According to a recent report, prescription drug costs rose by 13.6% in 2015, which would lead to a doubling in price of pharmaceuticals over about a decade. However, I think what we often fail to recognize is the actual cost to bring a drug to market. In one study for a random selection of 106 drugs, the average cost per drug was over $2.5 billion whereas it was just over $800 million in year 2000 dollars (http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study). As we know, while not pharmaceuticals, contact lenses are FDA regulated medical devices that also bear substantial costs in terms of research, development and the regulatory process, so it is important to keep this in mind relative to new developments in contact lenses that improve our patients’ lives.
Jason J. Nichols, OD, MPH, PhD
Georgia Enacts Law Requiring In-Person Eye Exam for CL/Spectacle Prescription
The state of Georgia’s new law, HB775, which ensures a person can only receive a glasses or contact lens prescription after they have had an in-person eye exam with an optometrist or ophthalmologist, will take effect on July 1, 2016. The law was supported by the Georgia Optometric Association.
In our April 10, 2016 issue of Contact Lenses Today we reported on American Optometric Association (AOA) urging the Food and Drug Administration (FDA) to take legal action against an online vision test being marketed by Opternative, Inc. without the type of testing and pre-market approvals frequently required of new medical device technology. The Opternative test produces a prescription for eyeglasses or contact lenses without any examination of the patient by an eye care professional and without taking into account the patient's overall medical condition.
NovaBay Appoints Zavodnick to its
Board of Directors
NovaBay Pharmaceuticals, Inc. announces the appointment of Todd Zavodnick to its Board of Directors. Zavodnick brings extensive senior management and commercial experience in the medical technology and pharmaceutical industries, including serving in a senior capacity at the global ophthalmology company Alcon Laboratories. Zavodnick will serve on the Audit and Nominating and Corporate Governance committees.
NovaBay also announces the primary closing of a private placement for a total of 4,079,058 shares of Company common stock and warrants. The closing includes the purchase of 2,039,530 shares of common stock at an aggregate subscription price of $7.791 million to nine accredited investors, including Mr. Sieczkarek and the Company’s two largest stockholders, Jian Ping Fu and Pioneer Pharma (Singapore) Pte. Ltd. The private placement was designed to close in two tranches, with the closing of the second tranche for $4 million scheduled to occur on July 31, 2016. The Company believes that when fully completed, this financing, along with the exercise of related warrants, will provide NovaBay with the necessary funds to reach positive cash flow from operations without the need for additional financing.
The American Optometric Foundation (AOF) announces that the 2016 Jill and George Mertz Fellowship is awarded to Dr. Pauline Kang, an optometry graduate and faculty member of the School of Optometry and Vision Science, University of New South Wales, Sydney. Dr. Kang is planning to carry out her Mertz Fellowship at the State University of New York College of Optometry to conduct novel research exploring temporal integration of visual signals deriving from peripheral retinal defocus. The AOF will honor Dr. Kang during the annual AOF Celebration Luncheon at Academy 2016 Anaheim, on November 12th.
In September 2002, the optometric community experienced the sudden loss of a valued colleague and friend, George Mertz. His legacy exemplified a firm commitment toward the advancement of patient care through education and research. At the time of his passing George was President of the AOF. His mission was focused solely on education and research funding as a basis of for improved eye and vision care. After George's passing, George's wife Jill spearheaded and also chaired a move to establish the George W. Mertz Scholarship Fund. In 2007, Jill Mertz passed away. As a tribute to George and in keeping with Jill’s wishes; her family estate made a substantial gift which now goes to support the biennial $30,000 award in their name.
Non-verbal cues are often helpful in assessing patient satisfaction with their current vision correction modality. Corneal topography image of 19 year-old male Computer Science college student reveals satisfaction of orthokeratology lenses that correct his myopia of OD -5.00 and OS -5.50. While wearing nighttime topography-based OK lenses, myopia has not changed. Since shortly after starting OK in 2011, he has maintained uncorrected vision of 20/20 in each eye with same base curves.
We thank Dr. Sweeney for this image and welcome photo submissions from our other readers! It is easy to submit a photo for consideration for publishing in Contact Lenses Today. Simply visit http://www.cltoday.com/upload/upload.aspx to upload your image. Please include a detailed explanation of the photo and your full name, degree or title, and city/state/country.
