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Up Front | Aug 2015


CMS Soliciting Comments on Office-Based Cataract Surgery

The Centers for Medicare & Medicaid Services (CMS) is seeking public comment regarding the advisability of paying for cataract surgery in the office-based surgical suite. Whereas CMS cites potential advantages of performing cataract surgery—the highest-volume procedure performed on Medicare beneficiaries—in an office setting, several stakeholders have raised concerns regarding patients' safety and compliance.

In a small section of its 815-page proposed 2016 Medicare fee schedule regulation,1 CMS cites a number of perceived advantages to implementing an office-based policy, including advances in technology, convenience for patients, flexibility in scheduling surgery, and lower Medicare expenditures.

“Advancements in technology have significantly reduced operating time and improved both the safety of the procedure and patient outcomes,” a portion of the CMS Medicare fee schedule read. “We believe that it is now possible for cataract surgery to be furnished in an in-office surgical suite, especially for routine cases. Cataract surgery patients require a sterile surgical suite with certain equipment and supplies that we believe could be a part of a nonfacility-based setting that is properly constructed and maintained for appropriate infection prevention and control.”

Experts with an interest in keeping procedures in an ambulatory surgical center (ASC) setting, however, have raised concerns.

“While fair and equitable reimbursement of ASCs is always a concern (lest facilities will be unable to offer high-quality, affordable, and accessible eye surgery), we view patient health and safety as our first priority,” Michael A. Romansky, JD, vice president of corporate development and Washington counsel for the advocacy group Outpatient Ophthalmic Surgery Society (OOSS), said in a statement to CRST. “The growth in volume of cataract surgery and our exceptional outcomes and very low incidence of TASS [toxic anterior segment syndrome] and other complications are testaments to this ‘patient first' commitment. OOSS supports reasonable regulation of ASCs, and our centers meet and commonly exceed requirements established by Medicare, state health regulatory bodies, and facility accreditation agencies.”

Dr. Romansky said it is critical that patients' health and safety be considered before any incentives are provided for office-based surgery.

“We believe that CMS's request for information regarding appropriate payment for office surgery puts the cart before the horse,” he said. “Before providing incentives for surgeons to perform cataract surgery in their offices, the agency should work with the ophthalmology and ASC communities to examine whether surgery can be safely performed in the office setting, what specific patient health and safety standards should be applied, and what form of oversight is required.”

Robert Weinstock, MD, director of cataract and refractive surgery, Eye Institute of West Florida, Largo, Florida, and chief medical editor of CRST, said CMS's solicitation for feedback is an opportunity for surgeons to voice their opinions on the viability of office-based cataract surgery.

“It's clearly our responsibility to approach this subject from a patient-centric perspective,” Dr. Weinstock said in a statement to CRST. “Not long ago, cataract surgery was done in the hospital with a 3- to 7-day inpatient stay, and implants were considered experimental. We all know how quickly things have changed, and it would not surprise me if things continue to evolve. Regardless of the direction this goes, it's important for ophthalmologists to stay involved and help foster a viable model for a continued improvement in safety and visual outcomes for our patients.”

Comments may be submitted to CMS until September 8, 2015, either electronically at www.regulations.gov or through the mail at Centers for Medicare & Medicaid Services, Department of Health and Human Services, CMS 1612-P2, Attention: CMS-1631-P; P. O. Box 8013, Baltimore, MD 21244-8013.

1. Centers for Medicare & Medicaid Services (CMS), HHS. Medicare program; revisions to payment policies under the physician fee schedule and other revisions to part B for CY 2016. https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-16875.pdf. Pages 53-55. Published online July 15, 2015. Accessed July 20, 2015.

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The Victus Receives Clearance for Enhanced Patient Interface Kit

The Victus Femtosecond Laser Platform (Bausch + Lomb) has received 510(k) clearance from the FDA for an enhanced patient interface kit, according to a news release. The interface features a smaller-diameter suction clip. The modification reportedly allows easier opening and closing of the clip to help facilitate more efficient placement in patients with narrow fissures and smaller eye openings.

