EyeWorld Weekly Update, June 29, 2018

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June 29, 2018
Volume 24 , Number 23

Novartis announces intention to spinoff Alcon

Novartis (Basel, Switzerland) announced its intention to spinoff Alcon, its eye care division, into a separately traded standalone company. The planned spinoff would enable Novartis and Alcon to focus fully on their respective growth strategies, the company said on its website. Completion of the transaction is subject to market conditions, tax rulings and opinions, final Board of Directors endorsement and shareholder approval in 2019. "We continue to execute our strategy to focus Novartis as a leading medicines company," said Vas Narasimhan, MD, Novartis CEO, on the company website. "Alcon has returned to a position of strength and it is time to give the business more flexibility to pursue its own growth strategy as the world's leading eye care devices company. We will work to ensure a smooth transition for Alcon and Novartis associates while preparing for the launch of RTH258 and building our leading ophthalmology pharmaceuticals business."

FDA approves iStent inject

The U.S. Food and Drug Administration (FDA) approved the iStent inject Trabecular Micro-Bypass System (Glaukos, San Clemente, California). The iStent inject is the company's next-generation trabecular micro-bypass technology. It is based on the same fluidic method of action as the first-generation iStent, according to a company press release. The iStent has been implanted in more than 400,000 eyes since its introduction in 2012. The approval by the FDA is based on the iStent inject U.S. IDE pivotal study, which was a prospective, randomized, multicenter trial with 41 investigational sites and 505 mild to moderate primary open angle glaucoma eyes randomized to receive the iStent inject in combination with cataract surgery (n=387) or cataract surgery only (n=118). In the study, the device achieved a statistically significant reduction in unmedicated diurnal IOP in patients having cataract surgery at 24 months. The iStent inject is already available in the European Union and other countries around the world.

Orphan drug status given by EMA to LBS-008 for treatment of Stargardt disease

The European Medicines Agency (EMA) has given the orphan drug designation to LBS-008 (Lin BioScience, San Diego), a first-in-class oral therapy to treat the inherited condition Stargardt disease. LBS-008 prevents the buildup of toxins in the eye that cause Stargardt disease and atrophic age-related macular degeneration. "Adding orphan designation in Europe to the recent orphan drug designation in the United States marks another important regulatory milestone in the development program for LBS-008," said Lin BioScience CEO Dr. Tom Lin in a company press release. "We look forward to receiving our interim Phase 1 clinical trial results later this year."

Positive opinion received for orphan drug designation from EMA for AAV-CNGA3

A positive opinion recommending orphan drug designation of AAV-CNGA3 (MeiraGTx Holdings, London, U.K.) to treat achromatopsia caused by CNGA3 gene mutations has been received from the European Medicine Agency (EMA). Achromatopsia is an inherited retinal disease. AAV-CNGA3 is an investigational gene therapy treatment designed to restore cone function; it is delivered to the cone receptors at the back of the eye via subretinal injection, according to a company press release.

STAAR Surgical announces resolution of FDA Warning Letter

STAAR Surgical (Monrovia, California) received a close-out letter from the FDA on June 19 that lifted a Warning Letter from May 2014 that addressed failures with procedures, documentation, and design controls. "The lifting of the Warning Letter is the result of a comprehensive mediation program that not only addressed the issues raised by the FDA in the 2014 Warning Letter, but included the assessment, remediation, and upgrade of all aspects of STAAR's quality of systems to assure compliance with Quality System Regulations," said STAAR president and CEO Caren Mason in a press release.

RESEARCH BRIEFS

  • The KAMRA small aperture intracorneal inlay (CorneaGen, Seattle) improved near vision both monocularly and binocularly in a prospective clinical trial. It was also safe, effective, and had only a minimal effect on distance visual acuity. As reported by John Vukich, MD, the study included 507 patients with emmetropic presbyopia with intracorneal implantation of the inlay in the non-dominant eye. Implanted eyes had 3.5 D of defocus range above 20/40, with 87.1% of 417 patients and 93.8% of 417 patients having 20/40 or better monocular and binocular uncorrected near visual acuity at 36 months, respectively. An uncorrected distance visual acuity of 20/25 or better was maintained in 93.1% of 145 of implanted eyes monocularly and in 100% of implanted eyes binocularly at 36 months. A loss of two or more lines of corrected distance visual acuity for 3 months or more at any time after surgery occurred in fewer than 1.5% of eyes. Forty-four inlays (8.7%) were removed from the full cohort over 3 years. Fewer than 1.0% of patients reported severe glare or halos postop. The study is published in the Journal of Cataract & Refractive Surgery.
  • Stress may be both a cause and consequence of vision loss, according to research from Bernhard Sabel and coresearchers in their article "Mental stress as consequence and cause of vision loss: The dawn of psychosomatic ophthalmology for preventive and personalized medicine." The researchers addressed the continuous mental stress caused by vision loss, including depression and social isolation. "While prolonged mental stress is clearly a consequence of vision loss, it may also aggravate the situation. In fact, continuous stress and elevated cortisol levels negatively impact the eye and brain due to autonomous nervous system imbalance and vascular dysregulation; hence stress may also be one of the major causes of visual system diseases such as glaucoma and optic neuropathy," the authors wrote. The causal role of stress for the development or progression of certain visual system disorders is not widely appreciated, the authors wrote. Stress reduction and relaxation techniques such as meditation, stress management training, and psychotherapy should be recommended in addition to traditional treatments for vision loss, according to the authors. They also think more clinical studies are needed to confirm the causal role of stress in different low vision diseases. The research appears in EPMA Journal.
  • A large proportion of keratoconjunctivitis is not associated with a detectable adenovirus, reported Cecilia Lee, MD, based on a large clinical cohort focused on determining host and pathogen factors predictive of outcomes in keratoconjunctivitis. Researchers conducted a retrospective analysis of clinical and molecular data from a randomized, controlled masked trial of auricloscene for keratoconjunctivitis (NVC-422, NovaBay Pharmaceuticals, Emeryville, California). The study included 500 participants from the U.S., Indian, Brazil, and Sri Lanka with a clinical diagnosis of keratoconjunctivitis and positive rapid test results for adenovirus. Among the participants, 78% showed evidence of adenovirus by polymerase chain reaction; for adenovirus-positive participants, adenovirus D species made up 63% of total cases and was the most common. However, four species and 21 types of adenovirus were detected. Adenovirus D was associated with more severe signs and symptoms. A high viral load at presentation and non-U.S. origin of participants were associated with a poorer clinical outcome. The study appears in Ophthalmology.
  • There may be an increased risk of late age-related macular degeneration (AMD) in association with 3-month or more use of anticholinergic drugs, reported Gauthier Aldebert, MD, and coauthors. Their multicenter case-control study focused on 200 cases with late AMD and 200 controls enrolled between July 2016 and June 2017. Exposure to at least 3 months of anticholinergic drugs was recorded during an interview. Multivariate logistic regression analysis adjusted for other factors, such as age, sex, smoking status, and a family history of AMD. Thirteen percent of study cases and 5% of controls were exposed to anticholinergic drugs throughout life for at least 3 months before AMD developed. The AMD risk increased with greater exposure to anticholinergic drugs. Further studies are needed to confirm the association the researchers concluded. The study is published in JAMA Ophthalmology.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, chief medical editor; Rosa Braga-Mele, MD, cataract editor; Clara Chan, MD, cornea editor; Nathan Radcliffe, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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