Managing Patient Expectations
Hello. I am Dr. Stefanie Davidson from the Children's Hospital of Philadelphia. I recently returned from the 2014 American Association of Pediatric Ophthalmology and Strabismus (AAPOS) meeting in beautiful Palm Springs, California. I would like to share with you today some of the most interesting papers presented at the meeting.
The 2014 Frank D. Costenbader Lecture was given by Dr. John O'Neill.[1] By retelling his own experience, he provided an insightful and entertaining history of the founding of the AAPOS society. Specifically he described the early formative years of Drs. Frank Costenbader and Marshall Parks, the 2 most influential ophthalmologists in the development of pediatric ophthalmology as a unique and vital specialty.
Dr. Gillian Adams delivered the 2014 Philip Knapp lecture,[2] a lectureship given in the field of ocular motility by a non-North American ophthalmologist. Dr. Adams humbly shared her experience in managing patients who are dissatisfied with their strabismus surgery outcomes. Specifically, she discussed patients whom she considered to have good motor outcomes yet were unhappy postoperatively. Dr. Adams emphasized the importance of talking with patients during the consenting process to ensure that their preoperative expectations are in keeping with postoperative potential. Maintaining an awareness that patients may have emotional or psychological issues contributing to their expectations is extremely important.
Studies on Strabismus Surgery
Dr. Holmes and colleagues from the Mayo Clinic also recognized the importance of patient experience in assessing surgical success. In their study, "The Role of Health-Related Quality of Life When Evaluating Outcomes of Strabismus Surgery,"[3] they examined patients who, despite being designated as failures by motor and diplopia criteria, still report subjective improvement by health-related quality of life (HRQOL) score criteria using the Adult Strabismus 20 questionnaire. They suggest that quantitative HRQOL criteria should be considered when evaluating outcomes after strabismus surgery.
Another strabismus-related study focused on the development of anterior segment ischemia, a rare but serious and vision-threatening complication of strabismus surgery. The effect of rectus muscle recession, resection, and plication on anterior segment circulation in humans studied the impact of strabismus surgery on anterior segment circulation.
In this prospective blinded study of adult patients undergoing strabismus surgery, Oltra and colleagues[4] obtained preoperative and postoperative iris angiograms to study the effect of different surgical procedures on iris perfusion. They found that muscle plication preserves anterior segment circulation compared with rectus muscle recession or resection. They concluded that rectal muscle plication is a safer strengthening procedure than resection in patients with risk factors for anterior segment ischemia. This is important, given that resection is currently the most common strengthening procedure. This study suggests that plication is more effective in avoiding vision-threatening complications in at-risk patients.
Eyes on the iPads
The iPad was the focus of 2 innovative studies, one for vision screening and one for amblyopia treatment.
In their study of the validation of iPad-based simplified visual acuity testing (SVAT) in children, Hee-Jung Park and colleagues[5] reported the results of vision testing with SVAT at 1-meter distance on the iPad. They compared the results with established visual acuity protocols, including the Amblyopia Treatment Study and the electronic EDTRS. The results of iPad simplified visual acuity testing were comparable with these established criteria. The software is easy to use and allows wide distribution for use both in vision screening and in home monitoring of vision by parents. This has the potential to change the way vision screening is performed, bringing access into the home.
The iPad was also a focus for use as an adjunctive amblyopia treatment. Dr. Eileen Birch and her group[6] demonstrated the early promise of binocular iPad treatment for amblyopia in preschool children. With an anaglyphic iPad game that presents reduced contrast to the preferred fixating eye, participants aged 3-6 years were assigned to play 4 hours per week for 4 weeks or to a sham iPad treatment. In addition, 2 hours per day of patching was prescribed to each group. Findings revealed that the binocular iPad game resulted in more visual acuity improvement than the sham iPad group. Patients in the binocular iPad group had a lower rate of amblyopia recurrence at a 3-month post-treatment time interval.
Fluorescein Angiography in ROP
Lastly, a study titled "Serial Fundus Photography and Fluorescein Angiography After Off-Label Intravitreal Bevacizumab Treatment for Retinopathy of Prematurity: Importance of Monitoring Regression by Angiography in Off-Label Bevacizumab Treated Eyes" was delivered by Dr. Luxme Hariharan[7] on behalf of a group from Bascom Palmer. They used beautiful fundus images to elegantly illustrate the importance of using fluorescein angiography to assess the need for further treatment after bevacizumab injection. Active peripheral vessels were not visible on fundus imaging but were clearly apparent with angiography. The revealing images presented convincing evidence that fluorescein angiograms are critical to clearly demonstrate regression or progression of retinopathy of prematurity after treatment of intravitreal bevacizumab.