Additional features of the enhanced patient interface kit, which is intended to improve the performance of the suction ring as well as laser operation function, include a colored skirt on the suction clip to assist surgeons in achieving optimal centration to avoid tilt and optimize the inner working diameter of the suction ring. Multiple suction ports along the inside of the ring were incorporated to assist surgeons in obtaining optimal control of the eye throughout the Victus Femtosecond laser procedure. Also, an enhanced contoured handle give surgeons a comfortable grip and improved control of the suction clip, including an easy lock/unlock feature.

Earlier this year, the Victus received 510(k) clearance from the FDA for an advanced swept source optical coherence tomography imaging system and updated software that allows customized treatment planning for improved efficiency and patient flow during surgical procedures. The platform has additional CE Marks, including corneal incisions, penetrating keratoplasty, and the creation of intrastromal channel incisions for intracorneal ring segments.

Shire Acquires Foresight Biotherapeutics

Shire has acquired privately held Foresight Biotherapeutics for $300 million, according to a news release. With the acquisition, Shire gains the global rights to FST-100 (topical ophthalmic drops combining 0.6% povidone-iodine and 0.1% dexamethasone), a therapy in late-stage development for the treatment of infectious conjunctivitis. Shire will evaluate an appropriate regulatory filing strategy for additional markets outside the United States. If approved by regulatory agencies, FST-100 has the potential to become the first agent to treat both viral and bacterial conjunctivitis, the company said.

The phase 2 proof-of-concept efficacy and safety clinical trial program for FST-100 involved two studies in adenoviral conjunctivitis—one three-armed study and another two-armed pilot study. Although the two-armed study showed a trend toward efficacy, there were too few subjects testing positive for a viral presence for the study to deliver meaningful results, and the results were not statistically significant.

In the three-armed study, patients were randomized to receive FST-100, 0.6% povidone-iodine, or vehicle four times daily for 5 days. According to the company, patients treated with FST-100 showed a statistically significant improvement in rates of clinical cure and viral eradication versus vehicle at day 6 (30.6% vs 6.4%, P = .0033). In the same trial, there was a trend toward clinical significance for FST-100 versus 0.6% povidone-iodine (30.6% vs 18.0%, P = .1432). The most common treatment emergent adverse events were corneal infiltrates (19%), punctate keratitis (22.4%), and eyelid edema (12.1%).

The phase 2 clinical data formed the basis of a meeting with the FDA, in which Foresight Biotherapeutics discussed the path forward to conduct a phase 3 clinical development program for FST-100 as a potential treatment for adenoviral conjunctivitis. Upon close of the transaction, Shire will take responsibility for the final development and implementation for the phase 3 clinical program for FST-100, which will also include investigation for the treatment of bacterial conjunctivitis. Foresight Biotherapeutics conducted preclinical experiments evaluating the bacterial killing speed of FST-100 against pathogens that may cause bacterial conjunctivitis, and the resulting data reportedly support further exploration.

Allergan Sells Its Gobal Generics Business to Teva for $40.5 Billion

Teva Pharmaceutical announced that it has signed a definitive agreement with Allergan to acquire Allergan's generics business in a transaction valued at $40.5 billion, according to a company news release. Upon closing, Allergan will receive $33.75 billion in cash and shares of Teva valued at $6.75 billion, representing an estimated under 10% ownership stake in Teva, with the number of Teva shares determined based on Teva's volume-weighted average trading prices during the 15 days prior to the announcement and 5 days following the announcement. Teva believes the acquisition will be significantly accretive to nongenerally accepted accounting principles earnings per share, including expected double-digit nongenerally accepted accounting principles earnings per share accretion in 2016 and more than 20% accretion in year 2 and year 3 following the close of the transaction. The transaction was unanimously approved by the boards of directors of Teva and Allergan and is expected to close in the first quarter of 2016. n

“This transaction delivers on Teva's strategic objectives in both generics and specialty,” Erez Vigodman, president and CEO of Teva, said in the news release. “Through our acquisition of Allergan generics, we will establish a strong foundation for long-term, sustainable growth, anchored by leading generics capabilities and a world-class late-stage pipeline that will accelerate our ability to build an exceptional portfolio of products—both in generics and specialty as well as the intersection of the two. Our respective portfolios of generic medicines and applications are highly complementary, providing Teva with high-quality growth and earnings visibility, and the scale and resources to expand upon our specialty capabilities.”

