U.S. surgeons anticipate new IOLs

Take home

With a wide array of IOL options available to their foreign colleagues, U.S. ophthalmologists eagerly await the approval and availability of additional lenses.

By Cheryl Guttman Krader; Reviewed by Malik Kahook, MD, Randall Olson, MD, and Mark Packer, MD

In 2014, U.S. cataract surgeons remained envious of the range of IOL options available to their foreign colleagues.

However, at the close of the AAO meeting in October, they were looking forward to the upcoming FDA Ophthalmic Devices Panel review of the AcrySof IQ ReSTOR Toric Multifocal IOL (Alcon Laboratories) and excited about the Tecnis Symfony Extended Range of Vision IOL (Abbott Medical Optics), which had just been released onto the European market and is being studied in an FDA trial.

Mark Packer, MD, referred to FDA panel review of the ReStor Toric IOL as the biggest IOL-related news of the year for U.S. surgeons. On Nov. 14, it was announced that the FDA’s Ophthalmic Devices Advisory Committee has recommended approval for AcrySof IQ ReSTOR Multifocal Toric Intraocular Lens (ReSTOR Toric IOL) for patients undergoing cataract eye surgery who are astigmatic and suffer from presbyopia.

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He anticipated an approval would not be announced until 2015. But when it comes, it will be a big deal, said Dr. Packer, who is in private practice, Boulder, CO, and clinical associate professor of ophthalmology, Oregon Health & Science University, Portland.

“To date, surgeons implanting multifocal IOLs have had to rely on corneal relaxing incisions or LASIK to address significant astigmatism. Approval of the Trulign toric accommodating IOL (Bausch + Lomb) in 2013 brought an option that certainly provides better intermediate and near vision than a monofocal toric IOL. The ReSTOR toric will be the first multifocal toric IOL in the US, and that is exciting,” he said.

Randall Olson, MD, noted that at the XXXII Congress of the ESCRS in September, there were a number of presentations reporting interesting results with a multitude of new approaches to presbyopia-correcting IOLs and continued excitement about the Rayner add-on lenses as more outcomes data were presented about that technology. However, he said that many of these technologies are unlikely to reach the U.S. market as the cost of running the regulatory juggernaut is limiting manufacturers’ interest in pursuing FDA approval.

“That is certainly a big concern for U.S. surgeons,” said Dr. Olson, professor and chairman, department of ophthalmology and visual sciences and chief executive officer, John A. Moran Eye Center, University of Utah, Salt Lake City.

Of the IOLs discussed at the ESCRS Congress, Dr. Olson and Dr. Packer concurred that the brand new Tecnis Symfony Extended Range of Vision IOL was the most interesting as it represents a new concept for addressing presbyopia that seems to overcome the limitations of multifocal IOLs.

The Tecnis Symfony combines two complimentary diffractive technologies.  The first uses a modification of the height and the profile of the diffractive echelette to elongate the focus, as compared to the diffractive echelletes in a multifocal that create two discrete foci. The second reduces chromatic aberration and boosts image quality.

Dr. Olson noted that the optical properties of the lens appear to have been tweaked just so such that the IOL delivers a very broad defocus curve with excellent vision, at least through the intermediate range, and without obvious loss of visual quality.

“We have known for a long time that it is possible to gain depth of focus by increasing negative asphericity, and by applying that property, recipients of the Light Adjustable Lens (Calhoun Vision) have achieved 20/20 at distance and J1 at near. However, the downside with any hyperaspheric IOL is that it can be pretty unforgiving in terms of tolerance to less than perfect positioning, and the optical quality drops off dramatically if the IOL is not well-centered,” said Dr. Olson.

“In physics you don’t gain something for nothing. Therefore, I remain skeptical that there is not more to the story with the Symfony IOL and I feel it is important to wait for more evidence. However, from what I’ve heard so far from respected and trusted surgeons, patients implanted with this IOL are seeing 20/20 at distance and intermediate with very usable, J2 or J3 near vision and are not experiencing any loss of contrast or perceptible problems with glare, halos or other dysphotopsias. So, it looks like they are having their cake and eating it too.”

Dr. Packer described the category of extended depth of focus lenses as an interesting hybrid as they are neither multifocals, accommodating, or pseudoaccommodating lenses.

He noted the idea of modifying chromatic aberration to improve image quality arose when researchers were developing the Tecnis multifocal IOL. In working with the aspheric multifocal optic to eliminate spherical aberration, they noticed that chromatic aberration could also be reduced by using a diffractive-like technology.

Dr. Packer also noted that studies in patients implanted with the Tecnis Symfony IOL show that the defocus curve is relatively flat from infinity to about 1.5 D of defocus, indicating that patients can probably see without glasses for everything except reading fine print.

“This is not quite the same level of spectacle independence that patients can get with a multifocal IOL. On the other hand, patients implanted with the Tecnis Symfony IOL do not seem to experience dysphotopsias. So, this is an exciting development,” he said, adding that he expects it will wed well to a toric platform.

Dr. Olson noted that the Symfony IOL is being carefully released in Europe and surgeons who are implanting it are being asked to participate in a Phase 4 trial designed to gather more data on patient outcomes. The FDA Phase 3 study is already underway so that if all goes well, the Symfony IOL might be available in the US by late 2016 or early 2017.

