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FDA APPROVES AVEDRO SYSTEMS FOR CXL
Avedro has received approval from the US Food and Drug Administration (FDA) for Photrexa Viscous, Photrexa and the KXL System. Photrexa Viscous and Photrexa are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking (CXL) for the treatment of progressive keratoconus. Avedro’s Photrexa Viscous, Photrexa and the KXL System represent a first-in-class therapeutic treatment for this sight-threatening indication, according to a news release from the company.
“This approval marks a tremendous milestone for the treatment of progressive keratoconus,” said Brian Roberts, chief operating and financial officer for Avedro, in the news release. “We’re excited to provide ophthalmologists in the United States with these tools to treat this orphan disease. We thank the FDA for their diligent efforts as we worked towards approval. We plan to begin taking orders for the KXL System immediately, and plan to begin shipping our Photrexa products in the next few months as we ramp up our drug manufacturing.”
Keratoconus is the most common corneal dystrophy in the US, affecting approximately one in every 2,000 Americans or approximately 170,000 people in the United States. This progressive thinning and weakening can result in significant visual loss and may lead to corneal transplants.
“This FDA approval has been highly anticipated by the keratoconus community,” said Mary Prudden, executive director for the National Keratoconus Foundation. “[CXL] provides patients a much-needed option to treat this debilitating disease. Patients suffering from progressive keratoconus can now receive a therapeutic treatment that has been rigorously tested and approved.”
“I applaud Avedro’s efforts to make this clinically important treatment available to US patients,” said Peter Hersh, MD, of The Cornea and Laser Eye Institute–CLEI Center for Keratoconus, and the clinical study medical monitor. Dr. Hersh continued, “In the studies, treated eyes showed improvement in Kmax at 12 months, while in untreated eyes Kmax continued to worsen. The Photrexa formulations and the KXL system represent an invaluable new treatment option for corneal surgeons in the treatment of keratoconus patients.”
Rajesh Rajpal, MD, a member of the AOC editorial board and CMO for Avedro added, “Avedro and I look forward to working with US ophthalmologists to raise awareness of our new FDA-approved treatment for progressive keratoconus.
The Photrexa formulations and the KXL System are expected to be available for qualifying patients through their ophthalmologists before the end of this year.
Blockbuster Allergan-Pfizer Merger Called Off
Pfizer and Allergan will not follow through on their planned $160 billion merger. The decision comes after the US Treasury Department unveiled a series of new steps to curb tax inversions. Pfizer has agreed to pay Allergan $150 million for the reimbursement of expenses associated with the transaction. The move came 2 days after the US Treasury Department introduced new rules to reduce the benefits of corporate tax inversions. The new rules will make it harder for companies to move their tax addresses out of the United States and then shift profits to low-tax countries. This maneuver is known as “earnings stripping.”
Although the US government did not mention Pfizer or Allergan by name in its announcement, the pending merger between the two companies represented the largest such deal. In November, the two companies agreed to merge in a $160 billion deal in which Pfizer would have its global operational headquarters in New York but its tax address in Ireland. The merger was scheduled to close in the second half of 2016.
Included in the US Treasury Department rules is the call to limit a company’s ability to participate in inversion transactions if it has undertaken one within the past 36 months. Allergan, under its previous name of Actavis, has been involved in several mergers in that time frame, including a $5 billion takeover of Warner Chilcott, a $25 billion purchase of Forest Laboratories, and the $66 billion merger with Actavis, in which the Allergan name was adopted.
Treasury Secretary Jack Lew called on Congress to pass short-term anti-inversion legislation and a broader revamp of the US business tax system. He made similar pleas in September 2014 and November 2015.
Allergan CEO Brent Saunders told CNBC that the US government had targeted his company’s failed deal with Pfizer. “It really looked like they did a very fine job of constructing a rule here—a temporary rule—to stop this deal, and obviously it was successful.”
Mr. Saunders specifically mentioned the provision in the rules that imposes a 3-year limit on foreign companies’ “bulking up” on US assets to avoid ownership requirements for a later inversions deal. He said that ban in particular was designed to block the Pfizer-Allergan deal. He also said that Allergan had been blindsided by the Treasury’s announcement.
“For the rules to be changed after the game has started to be played is a bit un-American, but that’s the situation we’re in,” Mr. Saunders said. “We built this deal around the law, the regulations, all the notices that were put out by the Treasury and it was a highly legal construct. We followed the rules that Congress had set for companies looking to move to foreign domicile.”
USC Roski Eye Institute Researchers Publish Largest Eye Study Among Chinese Americans
The University of Southern California (USC) Roski Eye Institute researchers and clinicians published the results of the National Eye Institute-funded Chinese American Eye Study (CHES), the largest ophthalmology study among those with Chinese ancestry living in the United States. The findings, published in JAMA Ophthalmology,1 point to critical interventions in the prevention and treatment of blinding eye diseases, such as age-related macular degeneration (AMD)and diabetic retinopathy (DR), among Chinese Americans.
Key findings of the CHES point to a higher percentage (85%) of neovascular or wet AMD than geographic atrophy or dry AMD (15%). This is almost the opposite of what has been found in whites or other ethnic groups, who typically have the same percentage of AMD types or a higher prevalence of dry AMD. The study also found that the prevalence of AMD is higher among Chinese Americans than the Chinese population living in urban/rural China, suggesting the influence of environmental or behavioral factors should be considered. According to the National Eye Institute (NEI), part of the National Institutes of Health (NIH), AMD is the leading cause of vision loss in the United States, affecting more than 2 million Americans.
