Device, Delivery, & Diagnostic Company Showcase

Device, Delivery, & Diagnostic Company Showcase
Chicago—The 6th Annual Ophthalmology Innovation Summit (OIS), held here prior to the annual American Academy of Ophthalmology (AAO) featured a plethora of intriguing early- to mid-stage companies focused in the medical devices arena.

A regular presenter in past OIS meetings has been Tom Frinzi, President and CEO of WaveTec Vision (Aliso Viejo, California). Frinzi has always portrayed an exciting picture of his company’s innovative intraoperative aberrometry technology, which has rapidly emerged as an important diagnostic tool for enhancing visual outcomes in cataract surgery.

Frinzi kicked off his talk here with the cheerful news for all WaveTec shareholders (mostly VCs) and employees, announcing that the purchase of the company by Alcon Inc., a division of Novartis AG, had been completed.

The culmination of this deal, which was originally announced in late August, is in great part testimony to Frinzi’s inspirational and savvy leadership, which enabled WaveTec to rejuvenate its technology and marketing strategy and become an attractive acquisition candidate for the ophthalmic industry juggernaut Alcon.

Frinzi has long asserted that its VerifEye technology is a “must have” for cataract surgery. Although the purchase price was not publicly disclosed, ophthalmic industry pundits reckon it to be about $350 million in cash, all up front with no future milestone payments. Relative to WaveTec’s modest but growing revenue base of approximately $15 million, this represents a multiple on annual revenue of about 23 times.

To put this into perspective, medical device acquisitions prices typically fall in the range of two times annual revenue at the low end to ten times (very rarely) at the high end, so clearly WaveTec’s exit supports Frinzi’s contention about “must have.” The purportedly high, up-front purchase price reflects Alcon’s burning desire to capitalize on WaveTec’s dominant number one position in the estimated $7 billion worldwide cataract market.

Alimera Sciences Inc. (Alpharetta, Georgia) President and CEO Dan Myers presented another upbeat story, discussing FDA’s long awaited approval in late September of his company’s intravitreal implant Iluvien.

This proprietary device delivers a corticosteroid to patients suffering from diabetic macular edema (DME), providing a sustained, therapeutic effect for up to 36 months with one injection/implantation. It is specifically indicated for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

Myers indicated that over time, it appears that “DME becomes more of an inflammatory disease,” hence the value of a sustained release formulation of an anti-inflammatory corticosteroid.

Alimera plans to launch IIuvien in the U.S. with a direct sales force of 32 reps in Q1-2015. Myers pointed out that Iluvien addresses an enormous market opportunity, which he pegged at over $1 billion globally. While domestic pricing has not yet been finalized, Myers noted that Iluvien is priced at 5,500 British pounds ($9,000) and 7,900 Euros ($10,000). It is logical, therefore, to expect that U.S. pricing will be in the same ballpark.

InnFocus (Miami) President and CEO Russ Trenary provided an update of his company’s status, noting that the huge prevalence of glaucoma worldwide (which he estimated at over 75 million globally) affords a “tremendous opportunity” for innovative devices. Trenary, who joined the company in 2013, stated that InnFocus’ MicroShunt glaucoma drainage implant is made from a revolutionary material that is ultra-stable and does not degrade.

According to Paul Palmberg, MD, PhD, a glaucoma specialist with a private practice in Miami, “the eye doesn’t know this material is in the eye.”

One of the key differentiating attributes of the InnFocus approach is that its outstanding intraocular pressure (IOP) lowering capability is successful with or without cataract surgery. Additionally, it can be used in early- to late-stage glaucoma patients.

The company’s clinical trials outside the U.S. have conclusively demonstrated that the MicroShunt provides durable results, with IOP reduction at three months very closely aligned with the three-year results.

In the past year, InnFocus has been conducting the first randomized controlled study against trabeculectomy, the gold standard in managing later-stage glaucoma patients.

