Orasis Pharmaceuticals announced the initiation of NEAR-1 and NEAR-2 Phase 3 clinical studies in the U.S., evaluating its novel eye drop candidate designed to improve near vision for people with presbyopia.

“We are excited to move into the final stage of clinical development of our corrective eye drop while preparing for pre-commercialization,” said Elad Kedar, chief executive officer of Orasis. “Presbyopia, the inability to focus on near objects, is a progressive, ubiquitous condition that affects almost two billion people above the age of 40 all around the world. Orasis is committed to making near vision clear again for people who live with this condition. Our proprietary eye drop formulation was designed to achieve the optimal balance between efficacy, safety, and comfort. Promising results from our well powered Phase 2b study, along with the recent Series C funding, have paved a promising path for us to advance our product candidate through Phase 3 development and pre-commercialization efforts. We look forward to providing this novel and non-invasive option for presbyopia to eyecare providers and patients.”

The NEAR-1 and NEAR-2 Phase 3 studies are multi-center, double-masked, parallel-group clinical trials in the U.S. enrolling approximately 600 participants with presbyopia to further evaluate the efficacy and safety of Orasis’ eye drop candidate. For more information about the studies, please visit NEAR-1 and NEAR-2.

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 120 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. All existing treatment options are either cumbersome or invasive, presenting a significant unmet need for quality of life improvement for people with presbyopia.