At Press Time

Kentucky ODs to Perform YAG, SLT, ALT

PAC contributions seen as factor in new legislation.

By Jerry Helzner, Senior Editor

■ A bill that greatly expands the scope of practice of Kentucky optometrists breezed through the state legislature by wide margins and was swiftly signed into law by Gov. Steve Beshear in late February. Kentucky ODs can now perform a number of laser procedures previously only done by ophthalmologists, including YAG capsulotomy following cataract surgery and glaucoma treatments such as SLT and ALT and peripheral iridotomy.

The state's ODs will also be able to administer additional medications, including those that may be developed using new drug-delivery technologies. They can also lance chalazia using subdermal anesthetic. However, they cannot perform retina laser procedures, LASIK or PRK and they cannot administer general anesthesia.

One possibly troubling aspect of the Kentucky legislation is that, beyond specific exclusions noted in the bill, it is open-ended in the sense that it gives wide powers to the state Board of Optometric Examiners to determine the future scope of practice for optometrists.

The bill was strongly opposed by the Kentucky Medical Association and the Kentucky Academy of Eye Physicians on the grounds that ODs do not have the medical training to perform surgical procedures permitted under this legislation.

However, aggressive political activity may have played a role in the bill's speedy passage. Members of the Kentucky Optometric Association and their political action committee (PAC) gave more than $400,000 in political donations to legislators and Gov. Beshear in the past two years. The Louisville Courier-Journal newspaper reported that the optometric PAC also hired 18 lobbyists to take their case to lawmakers.

“(The legislation) attempts to dupe Kentuckians into believing optometrists are qualified to perform surgery on their eyes,” said Gordon Tobin, MD, president of the Kentucky Medical Association. “Political contributions shouldn't determine the quality of care Kentucky patients receive.”

The president of the American Academy of Ophthalmology, Richard L. Abbott, MD, also released a statement warning about what he called a “dangerous law.” He asked Kentucky legislators and the governor to take another look at the potential impact of the legislation “before it's too late.”

In signing the bill into law, Gov. Beshear noted that the legislation would provide greater and more convenient access to eye care in a state that is largely rural and underserved by ophthalmologists. More than half of the state's 120 counties do not have an ophthalmology practice with an office within the county. Optometric practices are located in 106 of the state's counties.

Earlier, lawmakers had rejected amendments that would have required ODs to undergo additional training before being certified to perform the surgical procedures allowed by the legislation.

Scope-of-practice battles have been heating up recently. In both Kentucky and California, optometric organizations have pushed legislation by claiming that rural populations do not have adequate access to ophthalmologists and, more specifically, that ODs can effectively perform certain basic glaucoma treatments.

Ista Sets Ambitious Sales and Profit Goals

Drug company sees $500 million in sales by 2015.

■ Ista Pharmaceuticals, which reported its first-ever profitable year in 2010, has served notice that it intends to soon join the first rank of companies specializing in ophthalmic drugs.

Among the goals set by the publicly traded company are achieving solid profitability this year, reporting earnings of $1 a share in 2013, obtaining five new drug approvals over the next five years and recording approximately $500 million in overall sales by 2015.

In 2010, Ista achieved sales of $156.5 million, which represented a 42% increase over 2009 revenue. Excluding one special non-cash charge, the company earned five cents a share for the full year. Results were driven largely by the strong performance of the topical NSAID Xibrom and its recently launched once-daily successor, Bromday. The two drugs accounted for about two-thirds of Ista's total 2010 sales. The introduction of Bepreve for allergic conjunctivitis accounted for an additional $15.7 million in revenue, while the glaucoma drug Istalol and the spreading agent Vitrase made up the balance of sales.

Ista now expects that 2011 net sales will increase to a range of $175 million to $190 million, with R&D expenses slotted at about 20% of sales. The company expects to report full-year earnings in a range of 11 to 18 cents a share and end the year with at least $90 million in cash.

“In 2011, we plan to gain market share with Bromday and Bepreve and we will announce initial results from key clinical trials for lower-concentration Bromday, Remura for dry eye and bepotastine nasal spray for allergic rhinitis,” said Vicente Anido, Jr., PhD, president and CEO of Ista. “Longer-range, our corporate targets are to deliver $1.00 EPS by 2013, attain five new product approvals over the next five years and achieve approximately $500 million in annual revenues by 2015.”

New Pricing, Upgrades for ORange Device

WaveTec offers unlimited use and drops per-procedure fees.

■ As the technology available for performing cataract surgery continues to grow more sophisticated, ophthalmologists have been balancing the need for better outcomes with the costs of bringing these advanced technologies into their practices.

In an indication that cost-effectiveness still weighs heavily on the decision to purchase advanced technology, WaveTec Vision is now offering unlimited use of its ground-breaking ORange intraoperative wavefront aberrometer in lieu of the per-procedure fees that it previously charged.

Moving away from a per-use cost basis, practices will now be charged a flat rate of $3,000 per month for unlimited use of the Orange device. Cost of the equipment is approximately $30,000, including first year's service contract; subsequent annual service contracts are priced at $3,000.

“We're thrilled that we can contribute a vital tool that is even more efficient yet readily available to the ophthalmic community,” said Tom Frinzi, WaveTec CEO. “By making it easier for surgeons to both purchase and perform ORange custom cataract surgery, we are able to assist in delivering optimal refractive outcomes to patients.”