Otherwise, premarketing development programs are continuing for other novel presbyopia-correcting lenses, including the piezoelectric lens (Sapphire AutoFocal IOL, Elenza) and the FluidVision accommodating IOL (PowerVision). However, approval does not appear to be on the horizon for any of those technologies.

Dr. Packer said, “The FluidVision deformable optics design is probably the nearest thing we have to a true accommodating lens. There is objective evidence that demonstrates accommodation with that technology, and some positive functional results have been reported from a multicenter trial that is being conducted at sites in Europe. However, the FluidVision IOL is still relatively early in clinical development, and with a US trial not expected to start until next year, there is still a long road to its becoming commercially available in this country,” Dr. Packer said.

Another novel lens that has completed its first in man study is the Harmoni Modular IOL from ClarVista Medical (FIGURE X). Malik Kahook, MD, inventor of the IOL, noted, “The Harmoni system is designed to allow optic exchange for refractive surprise and/or multifocal lens intolerance and optimization of toric IOL position if rotation is required post implantation.”

He said these maneuvers can be completed while avoiding manipulation of the capsular bag due to the novel modular design. The base component of the lens system also allows for a capsular tension ring like effect and resulted in improved effective lens position and excellent stability for months post implantation.

“The multiple barriers to posterior capsular opacification (PCO) present in the base component resulted in superior prevention of PCO in preclinical studies done at the Moran Eye Center. The Harmoni IOL system is positioning itself as the life cycle lens for all patients with the ability to address refractive needs from pediatrics to adulthood and promises to give surgeons flexibility to target optimum vision as no lens has in the past,” said Dr. Kahook.

Addressing dysphotopsia

As he discussed during his ASCRS Binkhorst Lecture in 2012, Dr. Olson reiterated that IOL-related dysphotopsia is a common problem in patients who have undergone cataract surgery but being largely ignored by most IOL manufacturers. Aware of the issue, Samuel Masket, MD, designed an IOL that would specifically prevent negative dysphotopsia. Dr. Masket received a U.S. patent for his IOL, the lens was picked up by Morcher, and it received the CE Mark in 2013. A variation on the bag-in-the lens technique, the IOL’s optic features a peripheral groove placed anteriorly to accept the anterior capsulotomy and a lip that overrides the anterior capsule.

“I take my hat off to Sam for coming up with a design to address dysphotopsias because I believe it is the biggest complaint of patients who have had uncomplicated cataract surgery and the number one unmet need for that population,” Dr. Olson said.

Incision sealing technology

In January 2014, Ocular Therapeutix received FDA approval for use of its hydrogel product (ReSure Sealant) to seal clear corneal incisions after cataract surgery. Dr. Olson noted the Moran early studies investigating the sealant’s performance were conducted at the Moran Eye Center, Although he questioned the clinical relevancy of the test used to provoke leaking, which involved external point pressure application, Dr. Olson said that findings from those and other studies show definitively that the product works well to seal incisions.

“The sealant may even work better than a suture, and it is also very comfortable for patients and avoids the extra visit that may be needed for suture removal. Cost may be an issue that would limit its use in routine cataract surgery cases, but I think it will have an important niche role when there is concern that the incision is not sealing well,” Dr. Olson said.

Dr. Packer agreed that the sealant is clearly effective and has advantages of comfort and convenience compared with suturing. He noted that the need to have a dry surface for the sealant to adhere creates a conundrum considering that the product is intended for use when the incision is leaking. However, surgeons can address that issue by first deflating the anterior chamber and then drying the surface before applying the sealant. Once the product has set, the eye can be reinflated through the side port incision, he said. 

Dr. Packer also observed that price will be a factor governing use of the seal.

“Routine utilization of the sealant in cataract surgery will be limited by the realities of reimbursement. However, I think it is a winner as a value-added product for premium surgery procedures where it can maintain incision integrity to help prevent infection without the downsides of a stitch,” he said.

Guiding capsulorhexis

Another novel device for cataract surgery introduced this year is the VERUS capsulorhexis device from Mile High Ophthalmics. This device is leveraged to create a perfectly centered and sized capsulotomy without the cost and disruption of operating room flow that is present with femtosecond lasers, said Dr. Kahook, inventor of the device.

He noted, “The VERUS device can be placed over the capsule prior to starting the rhexis and then acts as a guide for creating a precisely sized continuous curvilinear capsulorhexis. The capsulotomy is created in a fashion similar to tearing a paper against a flat ruler placed on a table. This technique is made possible by the micropattern on the bottom of the device that acts as a lateral breaking system to avoid movement of the device during the procedure.”

The VERUS will be available for purchase in the first quarter of 2015 (for more information: www.milehighophthalmics.com).

Malik Kahook, MD

E: malik.kahook@ucdenver.edu

Dr. Kahook is a consultant to Alcon Laboratories, Allergan, ClarVista Medical, Aerie Pharma and the FDA. He has intellectual property interests with Abbott Medical Optics, Glaukos, New World Medical, Oasis, ClarVista Medical and Prospex Medical.

Randall Olson, MD

E: randallj.olson@hsc.utah.edu

Dr. Olson has no relevant financial interests to disclose.

Mark Packer, MD

E: mark@markpackerconsulting.com

Dr. Packer is a consultant to Alcon Laboratories, Bausch + Lomb, PowerVison, and Rayner.