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Johnson & Johnson Invests in QLOSI™

(pilocarpine hydrochloride ophthalmic solution) 0.4%

A Novel Prescription Eye Drop for the Treatment of Presbyopia in Adults

The investment demonstrates J&J’s commitment to making vision possible for the high unmet patient needs of presbyopia in adults.

When Johnson & Johnson learned of the groundbreaking work from Orasis Pharmaceuticals, an emerging ophthalmic pharmaceuticals company, they knew it has the potential to be an excellent complement to their existing expertise in solutions to treat presbyopia, or loss of near vision, in adults. On September 19, 2024, J&J closed a transaction as the co-lead investor of Series D funding in Orasis Pharmaceuticals, creators of the QLOSI™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, prescription eye drops, for presbyopes seeking a break from readers.

Headquartered in Ponte Vedra, Florida, Orasis Pharmaceutical’s mission is to reshape vision possibilities and provide a flexible treatment option for the millions of people in the U.S. living with presbyopia. For J&J, it’s an aligned addition to Vision Made Possible™, a global effort to raise awareness and ignite conversation about the importance of eye health across all ages and stages of vision.

The QLOSI™ Eye Drop

QLOSI™ (pronounced CLOH-see) is a prescription eye drop that is designed to improve 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. See prescribing information for more details.

Orasis received FDA approval for QLOSI™ in October 20231. Elad Kedar, CEO of Orasis Pharmaceuticals said, “It was critical for us to identify the minimum effective dose for a presbyopic solution which would truly balance efficacy, safety, and comfort. QLOSI was designed around the needs of the patients.”

An Underserved Market

Presbyopia is the gradual loss of the eye’s ability to focus on near objects, which begins to affect most adults sometime after the age of 40.2 Approximately 128 million people in the US and 1.9 million people worldwide are affected by presbyopia, and that number is expected to reach 2.1 billion people globally by 2030.3,4

Patients classified as “emerging presbyope” and “moderate presbyope”, with near vision needs of 0 to +1D and +1.25 to +2D, respectively, are underserved in the US presbyopia segment and represent nearly 60 million people. Currently, this population relies primarily on readers, glasses, or contact lenses as their primary form of vision correction. However, nearly 64% of these adults report being unhappy with glasses.

“At Johnson & Johnson we are deeply focused on improving patient outcomes and innovating where high science meets high unmet need. Our investment in Orasis Pharmaceuticals and QLOSI, is an outstanding opportunity to address an underserved segment of the presbyopia market with a unique product that was designed with the patient at the forefront,” said Peter Menziuso, Company Group Chairman, Vision, J&J.

Investing in the Future of Eye Health

J&J is excited to invest in this innovation which has the potential to complement its existing expertise in solutions to treat presbyopia. It is a partnership that will have the ability to transform the patient experience and create new standards of care in ophthalmology.

The Vision business unit at J&J, together with JJDC, the strategic venture capital arm of Johnson & Johnson, brought together other equity investors to close this deal. Through this investment, J&J furthers its commitment to innovation and improving vision care for millions of people worldwide. It’s just one more way J&J is delivering on their promise of Vision Made Possible™.

More details can be read here.

Qlosi Indication and Important Safety Information

Indication

Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, for topical ophthalmic use is a cholinergic 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.

References:

  1. https://www.prnewswire.com/news-releases/orasis-pharmaceuticals-announces-fda-approval-of-qlosi-pilocarpine-hydrochloride-ophthalmic-solution-0-4-for-the-treatment-of-presbyopia-301959581.html
  2. American Academy of Ophthalmology. What is Presbyopia. Published May 2024. https://www.aao.org/eye-health/diseases/what-is-presbyopia
  3. Holden, B. A., Fricke, T. R., Ho, S. M., Wong, R., Schlenther, G., Cronje, S., Burnett, A., Papas, E., Naidoo, K. S., & Frick, K. D. (2008, December 8).Global Vision Impairment Due to Uncorrected Presbyopia. Journal of Americal Medical Association – Ophthalmology.
    https://jamanetwork.com/journals/jamaophthalmology/fullarticle/420914
  4. Presbyopia – A Review of Current Treatment Options and Emerging Therapies. Clinical Ophthalmology. Published May 2021;