RVL Pharmaceuticals Partners with Santen for Eye Treatment Approval in Japan

RVL Pharmaceuticals, Inc., along with its affiliates, has exciting news regarding its partnership with Santen Pharmaceutical Co., Ltd., a leading company in the field of ophthalmology. The two entities have successfully obtained manufacturing and marketing approval in Japan for UPNEEQ® Mini Ophthalmic Solution 0.1%. This product is a breakthrough treatment for acquired blepharoptosis, which refers to the condition of low-lying eyelids, a common issue for many adults.

This significant step not only marks an expansion of access for eye care in Japan but also introduces the first approved non-invasive treatment option for blepharoptosis. Traditionally, treatment options for this condition have been mainly surgical, making UPNEEQ® a pivotal alternative for patients seeking non-surgical solutions. In the U.S., UPNEEQ® stands out as the first and only FDA-approved prescription eye drop designed specifically for acquired blepharoptosis, enjoying strong patient satisfaction and an increasing adoption rate.

Lori Deo, the Chief Executive Officer of RVL Pharmaceuticals, shared her thoughts on this significant milestone: "UPNEEQ® was developed to provide patients with a meaningful, non-invasive alternative to eyelid surgery. Our partnership with Santen allows us to extend this innovation to patients in Japan. Together, we are addressing a significant unmet need and helping advance new standards of care for acquired blepharoptosis."

The approval in Japan was built upon the findings of a Phase 3 clinical trial, which was placebo-controlled, randomized, and double-masked. The study evaluated the efficacy and safety of the once-daily administration of UPNEEQ® in patients suffering from acquired blepharoptosis. Notably, the results showed that the product outperformed the placebo, particularly evidencing a change from baseline in MRD-1 (Marginal Reflex Distance-1—the distance from the center of the pupil to the upper eyelid margin) at two hours post-administration. Furthermore, the improvements were shown to last beyond eight hours, confirming the product's prolonged effect without serious adverse effects or treatment discontinuation due to side effects.

In the context of UPNEEQ® in the United States, it's essential to highlight that the product is a prescription eye drop, initially approved by the FDA in July 2020 for acquired blepharoptosis. It operates by activating the eyelid muscles, effectively lifting the eyelids and delivering a visibly more alert appearance within a few minutes after application.

However, with the benefits, it is crucial to be aware of potential safety information. Low-lying eyelids can be symptoms of various health conditions such as strokes, brain aneurysms, or even myasthenia gravis. Therefore, patients should communicate openly with their doctors if they suffer from any such conditions. UPNEEQ® might also have effects on blood pressure, necessitating caution for those with pre-existing heart issues.

It is worthwhile to note that RVL Pharmaceuticals operates a digitally enabled, vertically integrated commercial platform, extending from product acquisition to order fulfillment. Their comprehensive approach ensures that consumers and healthcare providers engage seamlessly throughout the process. As RVL continues to pioneer with their flagship product UPNEEQ®, they are confident in their ability to provide a non-surgical solution to a common yet significant issue faced by many adults today.

Santen, with a rich history since its establishment in 1890 in Osaka, Japan, focuses exclusively on advancing eye health. By leveraging over 135 years of expertise in research, development, and marketing of medical solutions for eye care, Santen enhances lives globally through better vision. Now, with the launch of UPNEEQ® in Japan, both RVL and Santen are on a joint mission to elevate eye care standards and deliver accessible, effective treatment options to those in need.

For further details about RVL Pharmaceuticals, please visit www.rvlpharma.com.

To learn more about Santen, you can explore their offerings at www.santen.com/en.