The other substantial finding in the study is that participants with diabetes (17.4%) were three times more likely than those without the disease to have significant visual impairment. This increase was found in the Chinese American study participants with type 2 diabetes who had cataracts or macular edema resulting in visual impairments. While 41% of these Chinese American study participants had DR, this is a lower percentage than has been reported among Chinese people living in rural China (46%) and Latinos living in Los Angeles (48%). Chinese Americans were found to have a lower reported rate of DR than Chinese residing in rural northern China, likely a result of the former’s better access to diabetes screening and treatment.
Asian Americans are the fastest growing racial group in the United States, and Chinese Americans are the largest segment of this population, according to the latest US Census. Rohit Varma, MD, MPH, interim dean of the Keck School of Medicine of USC and director of the USC Roski Eye Institute, was the study’s principal investigator and is one of the world’s leading experts on population-based eye disease.
“This study sounds a clarion call for all eye care providers to be aware of the prevalence of wet AMD in those of Chinese ancestry and to provide the available treatments such as injections and laser therapies,” said Dr. Varma. “And while not as prevalent as we see in the Latino community, we also need to be aware of addressing those Chinese Americans with diabetes to prevent DR and the onset of significant visual impairment.”
Dr. Varma added that the treatments for wet AMD are aimed at blocking the growth of new abnormal blood vessels in the eye and are widely available as opposed to the lack of therapeutic options for dry AMD, a diagnosis that is typically treated through health lifestyle changes.
“The study gives us unprecedented insights into the burden of eye disorders among this fast growing racial group in the United States. The findings will help inform preventive screening strategies and guide health care resource planning,” said Maryann Redford, DDS, MPH, a program director for Collaborative Clinical Research at NEI.
The CHES involved more than 4,500 Chinese Americans aged 50 or older living in Monterey Park, California. Almost all (98%) of the study participants were first-generation immigrants. The participants underwent comprehensive eye examinations and interviews to assess risk factors for AMD and DR, including lifestyle factors such as smoking and daily diet. Photographs of the inside of the eyes were taken to also detect signs of these eye diseases.
Dr. Varma is the principal investigator of many major NIH-funded studies, including the Los Angeles Latino Eye Study (LALES), Multi-Ethnic Pediatric Eye Diseases Study (MEPEDS), African-American Eye Disease Study (AFEDS), and CHES. Additional findings from the CHES analyzing cataracts, glaucoma and other visual impairments are forthcoming. The USC Roski Eye Institute is ranked in the top 2 of the nation’s top grant recipients from the NEI and has achieved more than $32 million in annual grant funding.
1. Varma R, Choudhury F, Chen S. Prevalence of age-related macular degeneration in Chinese American adults: The Chinese American Eye Study [published online April 7, 2016]. JAMA Ophthalmol. 2016. doi: 10.1001/jamaophthalmol.2016.0588
Teleophthalmology May Expand Coverage in Emergency Eye Care
A new study shows that teleophthalmology may play a role in reducing coverage gaps in emergency department eye care, particularly in rural areas. The results of the study were published online in JAMA Ophthalmology.1
Researchers from the Veterans Affairs Palo Alto Health Care System in California conducted a study to evaluate the current state of ophthalmologist availability for California emergency departments and the potential benefit of teleophthalmology consultation for these departments. Surveys were remotely administered to 187 of the 254 emergency departments throughout California from June 30 to September 23, 2014. The researchers surveyed nurse managers (n = 187) and physicians (n = 121) from each emergency department to evaluate current availability of ophthalmologists for in-hospital consultation, as well as the clinicians’ perception of how teleophthalmology consultation would affect patients’ care in their departments.
Of the emergency departments surveyed, emergency ophthalmology coverage was available in less than half of the rural facilities (18 of 37; 48.6%) compared with about three-quarters (112 of 150; 74.7%) of nonrural facilities. Although most departments had at least a single ophthalmologist on staff, about half (48.6%) of the rural facilities lacked readily available access to an ophthalmologist and found it difficult to arrange timely evaluation by an ophthalmologist.
The researchers said the results of the study highlight the existence of a coverage gap for emergency eye care, particularly among rural facilities, and demonstrate clinicians’ high interest in, and the perceived value of the use of remote teleophthalmology consultation. Overall, the study suggests that teleophthalmology could play a role in mitigating coverage gaps in emergency ophthalmic care.
1. Wedekind L, Sainani K, Pershing S. Supply and perceived demand for teleophthalmology in triage and consultations in California emergency departments [published online March 24, 2016]. JAMA Ophthalmol. doi:10.1001/jamaophthalmol.2016.0316
J&J Vision Focuses Advocacy Efforts to Defend Regulation of the CL Industry
Johnson & Johnson Vision Care announced its renewed and continued commitment to advocate in support of the doctor-patient relationship and against legislation that threatens to undermine patient health and deregulate the industry, according to a news release. To further these focused advocacy efforts, the company has discontinued its Unilateral Pricing Policy and is replacing it with new programs to ensure broad access and support the needs of patients, doctors, and customers.
“The patient comes first,” said Millicent Knight OD, vice president of professional affairs, Johnson & Johnson Vision Care, in the news release. “We believe that it is in the best interest of the patient to see an eye doctor on a regular basis, and we will continue to advocate state by state to protect that relationship. Johnson & Johnson Vision Care has a long history of education and advocacy on the issues that matter most to our patients, doctors and customers, and we’re more active than ever before across the country working for the future of patient eye and overall health.”
Proponents of deregulation advocate for online prescribing of contact lenses and extending contact lens prescription expiration limits. We strongly believe that the safe and appropriate use of contact lenses must be firmly grounded in a legislative and regulatory environment that prioritizes and recognizes the vital role of eye care providers in ensuring patients’ health and safety. And, opposing these efforts requires our undivided attention. n