I'm Dr. Stefanie Davidson from the Children's Hospital of Philadelphia, and I have enjoyed sharing with you some of the most interesting studies presented at the 2014 AAPOS in Palm Springs, California. Thank you
Sunday, May 25, 2014
OPHTHALMOLOGY/IMAGE-GUIDED SURGERY: 'Heads-up' 3D-enabled retinal surgery broadcast live
The visualization platform consisted of a Leica Microsystems (Wetzlar, Germany) M822 ophthalmic microscope with integrated TrueVision 3D (Santa Barbara, CA) technology. The microscope, which enables insertion of tiny light probes into the eye for cataract and retinal surgery, is less invasive than standard technology. It allows observation of the operating field on a monitor rather than through eyepieces, and gives the entire operating team the same field of view as the surgeon. Digital amplification of the camera signal provides visualization of intraocular structures with low-intensity light, lowering the risk of light-induced retinal damage.
Prof. Dr. med. Claus Eckardt used a surgical microscope with integrated heads-up 3D display to perform ophthalmic surgery, which was broadcast live to an audience of 1200 surgeons at Germany's 2014 Frankfurt Retina Meeting. The visualization platform consisted of a Leica Microsystems M822 ophthalmic microscope with integrated TrueVision 3D display technology.
Leica's modular microscopes and proprietary OpenArchitecture allow integration into digital imaging and data systems; TrueVision 3D technology can also be adapted to future surgical guidance applications.
The two companies, whose alliance last year resulted in the first surgical microscope integrated with TrueVision's 3D intelligent visualization technology for neurosurgery, now fuses 3D technology into Leica Microsystems' entire line of ophthalmic microscopes. The expanded relationship, combining optical and digital microscopy into a single platform, is designed to drive precise patient outcomes, enhance surgeon ergonomics, and facilitate surgical staff communication, along with medical education benefits. "This integration creates a seamless, upgradeable platform that will help surgeons gain a more realistic perception of anatomical structures as a result of the depth perceived in 3D," said Dr. Heinrich Dreyer, vice president of Leica Microsystems' Medical Division.
Eckardt said, "I now routinely use 'heads up' 3D surgery in all retinal and cataract cases, and believe many surgeons will perform ophthalmic surgery this way within 5 years." He added that the implication for digital imaging, beyond the obvious ergonomic benefit, is to improve visual outcomes for many ophthalmic surgical procedures, including cataract, cornea, glaucoma, and retina.
Thursday, May 22, 2014
A 'Perfect Storm' in Ophthalmology
Femto Mania Continues: More Choices
Roger F. Steinert, MD: Hello. I am Dr. Roger Steinert, Director of the Gavin Herbert Eye Institute at the University of California, Irvine. By Skype™, I have with me 2 distinguished panelists -- Dr. Steve Lane and Dr. Tom Samuelson -- and we are going to be speaking about some of the highlights of the just-concluded annual meeting of the American Society of Cataract and Refractive Surgery (ASCRS).
Steve, tell us a little bit about yourself.
Stephen S. Lane, MD: My name is Stephen Lane. I'm from St. Paul, Minnesota, where I practice cornea and external disease, as well as refractive surgery and cataract surgery.
Dr. Steinert: Welcome, Steve. And Tom?
Thomas W. Samuelson, MD: My name is Tom Samuelson. I am a glaucoma anterior-segment surgeon in Minneapolis, right across the river from Steve. I have a practice at Minnesota Eye Consultants, and I also teach residents through the University of Minnesota. I am on the clinical faculty at Hennepin County Medical Center.
Dr. Steinert: Thank you both for taking the time to join Medscape.
ASCRS was filled with lots of exciting and new areas. One of the biggest topics still out there is femtosecond ("femto") laser cataract surgery. Steve, what is going on here? Is this still growing? Is it guaranteed to be taking over? Have you heard anything negative?
Dr. Lane: It is a very controversial subject, but certainly the interest continues to grow almost exponentially. Several different laser platforms are now available, and that is probably the most new and exciting development. Physicians in the United States now have a choice of 4 different lasers.
We are starting to see some results. The applicability and adjustability of many of the features are continuing to increase. The technology continues to evolve in a very short period of time. We are seeing an increased number of procedures, and an increased amount of interest.
There is still healthy skepticism and a lot of active debate. Cost probably remains the most significant barrier to the uptick of this technology, but we are starting to see how we can get better results in complicated cases, for example.
It remains a very exciting field. It will be the future (as everybody predicts), but we need to get a better handle on the financial aspects of it under most circumstances for it to continue to gain even more widespread applicability.
Dr. Steinert: Complications are not nonexistent with femto; they seem to be running at about the same level as conventional surgery, even for very skilled surgeons using conventional ultrasound. So, we are moving past that. We have been seeing many more presentations on the technical issues and refinements.
On the exhibit floor, the activity at the booths of the 4 current manufacturers was very high, and it sounds like Ziemer is about to enter the market as well, so pretty soon we may have a fifth platform.
