SUBSPECIALTY NEWS
Vit-Buckle Society Promotes “Learning by Doing”
Rising stars of retina mark a decade of progress.
BY JERRY HELZNER, CONTRIBUTING EDITOR
■ Five high-achieving retina fellows got to talking at the 2006 Fellows Forum meeting and came to the conclusion that the various retina training programs each had their own approach to performing basic vitreoretinal surgeries. The fellows then came up with the idea of sharing videos of these different techniques as a way to foster “best practices” among the next generation of retina specialists.
With that relatively small initiative, the Vit-Buckle Society (VBS) was formed. A decade later, it has grown into a 165-member organization with eagerly awaited regular meetings and primarily devoted to sharing the valuable practical knowledge that leads to excellence in performing vitreoretinal surgeries. Though VBS membership was initially limited to retina specialists who had been in practice for fewer than 10 years, it is now open to young and old alike, as long as the member had fellowship training in North America.
“We started with a rather humble idea and year-by-year the scope of the organization continued to grow,” says Tom Albini, MD, of Bascom Palmer, VBS cofounder and current president. “We had to open up membership because some of the more mature surgeons like Tim Murray and Harry Flynn (of Bascom Palmer) never missed a meeting.”
Though VBS has always had a surgical orientation, over the past decade it has expanded its realm to such additional areas as medical retina, forging relationships with industry, and early adoption of new technologies.
“We invite companies to make presentations on their latest products and procedures because the younger doctors tend to be the early adopters,” says Dr. Albini. “The companies also value our feedback as it helps them make improvements in these innovations.” For example, Dr. Albini is personally intrigued by the development of a new type of vitrectomy system with a hypersonic cutter and greatly increased cutting speed.
The VBS 2016 annual meeting in Miami Beach — attendance for the event has been increasing each year.
PHOTO COURTESY OF THE VIT-BUCKLE SOCIETY.
Dr. Albini points out that the retina community has always had a strong support system with such organizations as ASRS, the Macula Society, the Retina Society, and the AAO promoting clinical progress and advocacy. However, VBS is now filling an important role of its own.
“At the other organizations’ meetings, you’re going to hear mainly from doctors who conduct studies and serve as lead investigators,” he notes. “You’ll hear from them at our meetings as well but you’ll also hear from less-visible retina specialists who just operate a lot. This goes back to our focus on practical knowledge and sharing surgical techniques.”
At the most recent VBS annual meeting in Miami Beach, four retina specialists performed a live demonstration of vitrectomy using four different vitrectomy machines.
“These demonstrations created a tremendous amount of interest,” notes Dr. Albini. “And we always have a wet lab at our meetings. We’re now looking forward to our 2017 annual meeting in Las Vegas to see if we can come up with adding something new to the live demonstration that will showcase future technologies.”
Dr. Albini makes it clear that there is no generational divide in the retina community.
“We have nothing but admiration for the older generation of retina specialists,” he asserts. “These are the doctors who pushed the envelope — and they are continuing to push the envelope. They have served as great examples to us.”
Vision Loss Follows Uneventful Ocular Surgery
HORV linked to use of vancomycin.
■ On July 20, ASRS and ASCRS issued a joint “clinical alert” to make ophthalmologists aware of a recently identified condition called hemorrhagic occlusive retinal vasculitis (HORV) that can present from one day to a month following initially uneventful ocular surgery, primarily cataract removal.
The one common thread that has been so far identified with all cases of HORV is the use of intraocular vancomycin as an antibiotic prophylactic administered during the surgical procedure. Administration of the vancomycin was intracameral, intravitreal, or in an irrigating solution. Mean onset of sudden painless vision loss with moderate inflammation is eight days post-surgery. Immunology experts have hypothesized that HORV is possibly a hypersensitivity reaction rather than direct drug toxicity, but there is currently no way to test this hypothesis. No single formulation or manufacturer of vancomycin has been associated with HORV.
HORV was initially identified in 2014 in 11 eyes of six patients by researchers led by Andre Witkin, MD, an ophthalmologist at Tufts University Medical Center. Following that report, ASCRS and ASRS formed a blue-ribbon joint task force to study HORV. The organizations also asked their members to report any additional cases that they may have encountered in their practice. Although data collection is still ongoing, the task force believes the special alert is warranted because of the early findings and their potential impact on patient safety.
According to the ASRS/ASCRS task force, the clinical alert came after the request for new cases resulted in 16 additional reports of HORV, with 14 of them bilateral, for a total of 36 eyes. A range of treatments has thus far been tried in individual cases to combat HORV. According to the Tufts researchers, these have included topical and systemic corticosteroids, systemic antivirals, intravitreal antibiotics, and vitrectomy. Despite aggressive treatment, eight of the 11 eyes in the initial study had final outcomes of less than 20/100 and 22 of 36 eyes in the new reports had outcomes of 20/200 or less. In addition, eight of the 36 newly reported eyes had outcomes of no light perception. In an ironic twist, a few patients in the new group who presented with symptoms were given a second injection of vancomycin for presumed bacterial endophthalmitis. Five of the seven eyes given a second injection had an outcome of no light perception.
