Article Date: 7/1/2013

News Spectrum
NEWS spectrum

Valeant to Acquire B+L

Valeant Pharmaceuticals International, Inc. and Bausch + Lomb (B+L) Holdings, Inc. recently announced that they have reached an agreement for Valeant’s acquisition of B+L for $8.7 billion. B+L will retain its name, as a division within the parent company.

Under terms of the agreement, which was unanimously approved by the Board of Directors of both companies, Valeant will pay aggregate consideration of $8.7 billion in cash, of which approximately $4.5 billion will go to an investor group led by Warburg Pincus and approximately $4.2 billion will be used to repay B+L’s outstanding debt.

Valeant is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, neurology, and branded generics. It will integrate its existing ophthalmology businesses into the B+L division.

Valeant management views the acquisition of B+L as an opportunity to capitalize on growing eye healthcare trends driven by an aging patient population, growing numbers of consumers who have diabetes, and increasing demand in emerging markets. In addition, it expects to benefit from B+L’s strong product portfolio and late stage pipeline of innovative eyecare products and devices.

The transaction, which is expected to close in the third quarter, is subject to customary closing conditions and regulatory approvals.

Following the closing, B+L’s CEO Brent Saunders will join Valeant in an advisory role to help ensure a seamless transition and integration, and Fred Hassan, chairman of B+L’s Board of Directors, will join Valeant’s Board of Directors.

In addition, Dan Wechsler, executive vice president and president of B+L’s Global Pharmaceuticals, will join Valeant as executive vice president and company group chairman, Ophthalmology and Eye Health. B+L’s Chief Medical Officer Calvin W. Roberts, MD, will also join Valeant as its chief medical officer, Ophthalmology and Eye Health.

B+L also anticipates that additional members of its senior management team will join Valeant.

Lagado Obtains FDA Clearance for Latheable Silicone Hydrogel Material

Lagado Corporation, a subsidiary of Menicon America, Inc., has received FDA clearance to use its new latheable silicone hydrogel material Lagado LSH (mangofilcon A) in contact lenses.

This mid-range water content (49 percent) material can be utilized in a wide variety of designs. Lagado LSH contact lenses will be plasma oxidized to produce a low wetting angle and improved wettability, helping to promote lens comfort, improve visual performance, and reduce the potential for deposits. In addition, Lagado says that the new material has a unique combination of physical properties that make it stable, durable, and easy to handle.

In the U.S. market, Lagado will begin working with a select group of independent custom lens laboratories. Each lab will be required to submit and receive FDA clearance for contact lenses offered in the Lagado LSH material. The company anticipates that Lagado LSH contact lenses will be available later this year.

Cagle Joins GrayBug, LLC

GrayBug, LLC, a company that develops ophthalmic drug delivery systems as well as its own drugs to treat eye disease, has announced that Gerald D. Cagle, PhD, has joined the company as senior advisor and head of business development.

For the past 13 years, Dr. Cagle held the position of chief scientific officer at Alcon Laboratories. Over his 35-year career, he has had broad managerial, technical, and business experience, with positions that have encompassed laboratory science, clinical research, regulatory affairs, and product development. He has directed or coauthored new drug applications and premarket approvals that have led to more than 100 new Alcon products.

GrayBug is a platform drug delivery company that is developing proprietary controlled release technologies for ophthalmic pharmaceutical indications. GrayBug also has a proprietary platform technology that allows sustained drug delivery into various compartments of the eye.

Ista Pharmaceuticals Reaches Settlement

Bausch +Lomb (B+L) announced that its recently acquired subsidiary Ista Pharmaceuticals has reached an agreement with the Federal government in a case alleging conspiracy to introduce a misbranded drug in interstate commerce as well as other related charges.

Ista pled guilty to illegal activity that occurred during the time period from January 2006 to March 2011 involving its product Xibrom. The ophthalmic, nonsteroidal, anti-inflammatory drug was approved by the FDA to treat pain and inflammation following cataract surgery. In the agreement, Ista acknowledged that it had promoted the use of Xibrom for non-FDA approved purposes in interstate commerce, and that the company had violated statutes prohibiting kickbacks.

