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Up Front | May 2016



Avedro has received approval from the US FDA for Photrexa Viscous, Photrexa, and the KXL System, according to a company news release. Photrexa Viscous and Photrexa are photoenhancers indicated for use with the KXL System in CXL for the treatment of progressive keratoconus.

“This FDA approval has been highly anticipated by the keratoconus community,” said Mary Prudden, Executive Director for the National Keratoconus Foundation, in the news release. “[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.”

The approval was based on Avedro’s New Drug Application submission, which encompasses data from three prospective, randomized, parallel-group, open-label, placebo-controlled, 12-month trials conducted in the United States to determine the safety and effectiveness of Photrexa Viscous and Photrexa when used for performing CXL in eyes with progressive keratoconus. These studies included study 1, which enrolled 58 patients with progressive keratoconus, and study 2, which enrolled 147 patients with progressive keratoconus. In each study, patients had one eye designated as the study eye and were randomly assigned to receive one of two study treatments (CXL or sham) in their study eye.

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IOL Exchange for a Trifocal Lens Implant

Crosslinked eyes showed increasing improvement in maximum keratometry (Kmax) from month 3 through month 12. Patients with progressive keratoconus had an average Kmax reduction of 1.40 D in study 1 and 1.70 D in study 2 at month 12 in the crosslinked eyes, whereas untreated eyes had an average increase of 0.50 D in study 1 and 0.60 D in study 2; the difference (95% CI) between the crosslinked and untreated groups in the mean change from baseline Kmax was -1.90 D in study 1 and -2.30 D in study 2.

In clinical studies, the most common ocular adverse reactions in any crosslinked eye were corneal opacity, punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.

Avedro plans to begin taking orders for the KXL System immediately and shipping the Photrexa products in the United States in the next few months, the news release said.

Visunex Medical Systems Receives CE Mark for PanoCam LT

Visunex Medical Systems has received the CE Mark for the PanoCam LT Wide-field Imaging System, according to a company news release.

The PanoCam LT is a compact, wireless imaging system that is designed to detect a number of external, anterior, and posterior segment vision disorders in premature and newborn babies. It can also be used for general ophthalmic imaging and eye disease inspection in children up to 6 years old.

Although vision screening is not currently standard of care in most neonatal centers, clinical data suggest that vision disorders may affect between 10% and 20% of all newborns, the news release said. The news release also said that early research conducted in Asia, Brazil, and the United States suggests that one in 70 children may have some form of vision disorder.

Although many visual problems may be transient, a growing number of clinicians believe that screening newborns may provide early detection of vision disorders such as retinal hemorrhages, which may be a precursor to amblyopia.

Glaukos’ iStent Trabecular Micro-Bypass Approved in Japan

The Japanese Ministry of Health, Labor and Welfare (MHLW) approved the iStent Trabecular Micro-Bypass (Glaukos) for use in conjunction with cataract surgery for reduction of IOP in adults diagnosed with mild to moderate open-angle glaucoma who are currently treated with ocular hypotensive medication, according to a company news release.

The iStent is the first ab interno microinvasive glaucoma surgery device approved for use in Japan, according to the company. The iStent is approved for sale in 27 countries worldwide. Made of surgical-grade nonferromagnetic titanium coated with heparin, the iStent is approximately 1 mm long and 0.33 mm wide; Glaukos believes it is the smallest device approved by either the FDA or MHLW.

In anticipation of the iStent approval, Glaukos recently established a direct commercial team and formed a wholly owned subsidiary in Japan. The company expects to officially launch the iStent in Japan later this year, once the iStent procedure is approved for reimbursement by the MHLW.

CXL FDA Approval: Responses From Around the Globe

FDA approval of Photrexa Viscous, Photrexa, and the KXL System (all Avedro) for CXL in patients with progressive keratoconus is a long-awaited step in offering many keratoconus and ectasia patients what has already been established as the standard of care globally.

I am pleased that our US colleagues can now enrich their armamentarium with CXL treatments. We look forward to new application ideas, their general feedback on the treatment, and their US clinical outcomes, which represent a significant body of scientific work that has been missing so far in the development of CXL.

— A. John Kanellopoulos, MD

This is great news, as now, finally, the standard of care for keratoconic patients is available in the United States, just as it has been available to patients in almost the rest of the world for years. The FDA approval will take away the need for US patients to travel long distances to sites with ongoing US clinical trials or to centers outside of their country for their treatment. Large-scale availability of CXL will end up making the treatment easier and more affordable and will provide patients with the opportunity for better follow-up closer to their homes.

