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Ponte Vedra, FL, April 7, 2025 – Orasis Pharmaceuticals, an ophthalmic pharmaceutical company delivering solutions to reshape vision possibilities, today announced that Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, a novel, corrective prescription eye drop for the treatment of presbyopia, or age-related blurry near vision, in adults is now available to prescribe in the U.S.
Qlosi’s proprietary EyeQ Formulation™ maximizes efficacy while minimizing side effects by balancing the lowest approved concentration of pilocarpine at a near neutral pH for optimal bioavailability, is preservative-free in single-use vials, and includes lubricants (HA & HPMC) for comfort. Patients have the flexibility of using one drop of Qlosi in each eye for improved near vision for a specific occasion or activity, and up to two drops per day for an extended effect, lasting up to eight hours.
“We are proud to deliver Qlosi, a solution that ushers in a new era in near vision correction and aims to empower patients, providing Qlosi Clear Moments through improved near vision,” said Elad Kedar, Chief Executive Officer 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.”
Presbyopia, the loss of ability to focus on near objects as a result of the natural aging process, affects more than 128 million people in the U.S. and cannot be prevented or reversed.1,2 Qlosi was shown to improve near vision by pupil modulation, resulting in a “pinhole effect” and an increase in the depth of field, increasing the ability to focus on near objects with no mean impact on distance vision. The FDA approval of Qlosi was based on results from the Phase 3 NEAR-1 and NEAR-2 clinical trials which met their primary and key secondary endpoints on Day 8.
“Qlosi is a breakthrough option for presbyopia patients, delivering functional near vision (20/40 near vision or better) in most patients, which is equivalent to a seven-point font such as the text that appears on a driver’s license. In addition, the combination of Qlosi’s efficacy and safety profile and EyeQ Formulation makes it a compelling solution for many of my early to moderate presbyopic patients who are looking for convenient options without compromising their activities,” said Paul Karpecki, OD, FAAO, Director of Cornea and External Disease for the Kentucky Eye Institute, and Associate Professor, University of Pikeville, Kentucky College of Optometry.
Patients can fill prescriptions via two pharmacy partners, BlinkRx and Medvantx, and receive free home delivery. Qlosi is available in single-use vials that can be taken on-the-go.
“The launch of Qlosi represents a potentially transformative moment, not just for many patients seeking alternatives to readers, but also for eye care professionals looking to expand their practice by incorporating innovative solutions to manage presbyopia,” said Jackie Garlich, OD, FAAO, Owner, Envision Optometry in Boston, Massachusetts. “I’m excited to integrate Qlosi into my practice and offer my patients a novel, discreet way to approach near vision care.”
For more information about Qlosi and Full Prescribing Information, visit www.QlosiECP.com, which includes resources for patients and eye care professionals on how to use Qlosi and the Qlosi Clear Start Kit that patients will receive with their first prescription. The Clear Start Kit will provide guidance on starting Qlosi twice a day for the first week and how to use it for occasional days or long-term to help patients achieve their best near vision.
About the Qlosi Clinical Development Program
The FDA approval of Qlosi was based on results from two pivotal, Phase 3 clinical trials, NEAR-1 and NEAR-2, which evaluated the efficacy, safety and tolerability of Qlosi in more than 600 adult patients with presbyopia. 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. In clinical trials, presbyopia patients achieved their best results when taking Qlosi consecutively over two weeks. All adverse events reported were in the single digits, with headache (6.8%) and instillation site pain (5.8%) being the most commonly reported treatment-related adverse events (TRAEs). The percentage of Qlosi participants who experienced a mild ocular TRAE was 96.1% while the percentage of Qlosi participants who experienced a moderate ocular TRAE was 3.9%.3
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.1 There are almost two billion people globally and more than 128 million people in the U.S. living with presbyopia.2,3 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 presbyopia patients. Presbyopia can be diagnosed during an eye exam conducted by an eye care professional.5
About Qlosi
Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4% is a novel corrective eye drop indicated for the treatment of presbyopia in adults. Qlosi’s EyeQ Formulation™ delivers the lowest effective concentration of pilocarpine approved in a preservative-free eye drop, with a near-neutral pH and dual lubricating agents to provide enhanced safety and patient comfort without compromising on efficacy.3,6,7,8 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 without negatively impacting distance vision. The most commonly reported treatment-related adverse events (TRAEs) were headache and instillation site pain, at rates of 6.8% and 5.8%, respectively.
About Orasis Pharmaceuticals
Orasis Pharmaceuticals is an ophthalmic pharmaceutical company delivering solutions to reshape vision possibilities. Orasis has developed Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, a novel, corrective prescription eye drop for the treatment of presbyopia, or age-related blurry near vision, in adults. Orasis is led by a collaborative team of industry executives and eye care professionals working to transform the standard of care for near vision correction. Orasis is funded by a diverse group of sophisticated and experienced life science and healthcare investors. Orasis has offices in the United States and Israel.
References
Qlosi’s proprietary EyeQ Formulation™ maximizes efficacy while minimizing side effects by balancing the lowest approved concentration of pilocarpine at a near neutral pH for optimal bioavailability, is preservative-free in single-use vials, and includes lubricants (HA & HPMC) for comfort. Patients have the flexibility of using one drop of Qlosi in each eye for improved near vision for a specific occasion or activity, and up to two drops per day for an extended effect, lasting up to eight hours.