Dr. Lane: I certainly agree with that. We are starting to see this becoming a much more portable type of technology. Buying it and having it stand in your ambulatory surgical center alone is evolving as well. Several companies are making their lasers mobile so that they travel around, and we are seeing that as an increasingly useful modality for people to get experience with it and make a decision about whether they want to purchase the device or use it in a mobile fashion coming off of a van. That seems to be working very well for many ophthalmologists.
Dr. Steinert: That makes it more of a game-changer, because it will make it more affordable as well as more accessible.
A Home Run for Microinvasive Glaucoma Surgery
Dr. Steinert: Equal to the femto mania is the microinvasive glaucoma surgery (MIGS) mania. The whole meeting was filled with the buzz over the innovations in glaucoma surgery. Tom, what's your take on all of this?
Dr. Samuelson: In many respects, it was a home run meeting for glaucoma in general and MIGS in particular. It was a home run in general because Rick Lewis, one of our glaucoma brethren, was honored with the presidency of ASCRS. Then, in the surgical section on glaucoma day, we had nearly 1000 people in the room -- which for glaucoma at an ASCRS meeting is pretty impressive. Of course, nothing is more mainstream at ASCRS than the Binkhorst Lecture, and Ike Ahmed[1] gave a fantastic talk on MIGS. So MIGS had a huge coming-out party at ASCRS, and it was great to see.
Dr. Steinert: Thus far, all of the MIGS has been combined with cataract surgery, yet we know that traditionally, most glaucoma surgery has been separate from cataract surgery. Are these microtechniques going to make their way into non-cataract surgery applications?
Dr. Samuelson: I think they will, but MIGS will probably continue to be centered around cataract surgery. In the past, we decoupled cataract and glaucoma surgery because after we learned that clear corneal phacoemulsification ("phaco") lowered pressure by itself in a large proportion of patients and retained all future surgical glaucoma options, we stopped doing combined procedures except for cases of extremely advanced disease or very high intraocular pressure. We were doing phaco alone for many years for mild to moderate glaucoma, but now that MIGS has evolved, we are using the phaco platform to provide an adjunct to the procedure by adding on a MIGS-plus type of procedure -- whether it is an iStent®, Trabectome®, or endoscopic cyclophotocoagulation.
Ophthalmologists Often Underestimate Glaucoma Risk
Comprehensive ophthalmologists underestimated the likelihood that optic discs had signs of glaucoma almost one-fourth of the time compared with judgments by glaucoma specialists, according to the results of a new study.
Ophthalmology trainees and comprehensive ophthalmologists were twice as likely to underestimate glaucoma likelihood as they were to overestimate it, according to the results of a study published in the May 2014 issue of JAMA Ophthalmology.
Diagnosing glaucoma is challenging, and clinicians often disagree as to whether an optic disc appears to have signs of glaucoma or not. The Glaucomatous Optic Neuropathy Evaluation (GONE) Project aimed to help eliminate diagnostic barriers by gathering information about how clinicians determine whether patients have the condition.
The current study analyzed results from the GONE Project to determine which signs and symptoms most often lead clinicians to make a correct or incorrect glaucoma diagnosis. Ophthalmology trainees, ophthalmologists, and glaucoma specialists registered for the GONE Project from December 2008 through June 2010 and assessed 42 monoscopic optic disc photographs for physiological and glaucoma-related characteristics through an Internet-based system. Clinicians were then asked to assess glaucoma likelihood for each photograph as unlikely, possible, probable, or certain.
The results indicated that both ophthalmology trainees and comprehensive ophthalmologists often underestimated the likelihood of glaucoma. For optic discs that glaucoma specialists judged as having signs of probable or certain glaucoma, ophthalmology trainees underestimated glaucoma likelihood for 22.1% of discs and ophthalmologists underestimated likelihood for 23.8% of discs. Trainees overestimated glaucoma likelihood for 13.0% of the discs, while ophthalmologists overestimated for just 8.9%.
The analysis also found that underestimation of vertical cup-disc ratio and failure to identify retinal nerve fiber layer loss, disc hemorrhage, or rim loss were the most influential factors that led to underestimation of glaucoma. When all of these occurred, the average rate of underestimation of glaucoma likelihood rose to 43.0% among trainees and 42.9% among ophthalmologists. When trainees and ophthalmologists accurately assessed all 4 features, underestimation of glaucoma likelihood significantly decreased, to 10.9% for trainees and 3.1% for ophthalmologists, and overestimation decreased to 2.9% for trainees and 1.6% for ophthalmologists. Overestimation of retinal nerve fiber layer loss, rim loss, vertical cup-disc ratio, cup depth, and disc hemorrhage, and incorrect assessment of disc tilt were all associated with overestimation of glaucoma likelihood. In addition, clinicians were more likely to overestimate glaucoma likelihood in large discs.
