Quick Hits

Zeiss SMILE procedure gets FDA approval

New refractive surgery option offers flapless alternative to LASIK.

By Robert Stoneback, Associate Editor

Zeiss’ new laser vision correction procedure, ReLEx SMILE, has now been approved for the U.S., after five years of use internationally.

In the SMILE (small-incision lenticule extraction) procedure, a thin disc-shaped lenticule is cut within the corneal stroma. The lenticule is subsequently removed through a small opening incision on the superficial cornea, foregoing the need to create a corneal flap for refractive correction.

The SMILE procedure is performed with the Zeiss VisuMax femtosecond laser.

According to Zeiss, the side-cut created for SMILE is 2 to 4 mm, making it 80% smaller than the approximately 20-mm side-cut created for Femto-LASIK. In addition, Zeiss lists a 30% smaller cap incision area for SMIILE, compared with femto-LASIK.

Clinical trials

From clinical trials, it was learned that SMILE provides “a very reliable, accurate treatment for patients with myopia,” which is comparable to LASIK, according to John A. Vukich, MD. Dr. Vukich serves as associate clinical professor at the University of Wisconsin-Madison Medical School, and is an investigator for Zeiss.

The clinical trial examined patients with a range of -1 D to -10 D of myopia, Dr. Vukich says.

“The real bottom line is that the quality of vision, and the reproducibility and the accuracy and the safety of this treatment are excellent, in fact so good that the FDA didn’t feel that they had to take it to panel, that they could approve it based on the study outcomes submitted,” Dr. Vukich says.

While using a femtosecond laser will take some adjustment for doctors who are strictly used to excimer lasers, it’s “certainly well within the skillset of any ocular surgeon.”

Flapless surgery

The idea of LASIK-like accuracy without a flap was very powerful to patients, according to Vance Thompson, MD. Dr. Thompson, of Vance Thompson Vision in Sioux Falls, S.D., and assistant professor at the University of South Dakota School of Medicine, also served as an investigator for Zeiss during SMILE’s clinical trial. His patients found vision results to be equal in both LASIK and SMILE procedures.

For patients who want a custom technology that addresses high-order aberrations, PRK or LASIK may still be their preferred method, he says. Those without such aberrations now have the option of the above two or SMILE.

While clinical data have not backed this up yet, Dr. Thompson notes that computer modeling has shown that SMILE leaves the cornea more biomechanically stable.

Also, with fewer anterior corneal nerves cut during SMILE, patients with dry eye may be less impacted by their ailment and experience less foreign-body sensation.

Working with the whole practice

For Zeiss, it’s important to understand what a patient’s lifestyle is and what care they are looking for, says Jim Mazzo, Zeiss’ Global President, Ophthalmic Devices. Proper patient identification is important to Zeiss, which is why it is committed to working with the entire practice, not just physicians, to integrate SMILE, he continues.

“We’ll utilize every opportunity where our great practitioners are,” he says. This will primarily be done through in-office training, but training symposia will be used as well.

No significant modifications were made to the SMILE procedure to bring it to America, according to Mr. Mazzo. The main change was the creation of a US-specific version of the VisuMax software, which is a common request for the approval process.

The SMILE procedure “will help reinvigorate the (laser vision correction) market,” says Mr. Mazzo. He also wanted to point out that SMILE is “not anti-LASIK, it’s pro-refractive procedures,” because it’s meant to grow the market and is “the next evolution” for refractive technologies.

Mr. Mazzo expressed gratitude at the FDA’s quick approval of SMILE. Zeiss’ plan over the next three to four months is to expand its clinical support and technical service team and work with clinical investigators who have access to the procedure’s technology; from there, Zeiss will implement a broader offering to US refractive specialists. OM

Giving sight to the blind with Argus II

The Argus II bypasses cells affected by retinitis pigmentosa to stimulate the remaining retina.

By Robert Stoneback, Associate Editor

After Anthony Andreottola was diagnosed with retinitis pigmentosa (RP) 40 years ago, he never dreamed he’d have a victory against the disorder that gradually robbed him of sight.

Then last fall, he underwent surgery to use the Argus II retinal prosthesis.

The Arugs II, created by Second Sight, consists of: an epiretinal prosthesis, which Second Sight refers to as an implant, a pair of eyeglasses that house a video camera, and a hip-worn video processing unit.

The video camera records images and sends them to the portable video processor, which is connected to the glasses via cable. The data are transmitted wirelessly to the retinal implant, which emits electrical pulses into the retina. Since retinitis pigmentosa damages the retina’s photoreceptors, the Argus II bypasses these and sends the signals directly to the retina’s remaining cells, and then to the brain. These signals are “seen” as “patterns of light” by the patient.

Anthony Andreottola

“A distant memory of sight”

The Argus II is designed specifically to work with people suffering from RP, who have little to no light perception. The patients “only have a distant memory of what sight is like,” says Jim Handa, MD, Robert Bond Welch professor of ophthalmology at Johns Hopkins’ Wilmer Eye Institute.