In related news, Allergan has entered into a definitive agreement to acquire Naurex, a clinical-stage biopharmaceutical company developing transformative therapies for challenging disorders of the central nervous system, according to a company news release. Under the terms of the agreement, Allergan will acquire Naurex for a $560 million upfront payment net of cash acquired, $460 million of which is payable upon the closing of the acquisition and $100 million of which is payable by January 2016 (or upon the closing if the closing has not occurred by such time) as well as potential research and development success-based and sales-threshold milestone payments. The company says it remains committed to de-leveraging to below 3.5× debt-to-earnings before interest, taxes, depreciation, and amortization by the end of the first quarter of 2016.

BVI Launches I-Ring

BVI introduced the I-Ring Pupil Expander at this year's meeting of the American Society of Cataract and Refractive Surgery. According to the company, the device is a simple, safe, and innovative solution for the intraoperative expansion of a small pupil. Made of polyurethane to be gentle on intraocular tissue, the ring is designed to protect the corneal endothelium by remaining planar in the anterior chamber. The I-Ring has a fixed channel height to avoid compressing and pinching the iris during the device's insertion or removal. According to BVI, the ring completely engages the iris to provide a 6.3-mm working area, and the shape of the device's aperture helps to guide creation of the capsulorhexis. The I-Ring is designed for single-handed insertion, engagement, and removal—the last two steps requiring only a Sinskey hook. The learning curve for the device is reportedly minimal.

Valeant to Acquire Egyptian Pharmaceutical Company

Valeant Pharmaceuticals International has entered into a definitive agreement under which it will acquire Mercury (Cayman) Holdings, the holding company of Amoun Pharmaceutical, for consideration of approximately $800 million plus contingent payments, according to a company news release.

Amoun Pharmaceutical is the largest domestic company in the Egyptian pharmaceutical market and currently expects to reach 1.75 billion Egyptian pounds by 2015, with annual growth of approximately 20%. Amoun operates a manufacturing plant that is considered to be one of the largest and most up-to-date pharmaceutical facilities in Africa and the Middle East and has market-leading pharmaceutical brands in therapeutic areas such as antihypertensives, broad-spectrum antibiotics, and antidiarrheals, according to Valeant.  

Valeant intends for Amoun to serve as a platform for further expansion in the broader Middle East and North African pharmaceutical market and expects the transaction to close in the third quarter of 2015, subject to customary closing conditions.

First AMD Patient Receives the Argus II System

Second Sight Medical Products announced the first implantation and successful activation of the Argus II Retinal Prosthesis System in a patient with dry age-related macular degeneration (AMD).

The implant is part of a feasibility study that aims to evaluate the safety and utility of the Argus II System in individuals with late-stage dry AMD. The procedure was performed at the Manchester Royal Eye Hospital in the United Kingdom by Paulo Stanga, MD, a consultant ophthalmologist and vitreoretinal surgeon there and a professor of ophthalmology and retinal degeneration at The University of Manchester.

The device was activated approximately 2 weeks after implantation, and initial reports confirm that the patient is receiving some useful vision from the device, which is approved in the United States and Europe for individuals with retinitis pigmentosa and outer retinal degeneration, respectively.

The study includes patients 25 to 85 years of age with advanced dry AMD, some residual light perception, and a previous history of useful form vision. Study subjects will be observed for 3 years to evaluate the safety and utility of the Argus II system regarding visual function. Pending positive study results, the company plans to conduct a larger study to support market approvals.