By early 2015, the company will have data with up to three years of follow-up on approximately 150 patients implanted by over 20 doctors in 6 countries in non-randomized trials. The data available thus far on patients implanted outside the U.S. and followed for three years includes: (1) IOP reduction of over 50% from baseline (on full meds) to under 14mm Hg; (2) more than 80% of eyes with IOP ≤ 14 mmHg; (3) an 84% reduction in glaucoma meds to 0.5 med/patient; (4) over 70% of patients entirely off eye drops at three years. There have been no long-term sight-threatening adverse events.

Domestically, InnFocus is in the midst of a Phase I trial, with enrollment of 75 patients expected to be completed in early 2015. Patients are randomized 2:1 versus a traditional trabeculectomy. Trenary further added that he hopes that InnFocus will begin its pivotal U.S. trial in mid-2015, with the goal to enroll 412 patients, randomized 3:1 against trabeculectomy.

ForSight VISION5 Inc. CEO John Maroney discussed his company’s novel, non-invasive insert system Helios. The device delivers the “drug of choice” prostaglandin A (PGA) with a diffusion-mediated release from a polymer. The PGA diffuses in a gradual, controlled, and predictable manner through the polymer and releases into the tear film. In turn the PGA in the tear film diffuses to the back of the eye and impacts IOP.

Maroney pointed out that despite their widespread usage (an estimated two million patients in the USA are using PGA as a first-line treatment), clear-cut benefits (a 35-40% reduction per year in the likelihood of disease progression), and an outstanding safety profile, less than 50% of patients continue using a PGA past one year. He stated that these non-compliant patients represent a “key unmet need” and that sustained release medications address the “treatment burden of glaucoma.” According to independent market research commissioned by ForSight, a simple effective product like Helios would have strong market adoption.

Maroney reported that the Helios insert (without PGA) was tested at three clinical sites for two months in 39 patients and 37 completed the two-month study.

“This provided us the confidence to start a Phase II study in the U.S.,” he said. In this Phase II study, 130 subjects were randomized on a 1:1 basis, with half receiving a PGA insert and placebo drops and the other half receiving another glaucoma medication (timolol) and a placebo insert. The final data from this study will be available before year-end 2014.

Another early-stage company addressing the massive glaucoma market, and a newcomer to the OIS forum was Mati Therapeutics Inc. CEO Bob Butchofsky reiterated the well-documented issues with glaucoma medications and noted that they are five main challenges to all sustained drug delivery platforms. These are: (1) consistent long-term efficacy and treatment effect; (2) high retention rates; (3) ease of use, replacement, and acceptance for years of administration; (4) no residual carrier left behind that cannot be easily removed; (5) a pathway of reimbursement for the patient and the physician for the insertion of the delivery device.

Mati’s device, Evolute, is a minimally invasive sustained delivery platform which uses punctal plugs to deliver drugs, initially for glaucoma.

This project was initially started in 2007. Early results were disappointing, with a modest 3mm Hg IOP reduction. With additional development, Butchofsky said that a new formulation has yielded much better results, with a far higher retention rate in eyes, a twelve-week duration of effect, and a 5-6mm Hg IOP decline over 12 weeks.

The company has now completed multiple Phase II dose-ranging trials in 570 patients and has seen dramatically better retention rates (92% with the current design). Butchofsky indicated that they are planning to enter a Phase III pivotal trial in 2015 delivering a PGA drug.

PowerVision Inc. President and CEO Barry Cheskin provided a concise update on the clinical trial status of his company’s proprietary FluidVision accommodating intraocular lens (IOL). Cheskin reiterated his longstanding theme, which is, “FluidVision is the only technology that restores true accommodation.” It does so by efficiently harnessing the natural muscular forces of accommodation in the eye to move fluids inside the lens. That fluid movement causes a shape change, which leads to a large change in the power of the IOL. This lens is delivered with the novel pre-loaded PowerJect IOL injector system.

A total of about 100 patients outside the U.S. have been implanted with FluidVision. Roughly half of these patients have been implanted in the company’s CE Mark trial, which will ultimately enroll 115 patients as the company strives for an approval. PowerVision plans to begin its FDA trial sometime in 2015.

Cheskin also reported that the final tranche of its $30 million Series D has been completed. Based on previously reported information, PowerVision has raised approximately $95-100 million since its founding in 2004.