Orasis Pharmaceuticals Announces Licensing Agreement with Optus Pharmaceuticals for Commercialization of Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4% in Korea

Exclusive Agreement Includes $18 Million in Milestone Payments to Orasis, Together with a Double-Digit Royalty on Sales in the Korean Market

Additional Capital Follows Orasis' Recent $78 Million Financing to Support Commercial Launch of Qlosi in the United States

PONTE VEDRA, Fla., Oct. 16, 2024 /PRNewswire/ -- Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, today announced the signing of an exclusive licensing agreement with Optus Pharmaceuticals, a Korean-based pharmaceutical company specializing in total eye care solutions. Under the agreement, Orasis grants Optus Pharmaceuticals the rights to commercialize, import and sell Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%, a novel corrective eye drop for the treatment of presbyopia in adults, in Korea.

"Our licensing agreement with Optus Pharmaceuticals marks an important step in our goal of offering patients around the world a safe, effective and innovative solution to manage their presbyopia," said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. "Building on the momentum of our recent Series D financing to support our first market launch in the U.S., this partnership represents our commitment to bring Qlosi to more patients globally and define what's next in vision care."

Additional terms include an upfront payment and payments for key milestones, totaling $18 million, in addition to double-digit royalties on sales in the Korean market. Optus Pharmaceuticals plans to be the first to launch a new presbyopia treatment drug in the Korean market, and plans to launch Qlosi in Korea by 2026, after receiving domestic regulatory approval and sales approval.

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

About Orasis Pharmaceuticals
Orasis Pharmaceuticals developed Qlosi, a corrective eye drop for the treatment of presbyopia in adults. 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. Orasis has offices in the United States and Israel. For more information, visit www.orasis-pharma.com and follow us on LinkedIn and X.

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 formulation includes the lowest effective concentration of pilocarpine approved,^1,2 together with a multi-faceted vehicle, and does not contain an anti-microbial preservative. Qlosi was designed to achieve a balance between efficacy, safety, and comfort.³ 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.

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.

Media Contact:
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References:

¹ Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4%. Prescribing Information. Orasis Pharmaceuticals; 2023.
² U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed October 15, 2024. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm.
³ 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.

SOURCE Orasis Pharmaceuticals