Dr. Handa was one of several ophthalmologists who participated in a five-year study, from 2006 to 2011, that implanted and monitored the Argus II in 30 RP patients, all of whom were aged 40 to 70. The results of that study were published by the journal Ophthalmology in July, and stated that 24 of the patients remained implanted with the Argus II. Those patients are still being monitored today, says Dr. Handa. The study noted that patients “performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks.”

For the subjects, turning on the device for the first time was “sheer excitement.”

“Patients are jazzed just about seeing light, because it’s something they haven’t done for a long time.”

A first win against RP

Mr. Andreottola, who works as a mental health therapist in Boston, describes looking at people with the Argus II as “herky-jerky” flashes of colorless light. It reminded him of the sensation of being at a nightclub with a strobe light on, where you would occasionally glimpse movement and shapes.

“It’s not perfect, but I have more vision now than I did before,” he says. Previously only able to perceive light, he can now walk down the sidewalk without running into people or bushes, can more accurately find doors and determine how fast a car is traveling.

The Argus II “is the first time when it comes to RP that I ever had anything positive happen.”

“I haven’t given up”

Dr. Handa implanted three of the subjects with the Argus II during the study, among them Elias “Louie” Konstantopoulos, of Glen Burnie, Md.

Mr. Konstantopoulos, a former electrician, was diagnosed with RP in 1981 and began treatments at Johns Hopkins in 1982. He stopped working full-time in 1993.

He had the Argus II chip implanted in his eye in 2009, and became accustomed to it “the next day.”

“I’ve had no problems whatsoever,” and can’t even feel the chip on his eye, he says.

The Argus II is “a big help” with his day-to-day chores, he says. “I’m still doing those things … I haven’t given up.”

Pricing & coding

Second Sight has established “centers for excellence” where surgeons can be trained in how to implant the Argus II. After installation, a patient’s postoperative care is pretty routine, Dr. Handa says. A greater emphasis is placed on rehabilitation and occupational therapy, so patients can learn to interpret the light patterns they are seeing.

The Argus II is currently identified by Category III CPT code 0100T, according to Suzanne Corcoran, executive vice president of Corcoran Consulting Group. As a Category III code, there is no set allowable for the surgeon; there is a facility fee for hospitals of $95,000, which includes the device itself. Ms. Corcoran says she would not expect to see the procedure performed in an ASC since it requires general anesthesia, and that the procedure will be rare.

Dr. Handa has installed four Argus II devices since their U.S. rollout in 2013; he might have had the chance to put in more, but there have been complications with reimbursements.

While CMS currently allows $95,000 for the Argus procedure, the full cost of the device is $150,000. A proposed 2017 Medicare reimbursement would increase reimbursement up to $150,000, plus the necessary surgical cost.¹

Speaking from his own experience, Dr. Handa said that many prospective Argus II patients in his area had been denied completely through their insurance or Medicare. OM

REFERENCES

Trial: Roclatan more effective than Rhopressa, latanoprost alone

Rhopressa + latanoprost combined lowered IOP more than its separate components.

By Robert Stoneback, Associate Editor

Aerie Pharmaceuticals recently announced the successful, 90-day primary efficacy results of its Phase 3 trial for Roclatan, its IOP-lowering combination product for glaucoma.

Roclatan is a once-daily eye drop that combines Aerie’s Rhopressa eye drop and latanoprost. Results from the study, dubbed “Mercury 1,” found that IOP was 1 to 3 mmHg lower at all measured time points for patients taking Roclatan, when compared with patients in the study arms using either latanoprost or Rhopressa. Roclatan also reduced mean diurnal IOPs to 16 mmHg or lower in 61% of patients, according to Aerie.

The yearlong study, which began in September 2015, examined 238 people using the combination Roclatan medication, 244 using Rhopressa and 236 using latanoprost. Mercury 1 was designed to give a predefined look at data at three months, with data for the full year to be released once the study is closed out, a spokesperson said.

IOP levels were measured at 8 a.m., 10 a.m. and 4 p.m. at week two, week six and day 90.

By day 90, 88% of subjects on Roclatan had their IOP lowered by 20% or more, compared with 78% on latanoprost and 56% using Rhopressa. At the highest end of that spectrum, 35% of Roclatan subjects had their IOP lowered by 40% or more, compared with 9% of latanoprost subjects and 7% of those on Rhopressa.

The main adverse event associated with Roclatan was conjunctival hyperemia, which was recorded in 52.9% of patients, according to Aerie. Of those instances, Aerie said 80% were considered mild hyperemia. Hyperemia severity did not increase with continued dosing, and the majority of it was sporadic, Aerie said.

During a conference call, Roclatan representatives said 10% of patients had hyperemia at every visit. They also noted that the instances of hyperemia were consistent with other methods of treating glaucoma, and that the results were not surprising.

There were no drug-related serious adverse events during the trial, according to Aerie.

Patients in the Roclatan arm also reported these adverse events: conjunctival hemorrhage (10.5%), eye pruritus (7.6%), increased lacrimation (5.9%) and corneal verticillata (5%).

Of those in the Roclatan arm, 19% reported instillation site pain.

The next step for Roclatan is a three-month study, titled, Mercury 2, which is expected to start in 2017. More information can be found at http://investors.aeriepharma.com/events.cfm. OM