization of pharmaceutical drugs, as well as finance and business development. Orasis is funded by a diverse group of sophisticated and experienced life science and healthcare investors including the ophthalmology focused venture capital fund Visionary Ventures, Sequoia Capital, SBI (Japan) Innovation Fund, Bluestem Capital, LifeSci Venture Partners, Maverick Ventures Israel, and other private investors. Orasis has offices in the U.S. and Israel. For more information, visit www.orasis-pharma.com and connect with us on LinkedIn.

QLOSI Indication and Important Safety Information

Indication
QLOSItm (pilocarpine hydrochloride ophthalmic solution) 0.4%, for topical ophthalmic use is a cholinergic receptor agonist indicated for the treatment of presbyopia in adults.

Important Safety Information

CONTRAINDICATIONS

• Hypersensitivity

WARNINGS AND PRECAUTIONS

• Advise patients to not drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous occupations in poor illumination.
• Rare cases of retinal detachment have been reported with miotics. Examination of the retina is advised in all patients prior to initiation of therapy. Advise patients to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss.
• QLOSI is not recommended to be used when iritis is present.
• QLOSI should not be administered while wearing contact lenses. Remove lenses prior to the installation of QLOSI and wait 10 minutes before reinsertion.
• Avoid touching the tip of the vial to the eye or any other surface.

ADVERSE REACTIONS

• The most common adverse reactions (5% to 8%) are instillation site pain and headaches.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Media Contact:
Amy Phillips
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412-327-9499

SOURCE Orasis Pharmaceuticals