The FDA released several draft guidances today that it said it hopes will assist generic drug makers get their products through the development and approval process while keeping the agency’s Risk Evaluation and Mitigation Strategy, or REMS, safety controls in place.
“Bringing together multiple products under one REMS program can have real benefits for the health care system, including for providers. But, the generic drug maker has to negotiate with the brand firm to enter into a shared REMS programs before the generic drug can be approved. We know that (Read more...)
Author: Healio ophthalmology
AMA: Opioid prescriptions drop 22% nationally
Patrice A. Harris
A new report issued by the AMA revealed that opioid prescribing has decreased nationwide, while the use of state prescription drug monitoring programs, access to naloxone and the number of physicians trained to treat opioid use disorder have all increased, according to a press release.
“While this progress report shows physician leadership and action to help reverse the epidemic, such progress is tempered by the fact that every day, more than 115 people in the United States die from an opioid-related overdose,” Patrice A. Harris, MD, MA, (Read more...)
AMA: Opioid prescriptions drop 22% nationally
Patrice A. Harris
A new report issued by the AMA revealed that opioid prescribing has decreased nationwide, while the use of state prescription drug monitoring programs, access to naloxone and the number of physicians trained to treat opioid use disorder have all increased, according to a press release.
“While this progress report shows physician leadership and action to help reverse the epidemic, such progress is tempered by the fact that every day, more than 115 people in the United States die from an opioid-related overdose,” Patrice A. Harris, MD, MA, (Read more...)
Topline results reported in phase 2 trial of Clearside’s CLS-TA with Eylea in DME
A phase 2 clinical trial of suprachoroidal CLS-TA with Eylea met its primary endpoint of mean improvement in best corrected visual acuity in patients with diabetic macular edema, Clearside Biomedical announced in a press release.The multicenter, random…
Topline results reported in phase 2 trial of Clearside’s CLS-TA with Eylea in DME
A phase 2 clinical trial of suprachoroidal CLS-TA with Eylea met its primary endpoint of mean improvement in best corrected visual acuity in patients with diabetic macular edema, Clearside Biomedical announced in a press release.The multicenter, random…
Young woman presents with bilateral photophobia and corneal opacities
A 24-year-old woman presented to New England Eye Center upon referral from her outside ophthalmologist complaining of several years of light sensitivity, burning pain and blurred vision in both eyes.
The patient’s ocular symptoms first began in childhood with a foreign body sensation in both eyes. By her early teenage years, the foreign body sensation worsened and was associated with a sharp, shooting pain and light sensitivity. These symptoms had acutely worsened 3 months before presentation. The patient had multiple changes in her refractive error over the last few years (Read more...)
Taking a chance on Botox paid off for Allergan
Visionary. A word often used to describe prescient leaders, which fits Gavin Herbert Jr., founder of Allergan, perfectly. A friend of presidents, influential political operatives and leaders in the ophthalmic industry, he is still seeing the future at the sage age of 86, and he shows no signs of slowing down.
I met with Gavin in his office at Roger’s Gardens, his successful home and garden center in Newport Beach, California, on the day after my return from the American Society of Cataract and Refractive Surgery meeting. Surrounded by beautiful (Read more...)
Is your practice a ‘learning company’?
“In a learning organization, leaders are designers, stewards, and teachers. They are responsible for building organizations where people continually expand their capabilities to understand complexity, clarify vision, and improve shared mental models — that is, they are responsible for learning.” – Peter Senge
In America, an ophthalmologist is only allowed to practice after spending more than 50,000 hours in formal education and passing a few thousand quizzes, tests and board examinations. Interestingly, the same ophthalmologist often balks at the cost and downtime of
Do you envision ophthalmologists becoming too dependent on artificial intelligence?
Click here to view the Cover Story for this Point/Counter.A common reflex reaction to machine learning advances in medicine is concern that AI may one day replace physicians or that physicians become too dependent upon it, deteriorating their clinical …
Cataract outcomes: Getting the best results, now and in the near future
Patient expectations to be less dependent or free of spectacles have become increasingly important with premium IOLs. In this article, I will explain common methods of assessing patient outcomes, show the progress we have made in the last decade, how t…
Counseling our dry eye patients: How to enhance compliance with lifitegrast or cyclosporine
All of us use an algorithm that guides our dry eye treatment regimen. Mine is basically a combination of the TFOS DEWS II algorithm and the recommendations of the International Workshop on Meibomian Gland Dysfunction. At some point on our treatment lad…
AI may be an asset to ophthalmic surgeons
There are many definitions of artificial intelligence, but my favorite is: “The theory and development of computer systems able to perform tasks that normally would require human intelligence, such as visual perception, speech recognition, decision-making and translation between languages.”