Additionally, WaveTec's v2.6 software for ORange includes more than 20 new functions, with special focus on accuracy updates and data sharing. Improvements to the post-refractive IOL power calculation algorithm and a warning to the user when a measurement is not consistent with the preoperative biometry of the patient are some of the new features.

“With ORange, cataract surgeons can now validate their lens power calculations and manage astigmatism during surgery so they can precisely predict and customize how their patients will see following the procedure,” said Mr. Frinzi.

WaveTec says its technology has been clinically proven to increase accuracy and improve refractive outcomes: 73% of procedures are within 0.5 D of intended target, versus 58% with traditional cataract surgery using standard method biometry.

Research Digest New & Noteworthy Journal Articles

Compiled by Andrew E. Mathis, PhD, Medical Editor

► Combination therapy for NVG. A study from Japan appearing in the March 2011 issue of the Journal of Glaucoma evaluates the use in neovascular glaucoma (NVG) of intravitreal bevacizumab in combination with trabeculectomy and mitomycin C (MMC) vs. trabeculectomy and MMC alone. Fifty-seven eyes from 50 patients who had undergone trabeculectomy with MMC were retrospectively studied after all had been retreated, 33 with the same procedure and 24 with the addition of bevacizumab.

The intravitreal injections significantly reduced postoperative hyphemia. IOPs were also lower in the bevacizumab group seven and 10 days postop. However, surgical outcomes over the long term were essentially equal. The authors conclude that bevacizumab may be a useful adjunct in patients susceptible to postop hyphemia.

► Reducing injection pain. To determine how best to reduce intravitreal injection pain, retinal physicians at the Lahey Clinic in Peabody, Mass., submitted 24 patients to injections of four types of topical anesthetics (proparacaine, tetracaine, lidocaine pledget and subconjunctival lidocaine) and asked them to rank each shot on a 10-point scale. The results appear in the March 2011 issue of Retina.

None of the mean combined pain scores were higher than 4.4 out of 10. Proparacaine drops provided the best comfort in the patients studied, ranked best both in terms of pain when receiving the anesthetic and in mean combined pain. The authors recommend topical anesthetic in intravitreal injections.

► Aqueous dynamics. Doctors from the University of Nebraska Medical Center in Omaha conducted a study of 30 healthy volunteers, measuring IOP, aqueous flow, central corneal thickness, blood pressure and other variables to further their understanding of aqueous-humor dynamics. Reporting their findings in the March 2011 issue of Archives of Ophthalmology, they found that the aqueous undergoes significant changes at night, with IOP decreasing, along with aqueous flow, outflow facility and uveoscleral out-flow as measured by pneumatonometry.

Interestingly, mean central corneal thickness was greater at night despite mean IOP being lower, which is contrary to earlier findings.

A “Solution” To Improve Cataract Surgery

Omeros drug maintains mydriasis and reduces pain.

By Jerry Helzner, Senior Editor

■ Omeros Corporation has reported positive data from a phase 2b clinical trial evaluating OMS302 in patients undergoing cataract surgery. OMS302, added to standard irrigation solution used during ophthalmic procedures, is said to maintain intraoperative pupil dilation and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery.

In this 221-patient phase 2b clinical study, subjects treated with OMS302 demonstrated statistically significant and clinically meaningful maintenance of mydriasis throughout the cataract procedure. If mydriasis is not maintained, the risk of injuring structures within the eye increases and the required operating time is often prolonged. Of equal clinical relevance, OMS302 also significantly decreased pain in the early postop period and reduced the frequency of complaints of moderate and severe pain (2.5 times more complaints in the vehicle-treated patients). The drug product was safe and well tolerated in this study.

“These data are compelling and could represent a major advance for lens replacement procedures, including cataract surgery and refractive lens exchange,” said Alan Crandall, MD, director of glaucoma and cataract at the University of Utah. “OMS302 has the ability to facilitate the ease of the procedure while improving patient outcomes and safety.”

“Maintenance of mydriasis is critical to performing lens exchange safely and proficiently,” said Mark Rosenblatt, MD, PhD, associate professor of ophthalmology at Weill Cornell Medical College. In addition to the mydriatic benefit, the pain reduction reported by OMS302-treated patients is clinically important, he says. “Because OMS302 is administered through the irrigation solution currently used during lens exchange, the drug product fits readily into the workflow of the operating room and does not require a change in the surgeon's routine procedure.”

“We are pleased that OMS302 demonstrated statistically significant and clinically relevant benefits in this full-factorial phase 2b study,” said Gregory Demopulos, MD, chairman and chief executive officer of Omeros. “Each component of the drug product showed clear efficacy. Given the strength and consistency of these clinical data, we have begun preparations for a pivotal phase 3 program.” In this multicenter, randomized, double-blind, vehicle-controlled clinical trial, patients were randomized into one of four parallel treatment groups.

The first arm (n=55) received OMS302, the second arm (n=55) received only the mydriatic agent in OMS302, the third arm (n=54) received only the anti-inflammatory agent in OMS302 and the fourth arm (n=57) received standard irrigation solution without drug.

The co-primary endpoints of the study included maintenance of mydriasis and reduction of postoperative ocular pain. Patients in the OMS302 group demonstrated statistically significant maintenance of mydriasis over both the OMS302-anti-inflammatory and vehicle-treated groups. Similarly, the OMS302-treated group demonstrated a statistically significant reduction in pain compared with both the OMS302-mydriatic and vehicle-treated groups, demonstrating that each component of OMS302 contributed to the efficacy of the product. OMS302 was safe and well tolerated in this study. The complete phase 2b data set will be presented and published at a later date.OM