Newer modifications such as contact lens–assisted CXL (CACXL) will extend the benefit of this treatment to an even greater population than standard CXL, for which the cutoff is at least 400 µm of minimum pachymetry after epithelial removal. CACXL can be performed successfully even in such patients when used judiciously and in the manner we have described.1

The FDA approval is indeed welcome news for doctors and patients alike.

— Soosan Jacob, MS, FRCS, DNB

1. Jacob S, Kumar DA, Agarwal A, Basu S, Sinha P, Agarwal A. Contact lens-assisted collagen cross-linking(CACXL): A new technique for cross-linking thin corneas. J Refract Surg. 2014;30(6):366-372.

With the FDA’s approval of CXL, this treatment method will hopefully reduce the number of corneal grafts being performed in the United States.

As we in Europe and other parts of the world have experienced, it is essential that clinicians who choose to implement CXL should be aware of the possible risks as well as industry-driven protocols and adaptations of the proven Dresden epi-off CXL protocol.

Keratoconus is the most dangerous and visually debilitating when it is in a progressive state. As literature shows, a progressive state is most commonly found in children and adolescents, particularly during puberty due to hormonal changes. It is essential that all children and adolescents have access to CXL treatment, as it is the only proven means to stop progression of keratoconus. Especially for individuals who may not be eligible candidates for corneal grafts, such as people with Down syndrome, CXL must be made affordable and accessible.

— Farhad Hafezi, MD, PhD

Rayner Opens the Ridley Innovation Centre

Rayner has opened the Ridley Innovation Centre, its new £20 million research and development, training, and production facility in Worthing, West Sussex, United Kingdom, according to a company news release.

The state-of-the-art, dedicated IOL production facility has the capability of manufacturing 3 million IOLs each year. With its new Enterprise Resource Planning (ERP) quality system, Rayner has the ability to trace every lens from source materials to a patient’s eye, the news release said. 

The Ridley Innovation Centre was also designed to enable training, education, and research. Featuring a wet lab, library, training facilities, and a museum on the history of the IOL, the facility enables Rayner to engage and partner surgeons and academics in product development, according to the company news release. 

“The opening of the Ridley Innovation Centre marks a significant step in what we plan to be an exciting, transformative period of growth ahead for Rayner,” Tim Clover, CEO of Rayner, said in the news release. “This major investment will treble our manufacturing capacity and put us in the best position to support the company’s ambitious business expansion.”

Beaver-Visitec Launches Visitec FLACS Cannula

Beaver-Visitec International (BVI) has launched the Visitec FLACS Cannula, a multifunctional cannula designed to improve surgical efficiency and optimize clinical outcomes during laser-assisted cataract surgery (LACS), according to a company news release.

The primary function of the Visitec FLACS Cannula is to ensure that all types of femtosecond incisions open smoothly, easily, and cleanly, the news release said. The cannula’s leading edge is blunt to safeguard against stretching, distortion, or creation of a second tunnel. Its thin design allows it to glide through and open femtosecond incisions with minimal effort, according to the company.

Additionally, the cannula can be used to inject OVD and/or other solutions into the eye, reducing the number of instrument passes into the eye and handoffs between surgeon and scrub nurse. As a multifunctional tool, use of the Visitec FLACS Cannula may decrease procedure time, potentially leading to increased room turnover and more efficient patient flow, according to BVI.

As a single-use device supplied in a manufacturer-sealed sterile package, the Visitec FLACS Cannula eliminates the risk of cross-contamination associated with reusable instruments and the need for sterilization protocols, the news release said.

Ora Names Simon Chandler to Lead Regulatory, Clinical Operations in Europe

Ora announced the addition of Simon Chandler, PhD, as Senior Director to lead regulatory and clinical operations for Europe, according to a company news release.

The company supports ophthalmology drug and device companies in Europe at all stages of product development with a broad range of services including preclinical research, regulatory strategy, clinical trial execution, data management, statistics, medical writing, manufacturing expertise, quality assurance, business development, and financing.

“Dr. Chandler is a key addition to Ora’s team and brings extensive experience in global clinical and regulatory operations, including overseeing approvals by the FDA, [the European Medicines Agency], and [the Pharmaceuticals and Medical Devices Agency],” Stuart B. Abelson, President and CEO of Ora, said in the news release. “His current experience in gene therapy is highly relevant given the potential of this new therapeutic modality to address unmet patient needs.”

Dr. Chandler has more than 15 years of ophthalmic industry experience across Europe and the United States, focusing on retina and anterior segment indications. He has led successful development teams in anti-infective, anti-allergic, glaucoma, and refractive surgery drugs.

