Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced it will make its first milestone payment to ForSight VISION4, Inc. as part of an exclusive license agreement to develop the company's investigational drug delivery device, designed to provide sustained delivery of Lucentis® (ranibizumab).
Genentech and Roche entered into an agreement with ForSight VISION4 in December 2010 for exclusive worldwide rights to the company's proprietary implantable ocular device in the development and commercialization of anti-VEGF-A targeted ophthalmic therapies. This first undisclosed milestone payment is based on Genentech's decision to submit an Investigational New Drug (IND) application for clinical testing of the device in combination with Lucentis. Currently, Lucentis, which is indicated for treatment of certain eye diseases, is recommended to be administered by monthly injections to the eye.
"This development reflects Genentech's commitment to ophthalmology and investigating new technologies that may potentially provide sustained delivery of Lucentis and reduce the frequency of injections," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "The license agreement with ForSight VISION4 represents part of our ongoing strategy to support the retinal community by innovating and discovering new ways to help people with sight-threatening illnesses."
The agreement provides Genentech with the opportunity to apply the device to other select targets for treatment of ophthalmic diseases. Genentech is responsible for clinical development and commercialization and is currently collaborating with ForSight VISION4 in the manufacturing and engineering of the device. ForSight VISION4 is entitled to undisclosed milestone payments and royalties on potential future sales.
"The ForSight VISION4 technology has the potential to revolutionize the way we treat ophthalmic disease," said Eugene de Juan, Jr., M.D., founder of ForSight VISION4, Inc. "Genentech is an ideal partner given their long-term clinical experience with Lucentis and pioneering work in the anti-VEGF therapeutic space."
The device is a refillable drug port delivery system (PDS) designed to release Lucentis over a period of months.
Lucentis is currently FDA-approved to treat two eye conditions that can potentially lead to vision loss and blindness: neovascular (wet) age-related macular degeneration (AMD), which affects an estimated 1.6 million U.S. adults over the age of 501, and macular edema following retinal vein occlusion (RVO), which affects more than 1 million people in the U.S.2
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor which was first approved by the FDA for the treatment of wet AMD in 2006 and for macular edema following RVO in 2010. A supplemental Biologics License Application (sBLA) for Lucentis for the treatment of patients with diabetic macular edema (DME) is currently under review by the FDA.
Lucentis is designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. In wet AMD, these blood vessels grow under the retina and leak blood and fluid, causing rapid damage to the macula. In RVO, angiogenesis and hyperpermeability can lead to macular edema, the swelling and thickening of the macula.
In wet AMD clinical trials, Lucentis administered monthly demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) treated monthly with Lucentis in those trials maintained (defined as losing < 15 letters) vision.
In Phase III clinical trials studying macular edema following RVO, studies showed that Lucentis administered monthly demonstrated an early (day seven) and sustained vision improvement of three lines or more on the study eye chart during the six-month controlled treatment period of the studies.
Lucentis (lucentis.com) is a prescription medication given by injection into the eye, and it has side effects. Lucentis is not for everyone. Lucentis should not be used in patients who have an infection in or around the eye or are allergic to Lucentis or any of its ingredients.
Some Lucentis patients have serious side effects related to the injection. These include serious infections inside the eye, detached retinas, and cataracts. Other uncommon serious side effects include inflammation inside the eye and increased eye pressure. These can make a patient's vision worse. Some patients have increases in eye pressure within one hour of an injection. A patient¿s eye doctor should check the eye pressure and eye health during the week after a Lucentis injection.
Although not common, Lucentis patients have had blood clot-related serious side effects (heart attacks, strokes, and death).
If a patient's eye becomes red, sensitive to light, painful, or there is a change in vision, patients should call or visit their eye doctor right away.
The most common side effects in the eye are increased redness in the whites of the eye, eye pain, small specks in vision, and the feeling that something is in the eye. The most common non-eye-related side effects are nose and throat infections, headache, and respiratory (lung) infections. Lucentis is for prescription use only.
Lucentis was discovered by Genentech and is being developed by Genentech in the U.S. for diseases or disorders of the eye.
Founded more than 30 years ago, Genentech (gene.com) is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.
About ForSight VISION4
ForSight VISION4, Inc., the fourth company to spin out of the ophthalmic incubator ForSight Labs, LLC (forsightlabs.com), was founded in June of 2009 and is funded by two of the leading venture capital firms: Morgenthaler Ventures (morgenthaler.com) and Versant Ventures (versantventures.com). Located in Menlo Park, California, ForSight Labs, LLC, focused on developing impactful solutions to improve the sight, care, and quality of life of visually impaired patients, was established in 2005 by renowned ophthalmologist and retinal surgeon Eugene de Juan, Jr. M.D. in collaboration with The Foundry (thefoundry.com).
1 Melniknva, Irena, Wet age-related macular degeneration, Nature Reviews Drug Discovery 4, 711-712, September 2005.
2 Genentech data on file (Based on population-based studies/the Beaver Dam Eye Study 2000 and 2008 and the U.S. Census).