“We are proud to deliver Qlosi, a solution that ushers in a new era in near vision correction and aims to empower patients, providing Qlosi Clear Moments through improved near vision,” said Elad Kedar, Chief Executive Officer 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.”
Presbyopia, the loss of ability to focus on near objects as a result of the natural aging process, affects more than 128 million people in the U.S. and cannot be prevented or reversed.1,2 Qlosi was shown to improve near vision by pupil modulation, resulting in a “pinhole effect” and an increase in the depth of field, increasing the ability to focus on near objects with no mean impact on distance vision. The FDA approval of Qlosi was based on results from the Phase 3 NEAR-1 and NEAR-2 clinical trials which met their primary and key secondary endpoints on Day 8.
“Qlosi is a breakthrough option for presbyopia patients, delivering functional near vision (20/40 near vision or better) in most patients, which is equivalent to a seven-point font such as the text that appears on a driver’s license. In addition, the combination of Qlosi’s efficacy and safety profile and EyeQ Formulation makes it a compelling solution for many of my early to moderate presbyopic patients who are looking for convenient options without compromising their activities,” said Paul Karpecki, OD, FAAO, Director of Cornea and External Disease for the Kentucky Eye Institute, and Associate Professor, University of Pikeville, Kentucky College of Optometry.
Patients can fill prescriptions via two pharmacy partners, BlinkRx and Medvantx, and receive free home delivery. Qlosi is available in single-use vials that can be taken on-the-go.
“The launch of Qlosi represents a potentially transformative moment, not just for many patients seeking alternatives to readers, but also for eye care professionals looking to expand their practice by incorporating innovative solutions to manage presbyopia,” said Jackie Garlich, OD, FAAO, Owner, Envision Optometry in Boston, Massachusetts. “I’m excited to integrate Qlosi into my practice and offer my patients a novel, discreet way to approach near vision care.”
For more information about Qlosi and Full Prescribing Information, visit www.QlosiECP.com, which includes resources for patients and eye care professionals on how to use Qlosi and the Qlosi Clear Start Kit that patients will receive with their first prescription. The Clear Start Kit will provide guidance on starting Qlosi twice a day for the first week and how to use it for occasional days or long-term to help patients achieve their best near vision.
About the Qlosi Clinical Development Program
The FDA approval of Qlosi was based on results from two pivotal, Phase 3 clinical trials, NEAR-1 and NEAR-2, which evaluated the efficacy, safety and tolerability of Qlosi in more than 600 adult patients with presbyopia. 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. In clinical trials, presbyopia patients achieved their best results when taking Qlosi consecutively over two weeks. All adverse events reported were in the single digits, with headache (6.8%) and instillation site pain (5.8%) being the most commonly reported treatment-related adverse events (TRAEs). The percentage of Qlosi participants who experienced a mild ocular TRAE was 96.1% while the percentage of Qlosi participants who experienced a moderate ocular TRAE was 3.9%.3
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.1 There are almost two billion people globally and more than 128 million people in the U.S. living with presbyopia.2,3 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 presbyopia patients. Presbyopia can be diagnosed during an eye exam conducted by an eye care professional.5
About Qlosi
Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4% is a novel corrective eye drop indicated for the treatment of presbyopia in adults. Qlosi’s EyeQ Formulation™ delivers the lowest effective concentration of pilocarpine approved in a preservative-free eye drop, with a near-neutral pH and dual lubricating agents to provide enhanced safety and patient comfort without compromising on efficacy.3,6,7,8 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 without negatively impacting distance vision. The most commonly reported treatment-related adverse events (TRAEs) were headache and instillation site pain, at rates of 6.8% and 5.8%, respectively.
About Orasis Pharmaceuticals
Orasis Pharmaceuticals is an ophthalmic pharmaceutical company delivering solutions to reshape vision possibilities. Orasis has developed Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, a novel, corrective prescription eye drop for the treatment of presbyopia, or age-related blurry near vision, in adults. Orasis is led by a collaborative team of industry executives and eye care professionals working to transform the standard of care for near vision correction. Orasis is funded by a diverse group of sophisticated and experienced life science and healthcare investors. Orasis has offices in the United States and Israel.
References
- Holden BA, et al. Global Vision Impairment Due to Uncorrected Presbyopia. Arch Ophthalmol. 2008;126(12):1731-1739. https://jamanetwork.com/journals/jamaophthalmology/fullarticle/420914
- U.S. Census Bureau. United States Census – Populations and People. Accessed April 7, 2025. https://data.census.gov/profile/United_States?g=010XX00US.
- Holland E, Karpecki P, Fingeret M, Smits G, Ignacio T, Lindstrom R. (n.d.-a). Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials. Clinical Therapeutics. https://www.clinicaltherapeutics.com/article/S0149-2918(23)00478-2/fulltext
- Fricke TR, et al. Global Prevalence of Presbyopia and Vision Impairment from Uncorrected Presbyopia. American Academy of Ophthalmology. 2018;125(10):1492-1499. https://www.aaojournal.org/article/S0161-6420(17)33797-1/fulltext.
- WebMD. Presbyopia: Symptoms, diagnosis, and treatment. Accessed April 7, 2025. https://www.webmd.com/eye-health/eye-health-presbyopia-eyes.
- Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%. Prescribing Information. Orasis Pharmaceuticals; 2023.
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed April 7, 2025. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.
- Holland E, Karpecki P, Fingeret M, et al. Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials. Clinical Therapeutics. 2024;46(2):104-113.
