OSAKA, Japan and BRIDGEWATER, N.J., July 28, 2020 (GLOBE NEWSWIRE) -- Santen Pharmaceutical Co., Ltd (hereinafter, Santen) and RVL Pharmaceuticals, Inc., a subsidiary of Osmotica Pharmaceuticals plc (NASDAQ:OSMT) (hereinafter, Osmotica), announced today an exclusive license agreement covering the development, registration, and commercialization rights in Japan, China, and other Asian countries as well as EMEA countries to RVL-1201, oxymetazoline hydrochloride ophthalmic solution 0.1%, which is the first and only ophthalmic formulation approved by the U.S. Food and Drug Administration (FDA) for the treatment of acquired blepharoptosis or ptosis in adults. Santen will be responsible for further development of RVL-1201 and regulatory approvals as well as commercialization in its licensed territories under the agreement.
RVL-1201 is a novel, once-daily ophthalmic formulation of oxymetazoline, a direct-acting alpha adrenergic receptor agonist, which when administered to the eye, is believed to selectively target Müller’s muscle and elevate the upper eyelid. RVL-1201, was approved on July 8, 2020 under the brand name UPNEEQ™ in the United States.
Acquired blepharoptosis, also known as ptosis or droopy eyelid, is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid. It can lead to loss of visual field and cosmetic concerns for patients. While precise prevalence of the condition is unknown, tens of millions of adults are believed to suffer from ptosis globally¹⋅². The companies believe that there are no approved pharmacologic treatments for acquired ptosis anywhere outside the United States.
Shigeo Taniuchi, Santen President and CEO said, “Our mission is to try our hand at resolving eye health-related social challenges that patients worldwide are facing and, in turn, contributing to improving eye health. As a specialized ophthalmic company, we are very pleased to be entering into this license agreement with Osmotica. Ptosis is said to cause conditions such as tight shoulders, cephalalgia, and asthenopia, and is a disease that lowers the Quality of Life (QoL). To better the QoL of patients across the world through eye health and wellness, thus to achieve our WORLD VISION, “Happiness with VISION” that we have set in the new long-term vision, Santen proactively engages in collaborative and open innovation endeavors with various external institutions. We hope that our agreement with Osmotica enables us to serve to people’s eyecare.”
“We are delighted to have formed a partnership with Santen, a leading multi-national ophthalmology company, to develop and commercialize RVL-1201 across Japan, China, and other Asian countries as well as EMEA. RVL-1201 is the first-in-class, non-invasive therapy for ptosis in the US, and if successfully approved in other countries, it will similarly address a significant unmet need for patients and providers across the world,” stated Brian Markison, Osmotica’s Chief Executive Officer. “With its preeminent position in eye care and its established sales organization, Santen is an ideal partner to address the large treatment gap in ptosis and ensure that patients across its broad global footprint will have access to this therapeutic. This is a meaningful advancement and value-driver for our organization,” concluded Markison.
Under the terms of the licensing agreement, Osmotica will receive up to $89 million in upfront and milestone payments, not including future royalties on sales in Santen’s territories. Osmotica will receive an upfront cash payment of $25 million and up to an additional $64 million in cash milestone payments based on regulatory and sales achievements in Santen’s territories. Osmotica is also entitled to royalty payments on sales of RVL-1201 in Japan, China, and other Asian countries as well as EMEA.
¹ Source: A Community Survey of Ptosis of the Eyelid and Pupil Size of Elderly People. G. V. SRIDHARAN, R. C. TALLIS, B. LEATHERBARROW, W. M. FORMAN.
² Source: Eye The Scientific Journal of The Royal College of Ophthalmologists. 2017 Jun; 31(6): 940–946. Prevalence and associated factors of blepharoptosis in Korean adult population: The Korea National Health and Nutrition Examination Survey 2008–2011 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5518839/