Intracameral vancomycin has been a popular drug for antibiotic prophylaxis in ocular surgery. Some high-volume practices have had no cases of HORV at all. The task force recommends considering switching to moxifloxacin or cefuroxime for antibiotic prophylaxis.
Any ophthalmologist who encounters a case that appears to be HORV should report it to the HORV registry at www.ascrs.org or www.asrs.org, where links to make the report are available.
IN BRIEF
■ Opposing views on supplements. Given the role of genetics and complement factors as being predictive of the risk for retinal disease, researchers are attempting to determine whether individuals should be genetically typed before taking eye health supplements. With conflicting studies presented and discussed at the recent ASRS meeting, no concrete evidence currently exists either in favor of or against the need for genetic typing.
Most observers agree that additional large-scale studies with clearly defined subgroups and meaningful criteria are needed to reach a conclusive determination.
■ Pfenex regains all rights to Lucentis biosimilar. Pfenex (San Diego) will go it alone, at least for now, after Pfizer opted out of a partnership to develop the Pfenex anti-VEGF drug PF582, a Lucentis (Genentech) biosimilar. Pfizer acted after undertaking a strategic review of its biosimilar portfolio. Biosimilars are equivalent, but not identical, versions of biologic drugs.
Pfenex, which said it will consider “strategic options” for the future development of PF582, announced that phase 1/2 safety and efficacy data from a 25-patient trial demonstrated “no meaningful differences” between PF582 and Lucentis.
In the United States, an inexpensive alternative to Lucentis already exists in the drug Avastin (Genentech), which is widely used in the treatment of a range of retinal diseases.
Opthea AMD Drug Shows Promise
Best results were in combination with Lucentis
■ Opthea Ltd. (Melbourne, Australia) said 16 of 19 patients who could be evaluated in a 20-patient, phase 1 clinical trial of its OPT-302 intravitreally administered anti-VEGF drug either gained or maintained vision at week 12. The small study encompassed four arms of five patients each, with three dose-escalation arms of OPT-302 with Lucentis and one arm consisting of OPT-302 monotherapy.
Best results were with four treatment-naïve patients who received an OPT-302/Lucentis combination and had a mean gain in visual acuity of 16.5 letters at week 12 along with a significant reduction in central subfield thickness. The study included treatment-naïve patients and those who had a prior suboptimal response to anti-VEGF monotherapy. No safety or tolerability issues were found during the course of the study.
OPT-302 offers a “pan-VEGF” approach to treatment, with the VEGF receptor3 (VEGFR3) “trap” drug inhibiting VEGF A, C, and D, while not active against the “good” VEGF B.
“Combination therapy with OPT-302 and standard of care Lucentis is both feasible and well tolerated in patients who are either naïve to treatment or resistant to prior therapy,” said Pravin Dugel, MD, managing partner of Retinal Consultants of Arizona. “Although the preliminary clinical activity data to date is based on a small number of patients, the promising gains in vision and anatomic improvements on SD-OCT that have been observed suggest that combined inhibition of VEGF-C/D and VEGF-A may lead to improved outcomes over Lucentis alone.”
OPT-302 now moves into a 30-patient phase 2a study that will further assess efficacy and durability.
IN BRIEF
■ Phase 2 studies for bispecific Roche drug. Roche/Genentech is now conducting two phase 2 clinical trials for its novel bispecific investigational drug RG7716, which is both a VEGF and an ANG-2 inhibitor.
The 271-patient AVENUE study targets wet AMD, while the newly commenced 150-patient BOULEVARD trial is for vision loss due to DME. AVENUE is a multi-armed study designed to compare different doses and regimens of RG7716 to monthly Lucentis over 36 weeks. BOULEVARD is designed to assess two different doses of RG7716 vs Lucentis at 28 weeks.
RG7716 demonstrated efficacy and durability signals in a small, ascending-dose phase 1 study of patients who had responded poorly to previous anti-VEGF treatments, as reported by lead investigator Pravin Dugel, MD, of Retinal Consultants of Arizona, at the recent ASRS meeting. Patients in the single dose study showed median BCVA gains of 7 letters 28 days after their last dose with significant reductions in central subfield thickness. In addition, Dr. Dugel also reported encouraging results in the multiple ascending dose study. He reported that the 6-mg dose improved vision in recalcitrant patients by a median of 7.5 letters with a median OCT CST reduction of 117 microns.
