Quick Hits

Implanted IOP sensor successful in trial

It delivers pressure readings on demand.

Implandata Ophthalmic Products GmbH (Hanover, Germany) has successfully completed its ARGOS-01 pilot study for the first implantable, permanent IOP sensor. The micro sensor allows close monitoring of patients’ disease status and glaucoma therapy success, with IOP readings obtained on demand through a hand-held RFID device.

Through simple and more frequent measurements of IOP, the ophthalmologist has faster access to information on therapy response, enabling the doctor to adjust therapy immediately or when necessary, preventing further vision loss due to increased IOP. Patients can perform measurements by themselves at home and under normal life conditions, potentially leading to increased adherence to therapy regimens.

“This is a major technology milestone and clinical breakthrough,” says Robert N. Weinreb, MD, director of Shiley Eye Centers at the University San Diego and a consultant to Implandata. “Glaucoma clinicians and researchers from all over the world are eagerly awaiting applicable technologies to continuously measure real intraocular pressure. This will lead to more efficient management and improved therapy of glaucoma patients.”

In addition, Implandata believes its technology could represent the starting point to find answers to fundamental, currently unanswered questions, such as what specific pressure situations are responsible for progression of glaucoma and how therapeutic regimens can be adjusted accordingly.

Patients can obtain IOP readings on demand with a radio frequency device.

Within the ARGOS-01 study, six glaucoma patients were implanted with the micro sensor for IOP measurement at University Eye Clinic in Aachen, Germany. Over 12 months, the investigators monitored tolerance of the implant and functionality. They reported limited product-related issues, all of which a minor design optimization of the implant addressed.

Implandata says the sensor implants have delivered reliable measurements of intraocular pressure. Currently, Implandata is preparing its multi-centric ARGOS-02 study, which will include a larger number of patients.

Regeneron to begin two-drug trial for treatment of wet AMD

Anti-VEGF and anti-PDGF in a single injection.

The race for a next-generation therapy to combat wet AMD continues as Regeneron Pharmaceuticals has announced plans to soon launch a clinical trial combining two internally developed drugs in a single injection. This move represents an advance for Regeneron’s research efforts. No other company developing drugs to treat retinal disease has yet been able to begin a clinical trial combining two therapeutic agents in a single injection

In mid-January, Regeneron and Bayer HealthCare said they have agreed to move ahead with an innovative antibody to PDGFR-beta, or platelet derived growth factor receptor-beta, as a potential combination therapy with its approved drug Eylea (aflibercept) for the treatment of wet AMD.

Regeneron says preclinical data has suggested that combining PDGFR-beta blockade with vascular endothelial growth factor (VEGF) blockade by Eylea can provide advantages over inhibiting VEGF alone in the treatment of this disease. First human clinical studies are currently planned to begin in the next few months, Regeneron says.

“Given the multi-factorial nature of wet AMD, there is a potential for additional benefits to patients by addressing different pathways responsible for this devastating condition,” says Kemal Malik, MB, member of the Bayer HealthCare executive committee and head of global development for the company. “Inhibition of PDGF is one such pathway and we are looking forward to developing a potential combination therapy together with Regeneron.”

Adds George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories: “Bayer has been a great collaborator in the development and commercialization of Eylea outside the United States. We look forward to building on our relationship in ophthalmology with this potential next-generation product candidate which will combine Regeneron’s PDGFR-beta antibody and Eylea in a single intravitreal injection.”

Under the terms of the agreement, Bayer HealthCare will make an up-front payment of $25.5 million to Regeneron and will share global development costs for the program. Bayer HealthCare will have exclusive commercialization rights to the combination product outside the United States, where it will share profits from international sales equally with Regeneron. Within the United States, Regeneron has exclusive commercialization rights and will retain 100% of the profits from sales.

Hearing services can be a profit center

tips of the month

In recent years, many ophthalmology practices seeking to develop the self-pay percentage of their revenues have added hearing services to their patient offerings. Here, Peter J. Polack, MD, FACS, of Ocala Eye (Ocala, Fla.) explains the advantages of adding hearing services to your practice.

