Allergan Inc. is a step closer to expanding its lower-face filler lineup.
The Irvine drug maker said this month that a Food and Drug Administration advisory committee voted that the benefits of its Juvéderm Voluma XC filler for augmenting cheeks outweigh the risks.
Allergan is looking to market the product for restoring cheek volume lost over time. Juvéderm Voluma XC is made of hyaluronic acid, a moisturizing agent naturally found in the skin.
The General and Plastic Surgery Devices Panel of the FDA’s Medical Devices Advisory Committee made the recommendation. Allergan said that although it’s a nonbinding recommendation, the larger agency will consider it in the final-approval decision.
“Allergan is committed to working with the FDA as they continue our review of our [premarket application] for Juvéderm Voluma XC,” said Scott Whitcup, Allergan’s executive vice president, research and development, and chief scientific officer, in a news release.
If the FDA approves the product, Allergan said it plans to introduce it late this year. The company added that Juvéderm Voluma XC would be the only dermal filler sold in the U.S. for filling cheeks that have lost fullness with age.
“Facial aesthetics,” under which the Juvéderm line and other lower-face skin fillers fall, accounted for $111.1 million, or 8%, of Allergan’s total product sales of $1.43 billion in the first quarter.
Allergan has forecast total filler sales this year at between $410 million to $440 million.
Juvéderm Voluma “is an underappreciated share-gaining opportunity for [Allergan’s] filler franchise,” said Seamus Fernandez, an analyst with Boston-based investment bank Leerink Swann LLC, in a client note issued ahead of the panel’s recommendation.
Fernandez wrote that he “conservatively” forecasts domestic sales of Juvéderm Voluma to reach $148 million by 2020.
The note mentioned that doctors are enthusiastic about the product’s prospects.
Feedback from Leerink’s MedaCorp research arm in the U.S. and “key opinion leaders” in Europe “has been universally positive,” Fernandez said, “with the opportunity to open up a completely new market.”
Juvéderm Voluma may end up leading the full-face reshaping market, according to Fernandez.
Other dermal fillers used in the market are Merz Pharmaceuticals Inc.’s Radiesse and Sculptra, the latter of which is offered by Canadian drug maker Valeant Pharmaceuticals International Inc., a company that had its origins in Orange County. Valeant got Sculptra in its $2.6 billion buy of Scottsdale, Ariz.-based Medicis Pharmaceutical Corp. at the end of 2012.
Bausch & Lomb’s New Lens
Rochester, N.Y.-based Bausch & Lomb Inc., a diversified eye health company with a surgical unit in Aliso Viejo, introduced Incise, a new intraocular lens used in cataract surgery.
Incise is implanted in a patient’s eye through an incision of less than 2 millimeters.
Bausch said Incise has several features “to deliver an enhanced experience for both the surgeon and patient and ultimately better outcomes.” Among other things, the company said the lens is designed to minimize a condition called posterior capsular opacification, which can cloud patients’ vision after surgery.
Incise is used in combination with Stellaris, a Bausch & Lomb line of machines and instruments used in eye surgeries.
Bausch’s surgical unit in Orange County has some 200 workers. The company, which has filed for an initial public offering, made OC its eye device hub after it bought Aliso Viejo-based intraocular lens maker Eyeonics Inc. in 2008.
Renovated Medical Office in Mission Viejo
Fallbrook-based Stephens Construction and Development and Sillman Wright Architects of San Diego have renovated an 8,000-square-foot office building at 26401 Crown Valley Parkway in Mission Viejo for Community Orthopedic Medical Group. The project is valued at $2.1 million.
The work included relocating the practice’s physical therapy department, as well as moving its magnetic resonance imaging unit from an adjacent building and creating space to allow for the installation of a larger MRI machine.
Bits and Pieces
Irvine-based PathCentral Inc. said that the pathology department of Johns Hopkins University School of Medicine will participate in its PathCentral Pathology Network. The network is an online information and digital consultation forum. … Dr. Brian Solow, chief medical officer of pharmacy benefit manager OptumRX, recently spoke at a forum presented by the Pharmacy Benefit Management Institute in Chicago. Solow works out of OptumRX’s Irvine office; OptumRX is a unit of Minnesota-based UnitedHealth Group Inc.