“The results of this study will facilitate creation of targeted teaching tools for ophthalmology trainees and continual medical education modules for comprehensive ophthalmologists, focusing on specific aspects of disc examination,” the authors of the study conclude. “We recommend that the assessment parameters be highlighted in optic nerve head examination teaching and continuing medical education modules.”
Ophthalmology trainees and comprehensive ophthalmologists were twice as likely to underestimate glaucoma likelihood as they were to overestimate it, according to the results of a study published in the May 2014 issue of JAMA Ophthalmology.
Diagnosing glaucoma is challenging, and clinicians often disagree as to whether an optic disc appears to have signs of glaucoma or not. The Glaucomatous Optic Neuropathy Evaluation (GONE) Project aimed to help eliminate diagnostic barriers by gathering information about how clinicians determine whether patients have the condition.
The current study analyzed results from the GONE Project to determine which signs and symptoms most often lead clinicians to make a correct or incorrect glaucoma diagnosis. Ophthalmology trainees, ophthalmologists, and glaucoma specialists registered for the GONE Project from December 2008 through June 2010 and assessed 42 monoscopic optic disc photographs for physiological and glaucoma-related characteristics through an Internet-based system. Clinicians were then asked to assess glaucoma likelihood for each photograph as unlikely, possible, probable, or certain.
The results indicated that both ophthalmology trainees and comprehensive ophthalmologists often underestimated the likelihood of glaucoma. For optic discs that glaucoma specialists judged as having signs of probable or certain glaucoma, ophthalmology trainees underestimated glaucoma likelihood for 22.1% of discs and ophthalmologists underestimated likelihood for 23.8% of discs. Trainees overestimated glaucoma likelihood for 13.0% of the discs, while ophthalmologists overestimated for just 8.9%.
The analysis also found that underestimation of vertical cup-disc ratio and failure to identify retinal nerve fiber layer loss, disc hemorrhage, or rim loss were the most influential factors that led to underestimation of glaucoma. When all of these occurred, the average rate of underestimation of glaucoma likelihood rose to 43.0% among trainees and 42.9% among ophthalmologists. When trainees and ophthalmologists accurately assessed all 4 features, underestimation of glaucoma likelihood significantly decreased, to 10.9% for trainees and 3.1% for ophthalmologists, and overestimation decreased to 2.9% for trainees and 1.6% for ophthalmologists. Overestimation of retinal nerve fiber layer loss, rim loss, vertical cup-disc ratio, cup depth, and disc hemorrhage, and incorrect assessment of disc tilt were all associated with overestimation of glaucoma likelihood. In addition, clinicians were more likely to overestimate glaucoma likelihood in large discs.
“The results of this study will facilitate creation of targeted teaching tools for ophthalmology trainees and continual medical education modules for comprehensive ophthalmologists, focusing on specific aspects of disc examination,” the authors of the study conclude. “We recommend that the assessment parameters be highlighted in optic nerve head examination teaching and continuing medical education modules.”
Friday, May 16, 2014
Ohr Pharmaceutical to purchase ophthalmology assets from SKS Ocular
Ohr Pharmaceutical has entered into an agreement to acquire ophthalmology assets from SKS Ocular, the company announced in a news release.
Under the agreement, Ohr will acquire a sustained-release technology platform currently in development. The company will also obtain a line of preclinical sustained-release product candidates for the treatment of glaucoma, retinal disease and other eye diseases.
The transaction is expected to be finalized by the end of the month.
Ohr will make an initial upfront payment of $3.5 million and 1,194,862 shares of its common stock. SKS will be eligible to obtain up to 1,493,578 additional shares of Ohr common stock in staged payments. Payments will be made if the sustained-release delivery platform and product candidates successfully meet specified development and regulatory benchmarks within a specified time interval, the release said.
SKS will also be qualified to receive up to $5 million in cash payments made to Ohr from a research collaboration with a large global pharmaceutical company.
Ohr will also acquire a research team and research laboratory in San Diego.
SKS Ocular’s sustained-release technology uses micro-fabrication techniques to create nanoparticle and microparticle drug formulations that are released for 3 to 6 months.
Under the agreement, Ohr will acquire a sustained-release technology platform currently in development. The company will also obtain a line of preclinical sustained-release product candidates for the treatment of glaucoma, retinal disease and other eye diseases.
The transaction is expected to be finalized by the end of the month.
Ohr will make an initial upfront payment of $3.5 million and 1,194,862 shares of its common stock. SKS will be eligible to obtain up to 1,493,578 additional shares of Ohr common stock in staged payments. Payments will be made if the sustained-release delivery platform and product candidates successfully meet specified development and regulatory benchmarks within a specified time interval, the release said.
SKS will also be qualified to receive up to $5 million in cash payments made to Ohr from a research collaboration with a large global pharmaceutical company.
