Orasis Pharmaceuticals recently announced the beginning of a phase 2b U.S. clinical trial to evaluate CSF-1, its presbyopia-correcting eye drop.
Primary Care Optometry News spoke with Orasis CEO Elad Kedar about how the drop works and the potential impact on patient care.
PCON: How do the eye drops work? How did the technology/idea come about?
Kedar: The treatment effect of CSF-1 is to overcome the loss of near vision in people with presbyopia. When administered, CSF-1 creates a “pinhole effect” in the eye through pupil modulation, thus increasing the depth of field and the ability to focus on near objects. The eye drop contains a proprietary combination of existing and well-studied ingredients with the potential to restore near vision in people with presbyopia.
We know there are more than 1.8 billion people worldwide living with presbyopia, and 2.5 million people are diagnosed each year in the U.S. alone. However, there is no pharmaceutical solution currently available for these individuals. We are developing CSF-1 as a meaningful alternative to reading glasses to potentially improve the quality of life for people living with this condition.
PCON: What were phase 1 or 2a side effects from treatment?
Kedar: CSF-1 has demonstrated a great safety profile in clinical trials to date. The eye drop was reported to have minimal side effects; adverse events that were reported in clinical trials to date were mild, temporary (the vast majority lasted only a few seconds or a few minutes) and are typical for most eye drops.
PCON: What type of impact do you expect this to have for patients and for optometrists?
Kedar: We designed CSF-1 to be a convenient and on-demand solution for people living with presbyopia. We hope CSF-1 can offer a meaningful and impactful alternative to alleviate the burden of reading glasses for people affected by presbyopia, as well as their optometrists and ophthalmologists.
PCON: How is this different than other products/treatments on the market?
Kedar: All existing treatment options for presbyopia are either cumbersome or invasive, presenting a significant unmet need for quality of life improvement for people with presbyopia.
The standard of care is the use of reading glasses, which can be easily misplaced, lost or broken. They need to be replaced frequently as presbyopia progresses and near vision continues to worsen. Reading glasses inhibit distance vision and, therefore, need to be removed frequently when an individual switches between looking at near objects and distance objects. Reading glasses also carry the stigma of aging. Other treatment options such as contact lenses and surgery are inconvenient, uncomfortable and invasive.
CSF-1 is designed to be convenient, on-demand and reversible, with the potential to improve the quality of life for people with presbyopia.
PCON: Does Orasis have an estimated timeframe for drug approval?
Kedar: Currently we are fully focused on executing on our phase 2b clinical study, which started enrollment in February. We will share the results from the trial in the near future, as well as the next steps in CSF-1’s clinical development. We look forward to advancing CSF-1 in the clinic and eventually bringing it to people living with presbyopia worldwide. – interviewed by Abigail Sutton
Disclosure: Kedar is CEO of Orasis Pharmaceuticals.