U.S. FDA approves expanded indication for Ryzumvi to treat presbyopia; clinical trials meet 27.2% efficacy threshold.
Jetema introduces domestically developed product; Kwangdong Pharmaceutical and Optus Pharmaceutical also pursue domestic commercialization.
The options for managing presbyopia with eye drops are expanding. As approvals for presbyopia-treating eye drops continue in the United States, South Korean companies are also pushing for product introductions and regulatory clearances. However, these treatments do not reverse the aging of the eye. They are designed to improve the ability to read close-up text, and patients must carefully distinguish between actual efficacy and potential side effects.
On the 16th of last month, the U.S. Food and Drug Administration (FDA) expanded the scope of the 0.75% phentolamine ophthalmic solution 'RYZUMVI' to include the treatment of adult presbyopia. Previously, the product was approved for reducing pupil size, often used during ophthalmic examinations. Under U.S. labeling, the dosage for presbyopia is one drop in each eye every night.
Ryzumvi works by blocking alpha-adrenergic receptors in the iris dilator muscle to reduce pupil size. Its mechanism differs from some existing presbyopia drops in that it does not act on the ciliary muscle involved in focusing. The approach focuses on improving near vision by narrowing the pupil rather than restoring the eye's natural accommodation function.
In the Phase 3 'VEGA-3' clinical trial, after seven days of administration, 27.2% of the treatment group achieved a gain of three or more lines on a near-vision chart 12 hours after the final dose, with less than one line of loss in distance vision, compared to 11.5% in the control group. This result was measured under bright lighting with distance vision corrected by glasses. In another Phase 3 trial, 'VEGA-2', the rates meeting the same criteria were 22.6% and 11.0%, respectively.
These figures do not represent a cure rate or the percentage of patients who stopped using reading glasses. It is a measure of the proportion of patients who met specific vision improvement criteria at a given time, meaning not every patient can replace reading glasses with eye drops alone.
[Photo: An AI-generated image symbolizing the discomfort of near-vision impairment due to presbyopia.]
In South Korea, Jetema is pursuing the approval and sale of a presbyopia eye drop developed by a local pharmaceutical company. CEO Nam Jung-sun explained in a media interview last July that the company is adopting a structure to introduce a domestic product that improves upon the efficacy of global pharmaceutical offerings. On the 16th of the same month, Jetema announced its application for domestic manufacturing and sales approval for 'Jetema Pilocarpine Ophthalmic Solution 1.2%', a disposable prescription drug with pilocarpine hydrochloride as its active ingredient.
According to Jetema, the introduced product has completed domestic Phase 3 clinical trials and provides near-vision improvement for approximately six hours after application. The company stated that the active ingredient content was designed with the characteristics of the Korean iris in mind. However, as this is the company's claim, it cannot be directly compared to the efficacy of Ryzumvi, which was tested under different clinical conditions.
Jetema plans to utilize its existing direct sales network and Contract Sales Organizations (CSOs) specializing in ophthalmology once approval is granted. This marks an attempt to expand its business from aesthetics—centered on dermatology and plastic surgery—into ophthalmic prescription drugs. For the completion of clinical trials and approval applications to lead to actual commercialization, regulatory review and the securing of sales channels must follow.
Kwangdong Pharmaceutical and Optus Pharmaceutical are also pursuing the domestic introduction of products developed overseas. Kwangdong Pharmaceutical has secured domestic rights for the carbachol/brimonidine combination eye drop 'YUVEZZI' and has applied for product approval. Optus Pharmaceutical also announced its application for domestic approval last month for the pilocarpine-based eye drop 'QLOSI'. It is important to distinguish between the application for approval, final authorization, and actual market launch.
Side effects must also be considered. In Ryzumvi's presbyopia clinical trials, conjunctival hyperemia was reported in 21% of subjects, and eye irritation in 16%. Use is not recommended for patients with active ocular inflammation. The clinical trial subjects were aged 40 to 64, and those over 65 were not included. However, the U.S. approval for presbyopia treatment covers adults and is not strictly limited to those under 64. These clinical results and precautions should not be applied indiscriminately to other presbyopia eye drops.
Presbyopia eye drops can be an option for improving near vision in some patients. However, the term 'presbyopia treatment' does not mean it reverses eye aging or allows everyone to stop using reading glasses. During the domestic commercialization process, it is crucial to explain both the expected benefits and limitations, and to distinguish between the degree of improvement, duration of effect, and side effects of each product.