B+L acquired Ista in 2012 and was not involved in the litigation. The corporation will integrate Ista’s portfolio of ophthalmic pharmaceuticals and related operations and will wind down Ista’s corporate entity by the end of 2013.

BCLA Hosts 37th Annual Meeting

The British Contact Lens Association (BCLA) welcomed 1,242 delegates and exhibition visitors from more than 40 countries to its 37th Clinical Conference and Exhibition, held at Manchester Central from June 6 to 9. Attendance figures were slightly higher than those for the 2012 event, which drew 1,203 delegates and visitors. With 55 companies exhibiting, BCLA reports that it was the organization’s largest exhibition, with the highest attendance in its history.

The exhibit hall also displayed the 80 entries in this year’s poster competition. The overall winners were Maria Navascues-Cornago, Carole Maldonado-Codina, and Philip Morgan for their poster on ‘Sensitivity of the marginal and tarsal conjunctiva in non-contact lens wearers.’

The winner of the 2013 photographic competition was Fabrizio Zeri, who received a digital camera courtesy of competition sponsor Nikon Optical for his entry ‘Hyperferritinemia cataract.’

The 2013 Conference Programme featured four days of education on topics including myopia, dry eye, keratoconus, lens material advancements, and lens comfort, among many others. Award winners at this year’s conference included:

▸BCLA Medal Award: Judith Morris

▸Irving Fatt Memorial Lecture: Dr. Mitra Tavakoli

Dallos Award: Gurpal Singh Toor

Da Vinci Award: Ka Ya Chan

New this year was BCLA Business Day, themed, ‘Understanding the business of contact lenses.’ Topics included the customer journey and maximizing online opportunities. Also new for 2013 were peer review and peer discussion, which included delegate participation.

The 38th BCLA Clinical Conference and Exhibition will take place at the ICC Birmingham, UK, from June 6 to 9, 2014. The 2014 Keynote Speakers will include:

▸BCLA Medal Lecture: Dr. Philip Morgan (UK)

▸Irving Fatt Memorial Lecture: Heiko Pult (Germany)

▸Professor Lyndon Jones (UK/Canada)

▸Dr. Motozumi Itoi (Hong Kong).

CooperVision Debuts MyDay at BCLA Event

CooperVision introduced its new MyDay daily disposable contact lenses at the British Contact Lens Association (BCLA) Clinical Conference and Exhibition in June. MyDay lenses incorporate the company’s latest understanding of daily disposable lens wearing habits, practitioner demands, and advances in materials science.

The lenses feature a chemical structure called Smart Silicone (stenfilcon A) that creates efficient channels for oxygen delivery to the cornea. With less silicon needed to achieve the desired oxygen permeability levels, the efficient silicone network allows for more hydrophilic materials. The result is improved lens surface wettability, higher water content, and lower, hydrogel-like modulus for a softer, more comfortable wearing experience, according to the company.

The lenses are expected to be available initially in Europe by September 2013, with rollouts in other global markets beginning in 2014.



INDUSTRY BRIEFS

■ SynergEyes is expanding the available parameters for its Duette HD hybrid lens to include a flatter base curve and higher plus powers. The new parameters include an 8.3mm base curve and plus powers up to +10.00D.

■ To promote July as Dry Eye Disease Awareness Month, TearLab has launched a program intended to keep dry eye disease top of mind for office staff and to encourage discussion with patients. The promotion includes patient materials designed to raise awareness about their condition and to encourage conversation with their practitioners. In addition, web banners are available to promote dry eye awareness on practice websites, and on-hold scripts and point-of-care materials are available. A patient satisfaction program will also provide feedback to practices.

■ The Program Committee of the Global Specialty Lens Symposium invites the submission of papers, posters, and photographs for its 2014 meeting, which will take place Jan. 23 to 26, 2014 at the Rio All Suites Hotel and Casino in Las Vegas. Papers and abstracts related to presbyopia, keratoconus, corneal topography, post-penetrating keratoplasty or irregular cornea, myopia control, orthokeratology, and lens care topics are welcome. To enter the photo contest, submit up to two (2) photographic images in the following anterior segment categories: Contact Lens and Cornea/Conjunctiva/Lids. Contestants may also submit images obtained through such equipment as optical coherence tomographers, topographers, etc. Those interested in submitting can visit the website at www.GSLSymposium.com. Web submissions only. Deadline for submissions is Aug. 31, 2013.

