Premium IOLs: Two Outliers with Mainstream Potential
A problem that plagues refractive cataract surgery is the difficulty of determining the IOL power that will achieve each patient’s refractive target.
In the old days, if a post-cataract patient wasn’t satisfied with their vision, they simply wore a pair of glasses. But patients paying thousands of dollars for a premium IOL are not satisfied with that outcome. They want to get rid of glasses.
Hundreds of millions of dollars have been invested in devices to improve pre-operative and even intra-operative biometry that will allow more precise determination of IOL power. However, surprises still occur at an unacceptable rate.
The Light Adjustable Lens
Made by Calhoun Vision of Pasadena, CA, the light adjustable lens (LAL) aims to end the refractive surprises that put a crimp in the premium IOL market. Long in development, Calhoun was founded in 1997 by a Nobel-prize winning Cal Tech chemist and a San Francisco ophthalmologist.
The basic idea was to develop a lens chemistry that would allow the power of the lens to be corrected after implantation and healing. (Correcting the power of current IOLs requires either glasses or significant additional surgery.) With the LAL, two or three weeks after surgery a precisely aimed dose of ultraviolet light is applied to the lens (in the eye), which eliminates any residual refractive error and then locks in the change.
A robust technology, the LAL can correct both spherical and astigmatic refractive error as well as offer several different approaches to giving patients vision at near, intermediate, and far distances.
In June of this year Calhoun announced receipt of $52 million in new financing and an additional $17 million in debt conversion. The financing round was led by Longitude Capital with co-investors H.I.G. BioVentures, Balance Point Capital Partners, and RA Capital Management.
While not yet approved in the US, the LAL lens is commercially available in Mexico, the UK, and parts of Europe. Its 600-patient US clinical trial is fully enrolled, and proceeds from the recent financing will be used to complete the US FDA pre-market process and execute Calhoun’s strategy “to transform the landscape of cataract surgery for patients and physicians.”
Giving credence to that claim, Calhoun’s executive suite is populated by people with deep experience in the eye care space. In March of 2015, Calhoun hired Rick Heinick from Bausch+Lomb as President and Chief Executive Officer; and in June he was joined by Ron Kurtz, MD, in the position of Chief Operations Officer, and Eric Weinberg as Chief Commercial Officer. Both were top level veterans of IntraLase and LenSx, two of the most successful ocular surgery device startups in recent memory. (Ophthalmology veteran Andy Corley also took over as chairman of Calhoun’s board. See our profile on the company.)
Well behind the LAL in commercialization is the WIOL-CF, a “bioanalogic” and “polyfocal” IOL developed by the Medicem Institute in the Czech Republic. While the Medicem Institute may not be a household name in the US, it is the organization that grew from the bio-materials laboratory of Otto Wichterle, who is widely credited as the father of soft contact lenses. Like soft contacts, the WIOL-CF is made from a hydrogel material that Medicem describes as bioanalogic because it mimics some of the properties of living ocular tissue.
An aspheric and accommodating IOL, the WIOL-CF achieves its results through its design and material, which were developed to give it many of the properties of the natural crystalline lens. Indeed, the WIOL-CF is similar to the crystalline lens in diameter, shape, certain material properties, and function.
Because it adheres tightly to the posterior capsule, and at 8.9 mm in diameter almost fills the capsular bag, the WIOL-CF does not need haptics. This allows it to have a much larger optical zone than current IOLs, which the company claims improves quality of vision. More importantly, the hyperbolic aspheric curvature of the lens gives increased depth of field and pseudo-accommodation driven by pupil constriction.
In a 43-patient study reported at the ESCRS in 2014, at three months post-surgery, patients’ mean uncorrected distance vision was 20/20, and 100% of patients were 20/25 or better. Their mean uncorrected near vision was reasonable (J3.3 or about 20/30), while their intermediate vision was excellent at J1.2 (essentially 20/20). As expected in an IOL without zonal boundaries, contrast sensitivity was good. At three months, 91% of patients were spectacle free, and only one patient reported disturbing glare and halos.
With respect to commercialization, the WIOL-CF is CE marked and available in the EU and some other international markets. Medicem is holding back on full commercialization pending further clinical trials to optimize the lens prior to a full product launch.
According to its Co-Founder and CEO, Eugen Chicevic, MD, MBA, Medicem is considering whether or not to seek a strategic partner for full commercialization. He notes that the company has recently inked an agreement with Bausch+Lomb for joint funding and execution of European clinical trial of the lens. He plans for US IDE in 2018.