Ohr will also acquire a research team and research laboratory in San Diego.
SKS Ocular’s sustained-release technology uses micro-fabrication techniques to create nanoparticle and microparticle drug formulations that are released for 3 to 6 months.
2 JAMA Ophthalmology studies focus on glaucoma medication adherence
Electronic monitoring to measure medication adherence by patients with glaucoma documented that a sizable number of patients did not regularly use the eye drops prescribed to them.
Topical medications for glaucoma lower intraocular pressure and can delay or slow the progression of the eye disease. Medication adherence is important.
Patients who were treated with once-daily prostaglandin eye drops were recruited from a university-based glaucoma clinic. Patients were given a container with an electronic cap in which to store their eye drops. The cap recorded each time the container was opened.
Of the 407 patients who completed the three-month adherence assessment, 337 (82.8 percent) took their medication correctly on at least 75 percent of days. The other 70 patients (17.2 percent) (deemed nonadherent) were less likely to be able to name their glaucoma medication, less likely to agree that remembering to use the medication was easy, and more likely to agree with the sentiment that eye drops can cause problems.
"Given that most patients are taking their eye drops as prescribed, identifying patients at risk of nonadherence is a critical step. The results from the patient questions and demographic factors may therefore be useful in creating risk calculators that could find those patients most in need of intervention."
Author: Michael V. Boland, M.D., Ph.D., of the Wilmer Eye Institute at Johns Hopkins University, Baltimore, Md., and colleagues.
(JAMA Ophthalmol. Published online May 15, 2014. doi:10.1001/.jamaopthalmol.2014.856. Available pre-embargo to the media at http://media.jamanetwork.com.)
Editor's Note: This study was supported by a grant from the Microsoft Be Well Fund. Please see article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Automated Text or Voice Messages Help Improve Glaucoma Medication Adherence
An intervention that included text or voice messages appeared to help patients with glaucoma adhere to their eye drop medication.
The barriers to medication adherence by patients with glaucoma are complex. There is a growing body of work on improving adherence.
The 70 nonadherent patients in the related study that assessed medication adherence were randomized to an intervention (n=38) or to a control group (n=32) where they received no additional intervention. The intervention consisted of daily messages, either text or voice, reminding patients to use their glaucoma medication. A personal health record was used to store lists of patient medications and reminder preferences.
The median adherence rate in the 38 patients in the intervention increased from 53 percent to 64 percent. There was no change in the control group. Patients in the intervention (84 percent) agreed the reminders were helpful and that they would continue to use them outside the study. Implementing the intervention is estimated to cost about $20 per year per patient.
"We found that a telecommunication-based reminder linked to a personal health record can increase adherence with once-daily glaucoma medications. This finding is important because it supports an intervention that is feasible in terms of time and cost for a typical ophthalmology practice."
Author: Michael V. Boland, M.D., Ph.D., of the Wilmer Eye Institute at Johns Hopkins University, Baltimore, Md., and colleagues.
(JAMA Ophthalmol. Published online May 15, 2014. doi:10.1001/.jamaopthalmol.2014.857. Available pre-embargo to the media at http://media.jamanetwork.com.)
Editor's Note: This study was supported by a grant from the Microsoft Be Well Fund. Please see article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Wednesday, May 14, 2014
Merck to Sell Some Ophthalmology Assets
Merck & Co. Inc. has reached a deal to sell some ophthalmology assets to Santen Pharmaceutical Co. Ltd. for distribution in Japan as well as markets in the Asia Pacific region and Europe.
Merck will receive a $600 million upfront payment for the sale, as well as additional payments pegged to sales milestones. The deal is expected to close within a few months, Merck said.
The products, which focus on eye treatments and care, generate about $400 million in annual sales in the markets the deal covers, Merck said.
"The decision to divest our ophthalmics business is part of our ongoing strategy to sharpen our commercial focus and improve our operational effectiveness," Merck executive Jay Galeota said in a release.
The Whitehouse Station, N.J., company previously sold its U.S. ophthalmology business to Akorn Pharmaceuticals. It will continue to sell ophthalmology products in Latin America, Canada, Australia, the Middle East and Africa, among other markets.
Japan'sSanten said it expects to use a combination of loans and cash to fund the deal, which it projects as adding to earnings starting in March 2015.
The deal comes amid a flurry of deal-making in the drug industry, including Merck's agreement earlier this month to sell its over-the-counter business to Bayer AG for $14.2 billion.
Merck will receive a $600 million upfront payment for the sale, as well as additional payments pegged to sales milestones. The deal is expected to close within a few months, Merck said.
The products, which focus on eye treatments and care, generate about $400 million in annual sales in the markets the deal covers, Merck said.
"The decision to divest our ophthalmics business is part of our ongoing strategy to sharpen our commercial focus and improve our operational effectiveness," Merck executive Jay Galeota said in a release.