■ Anti-VEGF works best in clinical trials. In a large-scale study encompassing 750,000 US wet AMD patients who had received anti-VEGF therapy, real-world results failed to measure up to the vision gains achieved in highly structured clinical trials.
Researchers led by Thomas Ciulla, MD presented data at the recent ASRS meeting. They concluded that, in the real world, patients treated for at least a year on average received far fewer injections than individuals involved in clinical trials, who usually were treated monthly. In addition, the mostly elderly patients in real-world settings had difficulty keeping regular appointments, often needing caregivers to drive them to the doctor’s office. This is one factor that has led to overall undertreatment of patients, the researchers say.
The study data showed that those patients who had better baseline vision at the beginning of their anti-VEGF treatments tended to lose vision even while being treated. Patients who started anti-VEGF with poor vision tended to gain or maintain vision.
■ Topcon 3-D OCT-1 Maestro cleared by FDA. Topcon Medical Systems’ 3-D OCT-1 Maestro, which combines a high-resolution color non-mydriatic camera with spectral domain OCT technology, has been cleared by the FDA for sale in the United States. The Maestro also features a rotating touch panel and fully automated operation that encompasses alignment, focus, and capture.
A Possible Alternative to Povidone-Iodine?
A California retina specialist is using hypochlorous acid.
■ For the overwhelming majority of retinal physicians, the process of administering intravitreal injections begins with the application of povidone-iodine. However, a retina specialist in Sonoma County, CA, has been using hypochlorous acid in a 0.01% saline preparation from NovaBay (Avenova; Emeryville, CA).
Patrick Caskey, MD, of North Bay Vitreo-Retinal Consultants in Santa Rosa, says having a significant number of patients with contact sensitivity to povidone led him to consider using hypochlorous acid.
“We originally began using it to treat patients with blepharitis in whom we were concerned about administering injections. It worked much better and more quickly than topical antibiotics,” he explains. “Avenova is designed to replicate the chemical action that white blood cells use to kill bacteria; it has better bacterial coverage and works faster than povidone-iodine. Our encouraging experience with blepharitis patients led us to consider using it as an alternative to povidone-iodine.”
Dr. Caskey was very pleasantly surprised with the results. “It works like a charm,” he says. “We start blepharitis patients on it for about a week before injection. There’s been no irritation reported by these patients and the blepharitis has typically resolved by the time of the injection.”
Not only is there no irritation, but 0.01% hypochlorous acid is so safe that it can be sprayed directly on the eye, Dr. Caskey says. There is also no staining, he points out, for those patients concerned with cosmetic outcomes.
For the past three years, Dr. Caskey has been using only Avenova for his povidone-sensitive injection patients and a combination of one drop of povidone-iodine upon patient arrival followed by a drop of Avenova about two minutes before the injection in his povidone-tolerant patients.
In addition to the aforementioned advantages of avoiding povidone reactions and iodine staining of the skin, the key purpose of endophthalmitis prophylaxis has been served as well. Dr. Caskey says the practice has had one case of endophthalmitis over the last three years — a case of Staphylococcus epidermis — for an infection rate of approximately 0.00017%, which represents a slight improvement since he began using Avenova.
The only disadvantages that Dr. Caskey cites are economic, related not only to the price of Avenova (approximately $30 per 40-mL bottle) but also the lack of reimbursement from CMS. For those patients not limited by cost considerations, however, Avenova might afford an excellent alternative to povidone-iodine. RP
IN BRIEF
■ Luminate in vitreomacular adhesion: additional data. Researchers led by Baruch D. Kuppermann, MD, of the Gavin Herbert Eye Institute, University of California, Irvine, CA, set out to determine the effectiveness of the antiangiogenic and vitreolytic oligopeptide Luminate (Allegro Ophthalmics, San Juan Capistrano, CA) in patients with either symptomatic focal vitreomacular adhesion or vitreomacular traction. The researchers recently provided additional data to previously reported study highlights.
A total of 106 patients in the United States and Europe were randomized into four arms of the phase 2 study. Three of the arms received intravitreal Luminate (at doses of 2.0 mg, 2.5 mg, or 3.2 mg), while the fourth arm received placebo. The doses were administered monthly, up to a maximum of three.
In the highest-dose 3.2-mg group, 65% of the patients achieved release by day 90, compared with 21% in the 2.5-mg arm, 23% in the 2.0-mg arm, and 10% in the placebo group. In all of the groups, 48% of the releases occurred after a single injection, 32% following the second injection, and 20% following the third and final injection. The most common adverse events were conjunctival hyperemia and subconjunctival hemorrhage at the injection site. There were no reports of more serious adverse events.
The researchers concluded that Luminate met its primary endpoint of vitreomacular adhesion or vitreomacular traction release and was well tolerated by all of the dosing groups.
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