Just When You Thought You Had It Down...Approval of Corneal Cross Linking Is Just Step One
As most of us are aware of, the FDA recently approved corneal cross linking in the United States. The approval was given to the Avedro system and is for the epithelium on technique. Although we have been waiting quite some time for this important approval, it is merely a first step in the management of progressive keratoconus. Outside of the United States more advanced technologies are already being evaluated. A recently published study looked at the outcomes from simultaneous topography-guided photorefractive keratectomy and accelerated corneal cross-linking for the management of keratoconus. The purpose was to study the evolution of visual and refractive outcomes through the first year after simultaneous topography-guided photorefractive keratectomy (t-PRK) and corneal collagen cross-linking (CXL) in keratoconus. This retrospective case series included 85 eyes of 66 patients with a mean age of 26.3 ± 5.7 years, which underwent simultaneous t-PRK with accelerated CXL. Patients were examined for uncorrected distance visual acuity and corrected distance visual acuity (CDVA), flat and steep keratometry readings, and manifest refraction spherical equivalent at 1, 3, 6, and 12 months. The results at 12 months found that all study parameters demonstrated a statistically significant improvement. Although 90.6% of eyes gained 1 or more lines of CDVA, no eyes lost any lines of CDVA. In all, 37.6% of the eyes demonstrated an improvement of 4 or more lines of CDVA with a maximum improvement of 11 lines of CDVA in 1 eye. The authors concluded that simultaneous t-PRK with accelerated CXL improved the spherocylindrical refraction and visual function of keratoconus eyes, and the outcomes were stable through 12 months of follow-up. Future studies with longer follow-up and larger data set are necessary to validate the results of the current study and evaluate the long-term safety and efficacy.
The paradigm of management of patients with keratoconus is changing at exponential rates. Now that we have proven and approved methods to halt progression of the disease we must consider early detection as an imperative. Cross linking is intended to stop disease progression while other technologies such as topography guided PRK, corneal ring segments, conductive keratoplasty and others are intended to reduce severity of the disease in terms of visual impact. Organizations such as the International Keratoconus Academy of Eye Care Professionals (www.keratoconusacademy.com ) are dedicated to advancing knowledge and information regarding this disease.
Sakla H, Altroudi W, Munoz G, Sakla Y. Simultaneous Topography-Guided Photorefractive Keratectomy and Accelerated Corneal Collagen Cross-Linking for Keratoconus. Cornea. 2016 Apr 27. [Epub ahead of print).
OCULAR SURFACE UPDATE Katherine M. Mastrota, MS, OD, FAAO
FDA Regulates E-Cigarettes
Just a week or two ago, we discussed the media campaign targeted at cigarette smoking. The negative effects of cigarette smoking on the ocular surface are multifold and well-documented.1 Nicotine delivery, dependency and adverse effects however, most agree to extend to electronic cigarettes otherwise known as e-cigarettes or vape.
After years of debate about the health risks of electronic cigarettes, the Food and Drug Administration issued sweeping new rules that for the first time extend federal regulatory authority to e-cigarettes, banning their sale to anyone under 18 and requiring that adults under the age of 26 show a photo identification to buy them.
E-cigarettes were introduced about a decade ago as devices that deliver nicotine without the harmful tar and chemicals that cause cancer. They have since grown into a multibillion-dollar business, with nine million American adults using them, and while most health experts agree that they are less harmful than cigarettes, little is known about their long-term effects, including those on the ocular surface. When the solution ("e-liquid") contains nicotine, the main adverse effects are those of nicotine. Bronchial disorders, neuropsychiatric disorders and ocular irritation have been reported with inhaled propylene glycol (the nicotine delivery base). The effects of propylene glycol and glycerol, when heated and inhaled over long periods, are not known. The addictive effect is difficult to determine.2
The new FDA rules regarding vape, which take effect in 90 days, subject producers to federal regulation for the first time, requiring them to register with the FDA and provide it with a detailed account of their products’ ingredients and their manufacturing processes. Producers will also have to apply to the FDA for permission to sell their products. That includes vape shops that mix their own e-cigarette liquid. The rules did not include specific bans on flavors in e-cigarettes. Antismoking activists had been pressing the agency to prohibit flavors in all tobacco products, arguing that they appeal to young people.3 I am interested (and hopeful) in seeing the change this new regulation has on the ubiquitous availability of these products in smoke shops, vape shops, kiosks, drug stores, supermarkets, newsstands, cards shops and just about everywhere else.
Altered Bulbar Conjunctival Microcirculation in Response to Contact Lens Wear
This study was conducted to determine blood flow velocities and corresponding vessel diameters to characterize the response of the bulbar conjunctival microvasculature to contact lens wear.
A functional slit lamp biomicroscope (FSLB), an adapted traditional slit lamp, was used to image the temporal bulbar conjunctiva of 22 healthy subjects before and after 6 hours of contact lens wear. All of the measurable venules on the conjunctiva were processed to yield vessel diameters and blood flow velocities.
The average blood flow velocity increased from 0.51±0.20 to 0.65±0.22 mm/sec (P<0.001) after 6 hours of lens wear. The blood flow velocity distribution showed a velocity increase that correlated with the vessel diameter increase from the baseline (r=0.826, P<0.05). This pattern maintained a similar trend after 6 hours of lens wear (r=0.925, P<0.05), and increased velocities were found across all of the vessel diameter ranges (P<0.001).
The authors concluded that blood flow velocity increases across all of the vessel diameter ranges in response to contact lens wear. Functional slit lamp biomicroscope is capable of characterizing the bulbar microvascular response to contact lens wear.
Chen W, Xu Z, Jiang H, Zhou J, Wang L, Wang J. Altered Bulbar Conjunctival Microcirculation in Response to Contact Lens Wear. Eye Contact Lens. 2016 Apr 13. [Epub ahead of print]