The Whitehouse Station, N.J., company previously sold its U.S. ophthalmology business to Akorn Pharmaceuticals. It will continue to sell ophthalmology products in Latin America, Canada, Australia, the Middle East and Africa, among other markets.
Japan'sSanten said it expects to use a combination of loans and cash to fund the deal, which it projects as adding to earnings starting in March 2015.
The deal comes amid a flurry of deal-making in the drug industry, including Merck's agreement earlier this month to sell its over-the-counter business to Bayer AG for $14.2 billion.
Santen to purchase Merck’s ophthalmology products in Japan and Europe, Asia-Pacific markets
Santen Pharmaceutical and Merck have entered into an agreement by which Santen will purchase Merck’s ophthalmology products in Japan and key markets in Europe and Asia-Pacific.
Under the agreement, Santen will purchase Cosopt (dorzolamide hydrochloride–timolol maleate ophthalmic solution), Cosopt PF (dorzolamide hydrochloride-timolol maleate ophthalmic solution 2%/0.5%), Trusopt (dorzolamide hydrochloride ophthalmic solution sterile ophthalmic solution 2%), Trusopt PF (preservative-free dorzolamide hydrochloride ophthalmic solution), Timoptic (timolol maleate ophthalmic solution), Timoptic PF (timolol maleate preservative-free ophthalmic solution in unit dose dispenser), Timoptic XE (timolol maleate ophthalmic gel forming solution), Saflutan (tafluprost) and Taptiqom (tafluprost-timolol maleate ophthalmic solution), according to news releases from the companies.
Santen will make an initial payment of about $600 million and subsequent payments based on defined sales benchmarks.
The agreement hinges on closing conditions such as Santen getting antitrust clearance in Japan and other caveats related to specific markets or regions. The agreement is expected to close later this year.
“Santen is proud to inherit and continue Merck’s formidable legacy in ophthalmology,” Akira Kurokawa, president and CEO of Santen Pharmaceutical, said in the Santen release.
Annual sales of the ophthalmology products covered by the agreement are approximately $400 million, according to the Merck release.
“The decision to divest our ophthalmics business is part of our ongoing strategy to sharpen our commercial focus and improve our operational effectiveness,” Jay Galeota, Merck president for Hospital and Specialty Care, said in the release. “This transaction provides products that complement Santen’s portfolio and is designed to ensure continued access for physicians and patients to these medicines around the world.”
Last year, Merck divested its U.S. ophthalmology business to Akorn Pharmaceuticals. Merck will still sell ophthalmology products in Latin America, Canada, Australia, the Middle East, Africa and other markets, the Merck release said.
Under the agreement, Santen will purchase Cosopt (dorzolamide hydrochloride–timolol maleate ophthalmic solution), Cosopt PF (dorzolamide hydrochloride-timolol maleate ophthalmic solution 2%/0.5%), Trusopt (dorzolamide hydrochloride ophthalmic solution sterile ophthalmic solution 2%), Trusopt PF (preservative-free dorzolamide hydrochloride ophthalmic solution), Timoptic (timolol maleate ophthalmic solution), Timoptic PF (timolol maleate preservative-free ophthalmic solution in unit dose dispenser), Timoptic XE (timolol maleate ophthalmic gel forming solution), Saflutan (tafluprost) and Taptiqom (tafluprost-timolol maleate ophthalmic solution), according to news releases from the companies.
Santen will make an initial payment of about $600 million and subsequent payments based on defined sales benchmarks.
The agreement hinges on closing conditions such as Santen getting antitrust clearance in Japan and other caveats related to specific markets or regions. The agreement is expected to close later this year.
“Santen is proud to inherit and continue Merck’s formidable legacy in ophthalmology,” Akira Kurokawa, president and CEO of Santen Pharmaceutical, said in the Santen release.
Annual sales of the ophthalmology products covered by the agreement are approximately $400 million, according to the Merck release.
“The decision to divest our ophthalmics business is part of our ongoing strategy to sharpen our commercial focus and improve our operational effectiveness,” Jay Galeota, Merck president for Hospital and Specialty Care, said in the release. “This transaction provides products that complement Santen’s portfolio and is designed to ensure continued access for physicians and patients to these medicines around the world.”
Last year, Merck divested its U.S. ophthalmology business to Akorn Pharmaceuticals. Merck will still sell ophthalmology products in Latin America, Canada, Australia, the Middle East, Africa and other markets, the Merck release said.
Monday, May 12, 2014
Association for Research in Vision and Ophthalmology, May 4-8 (Ophthalmology)
The annual meeting of the Association for Research in Vision and Ophthalmology was held from May 4 to 8 in Orlando, Fla., and attracted more than 12,000 participants from around the world, including clinicians, academicians, allied health professionals, and others interested in vision and ophthalmology. The conference highlighted recent advances in vision and ophthalmology, with presentations focusing on the latest research in amblyopia, cataracts, glaucoma, macular edema, myopia, age-related macular degeneration, and diabetic retinopathy.