The concept of AI first surfaced in 1956 in a symposium at Dartmouth College. In medicine, significant investments are being made by our largest corporations including IBM (Watson), Google and Microsoft, and many of these efforts are focused on ophthalmology. I have found that when significant
AI applications in ophthalmology achieve human expert-level performance
Artificial intelligence, deep learning and machine learning are being used by ophthalmologists to verify disease diagnoses, read images, perfect IOL calculations and improve surgical outcomes as these advanced techniques become more commonplace in the field.
Artificial intelligence, also called AI, spans a broad field. Machine learning is a subfield of AI, and deep learning is a subfield of machine learning, Aaron Y. Lee, MD, of UW Medicine, said. Most recent breakthroughs have been in the field of deep learning.
“These breakthroughs in computer vision have allowed near human performance
Nicox reports first quarter highlights
Nicox reported cash and cash equivalents of 36.3 million euros as of March 31 compared with 41.4 million euros at the end of 2017, according to a press release.
The company’s net revenue was 0.075 million euros in the first quarter of 2018, which was comprised entirely of royalty revenue from sales of Vyzulta (latanoprostene bunod ophthalmic solution 0.024%) through its partner Bausch + Lomb, after a deduction of royalty payments to Pfizer. Nicox recorded no revenue in the first quarter of 2017.
A new licensing agreement with Bausch + (Read more...)
FDA approves CustomFlex artificial iris
The FDA has approved a prosthetic device to replace a missing or damaged iris, the agency announced. Approval of the CustomFlex artificial iris was granted to HumanOptics AG.
“Today’s approval of the first artificial iris provides a novel method to treat iris defects that reduces sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia,” Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, said in (Read more...)
Patient candidates for SMILE: Punt or treat
by John F. Doane, MDWhenever a surgeon identifies whether a patient is the right candidate for a refractive procedure, he or she must ensure that the entry criteria by which the patient has been evaluated has successful results. The goal is to identify…
HPV vaccine does not increase risk for autoimmune disease in teen girls
The risk for autoimmune disease among teenage girls does not increase after they receive the quadrivalent HPV vaccine, according to findings published in the Canadian Medical Association Journal.“Despite demonstrated effectiveness in real-world setting…
HPV vaccine does not increase risk for autoimmune disease in teen girls
The risk for autoimmune disease among teenage girls does not increase after they receive the quadrivalent HPV vaccine, according to findings published in the Canadian Medical Association Journal.
“Despite demonstrated effectiveness in real-world settings, concerns continue to persist regarding the safety of the [quadrivalent human papillomavirus (HPV4)] vaccine,” Jeffrey Kwong, MD, MSc, a coauthor of the study and senior scientist at the Institute for Clinical Evaluative Sciences and Public Health Ontario, Toronto, said in a press release. “In light of these concerns, we
First patient treated in Salutaris brachytherapy device trial for AMD
The first patient has been treated in a clinical trial of an ophthalmic brachytherapy device for neovascular age-related macular degeneration, Salutaris Medical Devices announced in a press release.
Principal investigator Gregg Kokame, MD, successfully performed the procedure with the SMD-DA device on May 9 in Honolulu.
The prospective, single-arm, open-label study is evaluating the safety and tolerability of the SMD-DA system concomitant with an anti-VEGF treatment regimen in 20 patients; surgeon ease of use will also be determined.
“Our hope is to provide improved outcomes to the growing
EyeGate files Ocular Bandage Gel IDE supplement for punctate epitheliopathy
EyeGate Pharmaceuticals has filed a supplement to its investigational device exemption for punctate epitheliopathy using its Ocular Bandage Gel, according to a press release.
“The filing of this IDE supplement represents the next step for our OBG platform and shows EyeGate’s continued progress,” Stephen From, EyeGate president and CEO, said in the release. “We are hopeful that we will receive a positive response to this IDE supplement and will be able to move into the clinic in the second half of 2018.”
The IDE for the Ocular Bandage Gel was (Read more...)