Orasis Pharmaceuticals

Orasis Pharmaceuticals, founded in 2015, is an ophthalmic pharmaceutical company concentrated on developing treatments for presbyopia, the age-related loss of ability to focus on near objects. With offices in Israel and the U.S., the company is managed by a team with extensive experience in pharmaceutical development and commercialization. The Chief Executive Officer, Elad Kedar, has a background that includes nearly two decades in executive roles at life science organizations, such as CFO of Eli Lilly South-East Europe and founder of PharmaSwiss Israel.

The company's core product is Qlosi™ (formerly CSF-1), a prescription eye drop approved by the U.S. Food and Drug Administration (FDA) in October 2023 for the treatment of presbyopia. Qlosi™ is a preservative-free formulation of low-dose pilocarpine hydrochloride (0.4%) designed to offer a balance of efficacy, safety, and comfort. The business model centers on the commercialization of Qlosi™, targeting the large population of individuals over 40 affected by presbyopia as an alternative to reading glasses. Revenue will be generated through the sale of this prescription product to patients via eye care professionals, including optometrists and ophthalmologists.

Qlosi™ functions by modulating the pupil to create a "pinhole effect," which increases the depth of field and improves the ability to focus on near objects without adversely affecting distance vision. Clinical trials, including the Phase 3 NEAR-1 and NEAR-2 studies which enrolled over 600 participants, demonstrated that the eye drops provided a statistically significant improvement in near visual acuity for up to eight hours. The studies also highlighted a favorable safety profile, with the most common adverse events being mild headache and instillation site pain, reported by a small percentage of participants. To support the U.S. commercial launch, Orasis secured $78 million in a Series D financing round.

Keywords: ophthalmic pharmaceuticals, presbyopia, Qlosi, pilocarpine, eye drops, near vision correction, FDA approved, pinhole effect, pharmaceutical commercialization, life sciences