In one study, Carla B. Mellough, M.D., of Newcastle University in the United Kingdom, and colleagues found that the production of specialized eye tissues from human stem cells can be achieved using a simplified and reproducible method, while also indicating a potential role for this growth factor in human eye development. To investigate the role of this growth factor in eye specification, the investigators pharmacologically inhibited its signaling pathway in stem cells and found a significant reduction in the development of optic structures, revealing an important role for this factor in the differentiation of eye tissues in the laboratory.
"Many forms of blindness remain untreatable, so the ability to have access to the specialized tissue of the eye is extremely valuable for studying disease, drug effectiveness, or cell transplantation in order to develop new treatments," said Mellough. "The reproducible production of this tissue from human stem cells, which can be created in the laboratory and closely resembles the tissue in humans, offers incredible opportunity for groundbreaking research with clinical impact."
In another study, Julia E. Richards, M.D., of the University of Michigan-Kellogg Eye Center in Ann Arbor, and colleagues evaluated whether use of metformin could reduce the risk of open-angle glaucoma.
"When studying a population of diabetes patients, we found that use of metformin reduced the hazard of open-angle glaucoma by about 25 percent over a two-year period," said Richards. "This reduced hazard of glaucoma was seen when glycemic control (monitored by HbA1c level) was taken into account, and we also found that other diabetes medications were not associated with a reduction in hazard of developing open-angle glaucoma. This suggests that the reduced hazard might be the result of metformin's known impact on aging pathways and processes, and may not be a simple result of glycemic control."
Lisa J. Faia, M.D., of the Oakland University School of Medicine in Rochester, Mich., and colleagues found that patients with wet age-related macular degeneration and the presence of a posterior vitreous detachment required fewer injections of ranibizumab. Patients without a posterior vitreous detachment were two times more likely to need additional injections after the initial three than those who had a posterior vitreous detachment.
"The presence of a posterior vitreous detachment may play a role in treating patients with wet age-related macular degeneration when it comes to the number of injections involved. Larger, prospective studies are needed," said Faia. "If we could reduce the number of injections needed for treating wet age-related macular degeneration, the impact would not only be seen on a financial level but also on a patient comfort level as well."
Robert E. MacLaren, M.D., of the University of Oxford in the United Kingdom, and colleagues found that gene therapy can be applied safely early on in the progress of a retinal disease and before the onset of central vision loss. The investigators evaluated the efficacy of gene therapy using an adeno-associated viral (AAV) vector in six patients with a genetic cause of blindness known as choroideremia.
"The group of six patients had a mean improvement in retinal sensitivity in their ability to see a dim light stimulus noted six months later. The two patients with more advanced disease gained several lines of visual acuity and this has been sustained up to two years so far," said MacLaren. "The trial is ongoing, with three patients now injected with the higher dose. The initial results confirm that the viral vector is working, but it is still too early to know if the treatment will slow or stop the degeneration."
Ryoichi Arita, M.D., of Kyushu University in Fukuoka, Japan, and colleagues investigated the effect of the Rho-associated protein kinase inhibitor K-115 on neovascularization and vessel loss in oxygen-induced retinopathy (OIR) mice. The investigators found that topical application of K-115 significantly reduced retinal neovascular area and avascular area in OIR mice.
"We also investigated the impact of K-115 on vascular endothelial growth factor (VEGF)-induced vascular hyperpermeability in endothelial cells and VEGF transgenic mice," said Arita. "Another key result was that K-115 could inhibit VEGF-A-induced tight junction disruption in vitro, and the topical K-115 treatment could reduce VEGF-induced vascular permeability and retinal edema in vivo."
Several authors disclosed financial relationships with the Kowa company.
Three Singapore docs among top 100 most influential people in ophthalmology
Professor Donald Tan, medical director of the Singapore National Eye Centre, is third among the Who's Who in eye care. He is cited for his roles in myopia trials, cornea surgery and transplant. Prof Tan holds the patent to an instrument that is now widely used in eye transplants.
Singapore is a leading eye transplant centre, and Prof Tan said it has trained more than 70 surgeons from 16 countries in the technique.
Only the top 20 people are ranked.
Wednesday, May 7, 2014
Regeneron Inks Ophthalmology Deal
Under the terms of the deal, the private entity will receive an upfront payment in cash and contingent payments totaling up to $640 million following the achievement of certain development and regulatory milestones. Furthermore, Regeneron will have to shell out royalties on global net sales of drugs emanating from the partnership, which covers up to eight distinct therapeutic targets. Regeneron is entitled to exclusive global rights to each candidate under clinical development.