■ A clinical and experimental study reported in the May 25, 2013 Ophthalmology found a new anatomical feature within the eye—a new layer located at the back of the cornea between the corneal stroma and Descemet’s membrane. Only 15 microns in thickness, the well-defined, acellular Dua’s Layer is named after Dr. Herminder Dua, the lead scientist from the University of Nottingham who is responsible for the discovery. It is expected that this advancement in the understanding of the corneal structure will allow practitioners to better diagnose and treat certain conditions and dramatically improve outcomes for patients undergoing corneal grafts and implants.

Prevent Blindness America announced the recipient of its Tenth Annual Investigator Award, Lyne Racette, PhD, assistant professor at the Eugene and Marilyn Glick Eye Institute, Department of Ophthalmology at Indiana University. She received the award for her work in analyzing the effectiveness of motivational interviewing in improving adherence to glaucoma treatment in patients of African descent. Motivational interviewing attempts to elicit from each patient the strategy that is most likely to ensure that they will adhere to their treatment regimen.

CooperVision has reached an agreement to sell Aime, its GP contact lens and solutions business in Japan, to Nippon Contact Lens Inc. Financial terms of the transaction were not disclosed. According to the company announcement, the decision to divest Aime is consistent with CooperVision’s strategy to focus on its core soft contact lens business. The Aime business was obtained in 2010 as part of a successful acquisition, which included obtaining the rights to sell Biofinity in Japan. The divestiture is subject to numerous closing conditions and is expected to close during Cooper’s fourth quarter of fiscal 2013.

AllAboutVision.com now offers free eye health videos for practitioner websites. These embeddable videos provide website visitors with an entertaining and educational resource, according to All About Vision. The four videos available to practitioners cover the basics of astigmatism, cataract surgery, blurry vision, and preventing eye injuries. Interested practitioners can sign up by visiting AllAboutVision.com’s Eye Care Professional portal to fill out a video request form.

Haag-Streit USA recently signed an agreement with BuyMD.net, naming it an independent sales company serving Virginia, North Carolina, and South Carolina for Haag-Streit USA’s new Surgical Division. Haag-Streit USA Surgical Division markets a line of surgical microscopes throughout Europe. Formerly known as Möller-Wedel, the devices are now being offered in the United States under the new Haag-Streit Surgical brand. Visit www.haag-streitusa.com or call (800) 787-5426.

Rigel Pharmaceuticals, Inc. has developed a topical ophthalmic (eye drop) formulation of R348, a JAK/SYK inhibitor, aimed at reducing the underlying inflammation responsible for causing the symptoms of dry eye disease. According to the company, a recently completed Phase 1 study of R348 in patients who have dry eye disease showed that the drug candidate is well tolerated. Rigel expects to soon begin a Phase 2 study, titled DROPS (Dry eye Rigel Ophthalmic Phase 2 Study).

■ The American Academy of Ophthalmology has established the Sunil K. Rao, MD, Memorial Retina Fellowship Award, which provides funding for two retina fellows to attend the 117th Annual Meeting of the Academy on Nov. 16 to 19 in New Orleans. The application process will conclude on July 15, 2013. For more information, visit www.faao.org/Rao-Fellowship.cfm. The fellowship honors Dr. Sunil K. Rao, a retina specialist who taught and practiced ophthalmology with expertise and enthusiasm and was renowned for his generosity. Dr. Rao trained at Brown University and completed his medical and surgical vitreoretinal fellowship at The New York Eye and Ear Infirmary. He passed away suddenly in 2012 at age 34.

■ The provision of eye care in Haiti was improved with the official opening of the Vision Plus Clinic in Cap Haitien, Haiti. The project is an initiative of the International Eye Foundation and Vision for the Poor with support from a number of eyecare charities including Optometry Giving Sight.



Contact Lens Spectrum, Volume: 28 , Issue: July 2013, page(s): 3 - 9 52