Vitamin C Cuts Cataract Risk by One-Third, Lifestyle May Outweigh Genetics

The consumption of vitamin C may reduce the risk for cataract progression by one-third over 10 years, according to a study in Ophthalmology.1 The research also shows for the first time that diet and lifestyle may play a greater role than genetic factors in cataract development and severity.

Researchers at King’s College London conducted a prospective cohort study to determine the heritability of nuclear cataract progression and to explore prospectively the effect of dietary micronutrients on the progression of nuclear cataract. Cross-sectional nuclear cataract and dietary measurements were available for 2,054 white female twins from the TwinsUK cohort. Follow-up cataract measurements were available for 324 of the twins (151 monozygotic and 173 dizygotic twins).

Nuclear cataract was measured using a quantitative measure of nuclear density obtained from digital Scheimpflug images. Dietary data were available from the European Prospective Investigation into Cancer and Nutrition (EPIC) study’s food frequency questionnaires. Heritability was modeled using maximum likelihood structural equation twin modeling. Association between nuclear cataract change and micronutrients was investigated using linear and multinomial regression analysis. The mean interval between baseline and follow-up examination was 9.4 years.

The best-fitting model estimated that the heritability of nuclear cataract progression was 35% (95% CI, 13–54), and individual environmental factors explained the remaining 65% (95% CI, 46–87) of variance. Dietary vitamin C was protective against both nuclear cataract at baseline and nuclear cataract progression (β = -.0002, P = .01; and β = -.001, P = .03, respectively), whereas manganese and intake of micronutrient supplements were protective against nuclear cataract at baseline only (β = -.009, P = .03; and β = -.03, P = .01, respectively).

“Genetic factors explained 35% of the variation in progression of nuclear cataract over a 10-year period,” the study authors concluded. “Environmental factors accounted for the remaining variance, and, in particular, dietary vitamin C protected against cataract progression assessed approximately 10 years after baseline.”

1. Yonova-Doing E, Forkin ZA, Hysi PG, et al. Genetic and dietary factors influencing the progression of nuclear cataract [published online ahead of print March 23, 2016]. Ophthalmology. doi:10.1016/j.ophtha.2016.01.036.

Nearly 40% of Earliest Preemies Have Eye Problems at 6 Years

Nearly 40% of extremely preterm infants have some ophthalmic abnormality by 6.5 years of age, compared with about 6% of their term-born peers, according to a study in JAMA Ophthalmology.1

Kerstin M. Hellgren, MD, PhD, of Astrid Lindgren Children’s Hospital in Stockholm, Sweden, and colleagues conducted a study to investigate the ophthalmic outcomes of a national cohort of extremely preterm children (<27 weeks gestational age) at 6.5 years of age and to evaluate the impact of prematurity and retinopathy of prematurity (ROP). All surviving extremely preterm children born in Sweden between April 1, 2004, and March 31, 2007, were included and compared with a matched term control group as part of a prospective national follow-up study. Visual acuity, refraction in cycloplegia, and manifest strabismus were evaluated and compared with gestational age at birth and with treatment-requiring ROP.

A total of 486 patients were included in the study cohort. The mean gestational age was 25 weeks, and 45.7% were girls. At a median age of 6.6 years, 89.3% of eligible extremely preterm children were assessed and compared with 300 control group children. In the extremely preterm group, 2.1% were blind, 4.8% were visually impaired according to World Health Organization criteria, and 8.8% were visually impaired according to the study criteria. Strabismus was found in 17.4% and refractive errors in 29.7% of the extremely preterm children compared with 0% and 5.9%, respectively, of the control children (P < .001).

Overall, at 6.5 years of age, 37.9% of the extremely preterm children had some ophthalmic abnormality compared with 6.2% of the matched control group. When treatment-requiring ROP was adjusted for, no significant association between gestational age and visual impairment could be detected. For refractive errors, the association with gestational age remained after adjustment for treatment-requiring ROP.

“Treatment-requiring ROP was a stronger impact factor than gestational age on visual impairment and strabismus, but not on refractive errors as a whole,” the study authors concluded. “In modern neonatal intensive care settings, ophthalmologic problems continue to account for a high proportion of long-term sequelae of prematurity.”

1. Hellgren KM, Tornqvist K, Jakobsson PG, et al. Ophthalmologic outcome of extremely preterm infants at 6.5 years of age; Extremely Preterm Infants in Sweden Study (PRESS) [published online ahead of print March 24, 2016]. JAMA Ophthalmology. doi:10.1001/jamaophthalmol.2016.0391.

– Compiled by Steve Daily, Executive Editor, News; and Callan Navitsky, Senior Editor



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