Moreover, the ophthalmology deal grants Avalanche the option to share costs of development and profits (following approval) with Regeneron pertaining to two collaboration therapeutic targets selected by the private entity. Furthermore, Regeneron will get a time-limited option to acquire rights to Avalanche‘s ophthalmology candidate AVA-101 following the completion of its phase IIa study in wet age-related macular degeneration (AMD).
Our Take
We are positive on the deal inked by Regeneron, which has already tasted stupendous success with its eye drug Eylea. The first approved indication for Eylea was wet AMD, the same indication for which AVA-101 is being studied. Regeneron is aiming to enhance its position in the lucrative ophthalmology market by successfully developing candidates under the deal.
We are highly optimistic about the success of the deal since Regeneron is vastly experienced in developing and subsequently commercializing eye disorder treatments as can be gauged by Eylea’s success. Regeneron has a partnership with Bayer (BAYRY - Analyst Report) on Eylea.
Regeneron carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biopharma space include Alexion Pharmaceuticals (ALXN - Analyst Report) and Gilead Sciences (GILD - Analyst Report). Both stocks carry a Zacks Rank #1 (Strong Buy).
Glaucoma Risk Underestimated by Ophthalmologists, Trainees
Evelyn C. O'Neill, MBBCh, MD, from the Centre for Eye Research Australia, University of Melbourne, East Melbourne, Victoria, and colleagues conducted the study involving training and practicing ophthalmologists from 22 countries who participated in the Glaucomatous Optic Neuropathy Evaluation (GONE) Project between December 1, 2008, and June 30, 2010.
GONE is a self-assessment program that presents 42 monoscopic optic disc photographs chosen from 2500 healthy and glaucomatous optic discs to represent a range of physiological and glaucomatous characteristics. Participants grade 9 topographic features and clinical features associated with the retinal nerve fiber layer. They then assess glaucoma likelihood, using a 4-point scale ranging from unlikely to possible, to probable, to certain. The program has a time limit of 90 seconds for each image.
Trainees and practicing ophthalmologists have learned about GONE through conference presentations, publications, and word of mouth. The current analysis includes participants who self-registered and completed assessment of the 42 discs between December 1, 2008, and June 30, 2010. Of 197 participants, 109 were trainees, 51 were comprehensive ophthalmologists, and 37 were glaucoma subspecialists.
For optic discs that glaucoma subspecialists graded as probable or certain glaucoma, ophthalmology trainees underestimated glaucoma likelihood in a mean of 22.1% of discs compared with comprehensive ophthalmologists, who underestimated the likelihood in a mean of 23.8% of discs.
For optic discs that glaucoma subspecialists graded as possible or unlikely glaucoma, trainees overestimated glaucoma likelihood in a mean of 13.0% of discs compared with a mean of 8.9% discs for comprehensive ophthalmologists.
4 Main Disc Characteristics
The researchers used multivariable linear regression analysis to determine which optic disc characteristics had the greatest effect on assessments. They found 4 characteristics that had the most influence: retinal nerve fiber layer loss, rim loss, hemorrhage, and vertical cup:disc ratio (P < .01).
When participants correctly assessed those 4 characteristics, underestimation of glaucoma likelihood fell to 10.9% for trainees and 3.1% for comprehensive ophthalmologists, and overestimation dropped to 2.9% and 1.6%, respectively.
However, when participants incorrectly assessed all 4 of these characteristics, the mean percentage of discs underestimated for glaucoma likelihood rose to 43.0% for trainees and 42.9% for comprehensive ophthalmologists, with no significant change in overestimation.
"The most important take-home message from this paper is the importance of accurate assessment of the optic nerve head and [retinal nerve fiber layer] in the diagnosis and monitoring of glaucoma. When these are inappropriately assessed, diagnoses may be missed," Dr. O'Neill told Medscape Medical News. "We all know population-based screening for glaucoma is not cost effective or efficient; thus, I would recommend improved awareness and case detection through screening of high-risk individuals and better assessment of the optic nerve head in all patients attending ophthalmic services."
She added, "One surprise result in this study was that small disc size did not increase the underestimation of glaucoma likelihood. This may have been due to sample size. However, it was unexpected."
"This paper outlines specific areas in optic nerve assessment that are associated with the grader making a false diagnosis," co-investigator Jonathan G. Crowston, PhD, MBBS, head of glaucoma research and managing director of the Centre for Eye Research Australia, and senior author, added. "In learning or teaching optic nerve assessment, we can focus on specific aspects of the examination that deserve special attention to avoid making a false diagnosis."
Underdiagnosis Is "Biggest Surprise"
"The results of the study weren't a huge surprise, in the sense that we already knew there was a lot of variability among different people who evaluate the optic nerve," Brian Song, MD, a glaucoma specialist at the Massachusetts Eye and Ear Infirmary and instructor in ophthalmology at Harvard Medical School, Boston, told Medscape Medical News.
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