Santen to acquire InnFocus, developer of glaucoma drainage implant

Santen Pharmaceutical will soon acquire InnFocus, developer of a glaucoma implant device (InnFocus Microshunt), for $225 million, according to a definitive agreement from the two companies.

The device is being developed to lower and sustain IOP for treatment of primary open-angle glaucoma (POAG). International clinical trials have shown the implant is effective when used alone, as well as in conjunction with cataract surgery, according to InnFocus.

Courtesy of InnFocus Inc.

The implant device has also received CE Mark in Europe.

The company is in the process of conducting late-stage clinical studies in the United States, as well as in Europe, in advance of its planned Pre-Market Approval (PMA) application to the FDA in the near future.

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“The InnFocus MicroShunt was developed to be the world’s first minimally invasive stand-alone procedure for mild, moderate, and severe-stage POAG. In addition to reducing IOP, the MicroShunt does not require simultaneous cataract removal, unlike many micro-invasive glaucoma surgery (MIGS) technologies,” said Randy Lindholm, executive chairman of the board of InnFocus. “The InnFocus team is very pleased to be joining Santen and its global effort to address this growing and important segment of the ophthalmic market.”

The companies also noted the acquisition is subject to conditions under the Hart-Scott-Rodino Antitrust Improvements Act of the United States.

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Additional details about the acquisition are planned to be announced on Aug. 2, 2016.

“With this acquisition, Santen will strengthen our glaucoma pipeline and stay at the forefront of innovation in ophthalmology,” said Akira Kurokawa, president and chief executive officer of Santen. “This agreement is in line with our long-term vision to become a specialized pharmaceutical company with a global presence. I am truly excited about the MicroShunt as a new and effective treatment option that should significantly improve patient outcomes.”

More about the device

The implant reduces IOP by draining eye fluid. It is made from SIBS; poly(styrene-block-isobutylene-block-styrene), an innovative, highly biocompatible biomaterial that has been implanted in the body for over 15 years, according to the company. Compared with conventional glaucoma surgery, the device is minimally invasive and anticipated to ease postoperative management.

The acquisition will allow the team at Innfocus to finish clinical trials without needing to worry about raising money, "which is a very distracting and time consuming effort when you are otherwise trying to either build a company, complete the clinical trial, or prepare for the launch," said Russ Trenary, president and chief executive officer of InnFocus. "Now everybody knows that there is enough money behind this technology to get it to the marketplace."

Earlier this year, InnFocus released 3-year results for the device and found that patients' IOP was lowered an average of 55% to 10.7 mm Hg from a pre-surgical, medicated IOP of 23.8 mm Hg. More than 80% of the 22 patients studied achieved IOPs under 14 mm Hg, and 64% of the patients did not require any glaucoma medication at the third year of the study, the company reported. The company is still in the process of filing for FDA approval for the device as the first minimally invasive stand-alone procedure all states of open-angle glaucoma.

"For us, it's not about pride-of-ownership or name recognition, it's about taking one of the most amazing technologies I've ever been involved with... and it's about getting this to doctors and patients," he said, adding that the more experience surgeons have with the new device, the more they seem to be "over-the-top enthusiastic about it."

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Unlike micro-invasive glaucoma surgery (MIGS), the developing device does not require simultaneous cataract removal, according to the company.

The device has been used to treat more than 250 patients in the United States, Canada, France, Japan, the Netherlands, Spain, Switzerland, and the Dominican Republic.

About Santen, InnFocus

Santen, based in Osaka, Japan, is a Japanese market leader for prescription ophthalmic pharmaceuticals and has their products in more than 50 countries. Santen specializes in research, development, sales, and marketing of ophthalmic pharmaceuticals.

Miami-based InnFocus, founded in 2004, has expertise in biomaterial developments and works on developing glaucoma products.

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