1. Hearing services are complementary to an eye-care practice. Because most ophthalmology practices serve a patient base weighted toward a senior population, these same seniors are also excellent candidates to have their hearing checked. It’s quite common to find hearing loss associated with eye disease, with many patients unaware they have a hearing deficit.

2. Patients trust their eye doctor. In a survey of patients that our practice conducted before we added hearing services, 80% of respondents said they would trust us to evaluate their hearing.

3. Hearing programs are relatively easy to initiate. We chose to affiliate with a leader in turnkey hearing programs for ophthalmic practices. This is because the company offered us pricing advantages on hearing aids and supplies, while also providing expert assistance in setting up our program. Your biggest decision will be hiring a qualified hearing professional to run the program. The hearing services company can provide a list of suitable candidates.

New federal standards allow faster claims payments

Electronic claims processing made simpler.

By René Luthe, Senior Associate Editor

With all the regulatory burdens weighing on medical practices this year, Robert Tennant, senior policy advisor at Medical Group Management Association, wants physicians to know the Affordable Care Act includes something to make their lives easier.

“Buried in the ACA section 1104, Administrative Simplification — it requires the government to develop new standards and what are called operating rules for many of the transactions that practices engage in with health plans.,” he notes.

These simplification opportunities for practices include EFT — electronic funds transfer — as well as electronic remittance advice, or ERA, the information the payer sends back to the practice regarding payment of individual claims. Health insurance companies now must offer both to practices in standard formats.

A streamlined process

Instead of the current practice of receiving reimbursement from payers in the form of a paper check in the mail, and then sometime later receiving a paper remittance advice for those claims, also through the mail, these two steps can be done electronically. While EFT gets a practice its reimbursements more quickly by depositing them directly into the practice’s bank account, ERA enables the practice to avoid the difficulties that often occur when the identification numbers associated with the remittance advice statement do not match the reimbursements, or payers bundle their payments and staff try to determine if the plan paid correctly.

“It’s a huge drain on practice resources,” says Mr. Tennant. “That will all change with ERA, in which the health plan has to send what is called a ‘trace number’ that matches the payment with the remittance.” If you have not implemented practice management system software capable of processing these automated transactions yet it would preclude your participation in ERA, but not, thankfully, EFT. “You can be totally paper, but for EFT, all you need is a bank account and you get those payments sent to you electronically,” Mr. Tennant explains.

A standardized EFT enrollment website is available (www.caqh.org) but as of now only a handful of payers are participating. Until more do, practices wanting to enroll in EFT or ERA should go to the websites of payers with whom they have contracts to do so.

ReSure Sealant gets FDA approval

For preventing wound leaks after cataract surgery.

Ocular Therapeutix (Bedford, Mass.) has received FDA approval to commercialize the ReSure Sealant in the United States, with an indication for prevention of postoperative fluid egress from incisions with a demonstrated wound leak following cataract surgery.

The ReSure Sealant is the first and only sealant that is FDA-approved for ophthalmic use.

The company said ReSure Sealant was evaluated in a prospective, controlled, randomized, multicenter clinical trial for prevention of fluid egress in clear corneal incisions against sutures, and demonstrated superiority over sutures by successfully preventing wound leaks in 95.9% of cases, compared to 65.9% of cases with sutures. The ReSure Sealant also demonstrated significantly fewer device-related adverse events than the control group — 1.6% vs. 30.6%, respectively.

“Eye surgeons have been waiting for an alternative to suture that is easy to apply, comfortable for the patient, and does not require removal following surgery,” says John Hovanesian, MD, of Harvard Eye Associates, Laguna Hills, Calif., and a principal investigator in the pivotal clinical trial. “Beyond those advantages, the ReSure Sealant has shown itself to be even more effective than suture in sealing corneal incisions against the real-world forces that can cause wound leaks after cataract surgery. I foresee this device becoming a staple in ophthalmic practices nationwide.”

ReSure Sealant is a patented polyethylene glycol-based (PEG) hydrogel applied as a liquid and gels on the surface of the eye in less than 20 seconds. Once the ReSure material gels, it remains localized over the incision to seal the wound and form a lubricious surface barrier.

The material is designed to stay on the incision in the immediate postoperative period when wounds are the most vulnerable to leakage, after which it gently sloughs off in the patient’s tears.