The launch of this study is another step toward Second Sight's mission to enable blind people to achieve greater independence. Earlier this year, the company's first Orion I Visual Cortical Prostheses were implanted in animals to evaluate fit, form, stability, and biocompatibility. Human trials for the Orion I are planned to commence by the first quarter of 2017. If successful, the Orion I reportedly has the potential to address nearly all forms of blindness.

Sightpath Medical Reaches Milestone of 25,000 Mobile Laser Cataract Procedures

Sightpath Medical announced they have reached a milestone: participation in more than 25,000 laser cataract procedures since adding this technology to their mobile cataract offering in March 2013, according to a company news release. The service suite, called MoFe, includes a femtosecond laser, a certified laser engineer, certification coordination, ongoing clinical support, and access to Sightpath's customer resources for implementation assistance.

“We have been absolutely shocked at how positive the response has been,” Larry Patterson, MD, an ophthalmic surgeon with Eye Centers of Tennessee, said in the news release. “Our patient acceptance rate of the laser cataract procedure is almost double what it had been of the manual procedure. The beauty of partnering with Sightpath is that I'm able to offer laser to those who want it, standard to those who don't, and let the patient make the choice. I am not under any pressure to talk patients into a procedure they don't really want.”

EyeGate Signs Licensing Agreement with Valeant for Uveitis Treatment

Eyegate Pharmaceuticals has entered into an exclusive, worldwide licensing agreement with a subsidiary of Valeant Pharmaceuticals International, according to a news release. Under the terms of the agreement, EyeGate has granted Valeant exclusive worldwide commercial and manufacturing rights to its EyeGate II Delivery System and EGP-437 combination product (“Product”) for uveitis as well as a right of last negotiation to license the Product for other indications.

EGP-437, Eyegate's first and only product in clinical trials, incorporates a reformulated topically active corticosteroid, dexamethasone phosphate delivered into the ocular tissues through the company's proprietary EyeGate II Delivery System.

According to the news release, EyeGate will receive an upfront cash payment, development-based milestone payments related to the completion of development for the indication of anterior uveitis, and an approval-based milestone payment upon the FDA's approval of the Product. Additionally, the company will receive royalties based on net sales and additional milestone payments based on the achievement of certain cumulative sales milestones. Eyegate will be responsible for the development of and associated costs for the Product in the United States for the indication of anterior uveitis. Valeant has the right to develop the Product in the field outside of the United States and has agreed to fund 100% of the associated costs.

Inotek Announces Phase 3 Development Strategy for Trabodenoson

Inotek Pharmaceuticals announced the phase 3 development strategy of its lead glaucoma drug, trabodenoson, a first-in-class selective adenosine mimetic designed to restore the eye's natural pressure control mechanism, according to a company news release. Based on feedback from a recent end-of-phase 2 meeting with the FDA, Inotek is in the final preparatory stages to commence its first phase 3 trial to support a new drug application for trabodenoson. The company said it expects to begin the first phase 3 trial in the fourth quarter of this year.

The five-arm superiority trial will include three doses of trabodenoson. These doses were selected to optimize IOP lowering while maintaining the tolerability observed in phase 2 trials. The primary efficacy endpoint is the reduction of IOP, statistically superior compared to placebo. A comparator arm of timolol will be included for study validation but not for statistical comparison.

In phase 2 trials, trabodenoson demonstrated a dose-response for IOP lowering in eyes with ocular hypertension and primary open-angle glaucoma. After 14 days of treatment, both the 200- and 500-mg doses of trabodenoson demonstrated a statistically significant reduction (P < .05) in IOP relative to the matched placebo group. After 28 days of treatment, the 500-mg dose continued to demonstrate a statistically significant reduction in IOP relative to placebo, in the range of other glaucoma therapies. Across all trials, the efficacy of trabodenoson has reportedly remained consistent, with no waning effect observed, and the IOP reduction was consistent across different patient subpopulations. Trabodenoson has also been well tolerated with no serious adverse events. In patients with glaucoma or ocular hypertension, the rate of conjunctival hyperemia was not affected by trabodenoson treatment, according to Inotek. n

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