Meeting News Coverage

Physicians, industry, investors convene for the Ophthalmology Innovation Summit, part 2

CHICAGO – Ocular Surgery News has captured the substance and spirit of the remarks made by the speakers here at the Ophthalmology Innovation Summit’s Device, Delivery and Diagnostic Company Showcase.

Tim Willis, TearScience co-founder and CEO, discussed the company’s U.S. Food and Drug Administration-cleared product to identify, diagnose and treat meibomian gland dysfunction.

Willis: The company has 325 commercial customers with 55,000 patient treatments. The majority of customers pay off the product in less than 12 months. At this meeting we are introducing the LipiView II, with dynamic meibomian imaging. We were already addressing the function of the gland, but now we have added the structure of the gland in the image. And this comes with reimbursement.

In the TearScience trial that looked at LipiFlow treatment at 1 year, 90% of patients had a threefold increase in gland function, 80% of patients had more than a 50% reduction in symptoms, and 87% of patients received no other meibomian gland disease or dry eye treatment. Full results will be presented at AAO this week.

Thomas G. Frinzi, president and CEO of Wavetec Vision Systems discussed the company’s journey to today.

Frinzi: At 9:40 a.m. today, we closed our transaction with Alcon. I think it is safe to say innovation in ophthalmology is alive and well.

We have improved the outcome of 250,000 cataract patients. Intraoperative guidance is the new standard of care. With Alcon, we have opportunity for continued growth.

Barry Cheskin, president and CEO of PowerVision, discussed a fluid-controlled accommodating IOL.

Cheskin: PowerVision is developing FluidVision, a fluid-controlled accommodating IOL. The PowerVision approach is to harness natural muscular forces in the eye to move fluids around the lens. In doing that, it creates a shape change, which leads to a large change in power. The shape change is many times more optically efficient than designs with a shifting or vaulting lens. With FluidVision, when the eye moves to its natural accommodated state, the capsular bag, which now contains our IOL, squeezes a tiny amount of fluid from the haptics at the periphery of our IOL into the center. This inflates our lens, giving near vision.

FluidVision is paired with the PowerJect “injector.” The PowerJect delivery system delivers the lens into the capsular bag, with little or no change to the surgical procedure, and the lens comes preloaded for ease of use. We’ve systematically proved our effect and performance.

David Muller, PhD, president and CEO of Avedro, discussed the company’s clinical trials for cross-linking.

Muller: Avedro is reaching new heights in corneal cross-linking. We are halfway through enrollment in our multicenter CE mark trial in South Africa and Germany. We expect the CE mark in 2015, and U.S. FDA clinical trials are expected in 2015.

The first thing we are looking at is LASIK Xtra. In a study of LASIK Xtra vs. LASIK, patients achieving 20/30 or better uncorrected visual acuity was 100% vs. 73%.

We are developing a procedure that results in regional stiffening of the cornea: photorefractive intrastromal cross-linking or PiXL. A prospective clinical trial is underway and will include 40 eyes with myopia and astigmatism. The first case was treated recently by Burkhard Dick, MD. The initial report is that the patient is happy, and the doctor is very happy.

In addition, we're starting two new trials in the U.S. next year: LASIK Xtra, then PiXL with KXL II, with Brillouin microscopy as a diagnostic. We hope for approval in the first quarter of 2015 for cross-linking with KXL.

Max G. Ostermeier, MBA, co-founder and general manager, Implandata Ophthalmic Products GMBH, discussed plans for the company’s 24-hour IOP monitoring device.

Ostermeier: We are investigating a device that would replace hospital-based monitoring. This method is temporary, but we are looking into permanent 24-hour IOP monitoring via implantable sensors. We have developed a microsensor device. It is minimally invasive and sits behind the iris, and it is easy for a patient to take readings themselves via a smartphone app. It is designed for simple patient self measurement. The measurement is sent via a GSM module to a database, allowing the eye doctor to access patients’ IOP data.

We are working on various product versions: The ARGOS-IO for pseudophakic or aphakic eyes would be primary implantation in the ciliary sulcus, like an add-on IOL in primary open-angle glaucoma patients, and the ARGOS 02 for secondary implantation for patients with the Boston K-Pro. We are also working on a version for glaucoma patients, the Horizon, which can be combined with other products such as IOLs, K-Pros, drainage devices and closed-loop therapeutic systems.

Our clinical plan is to achieve the CE mark by the end of next year and two indications in 2016, with the first in-human study next year.

Russell Trenary, president and CEO of InnFocus, discussed clinical trials involving the MicroShunt.

Trenary: We are currently conducting the first and only randomized U.S. FDA trial against trabeculectomy, the “gold standard.” Glaucoma is a great space to be in.

The InnFocus MicroShunt surgical results are not temporary. The secret sauce is the material. The SIBS material is ultra-stable and won't degrade. It is repeatable in all quadrants.

We are aiming at providing safe, effective and easy treatment for early-stage to late-stage POAG patients. We are looking to implant 150 patients with more than 20 doctors in six countries.

The InnFocus MicroShunt is successful with and without cataract procedures and repeatable.

In a 3-year study in the Dominican Republic and France, preoperative baseline IOP in 59 patients was 23.1 mm Hg. At year 3, 22 patients had 95% success with an IOP of 10.7 mm Hg, representing a mean drop in IOP of 54%, and 100% of patients had IOP less than or equal to 18 mm Hg. Eight-two percent of patients had an IOP less than or equal to 14 mm Hg. Seventy-three percent of glaucoma patients are off preop medications meds at year 2. All adverse events resolved spontaneously.

Ronen Castro, CEO of IOPtima, discussed World CLASS Study results.

Castro: The CLASS (CO2 laser-assisted sclerectomy surgery) procedure ablates thick layers of the scleral tissue in a way the human hand cannot.

In the World CLASS Study there was a 36% reduction in complications compared to trabeculoplasty at 3 years, a 33.1% reduction in vision loss compared to trab and a 39% reduction in cataract development compared to trab. The CLASS procedure provided an IOP reduction comparable to trabeculectomy at 3 years; medication reduction was similar in both groups at 3 years.

There was a success rate of 87% after 3 years with the IOPtiMate System and a low frequency of complications. We are in discussions with the FDA.

With CLASS, we provide a novel laser-assisted surgical tool that enables eye surgeons to perform a very accurate deep sclerectomy glaucoma surgery. It reduces the elevated IOP by thinning the sclera without penetrating the eyeball. The IOPtiMate System for CLASS integrates to any ophthalmic microscope. It is simple to perform with a minimal learning curve.

Jeroen Cammeraat, CEO of i-Optics, discussed the first year of commercialization of Cassini Total Corneal Astigmatism.

Cammeraat: With the premium IOL expansion there is a need for excellent diagnostics for corneal astigmatism. I-Optics' Cassini, which is being launched here at AAO, addresses this. Cassini outperforms Schiempflug in our clinical study and provides you with the right preoperative data.

Recent clinical studies have shown repeatability of the Cassini anterior corneal steep axis of less than 3 degrees, and 7 degrees for total posterior. Cassini shows contribution of the posterior cornea to total corneal astigmatism, and the accuracy further increases 0.21 D for all eyes (against-the-rule and with-the-rule astigmatism). These are very exciting outcomes with the Cassini device.

In the study of 111 patients across nine sites with 3-year follow-up and more than 800 procedures, we had a reduction of IOL similar to trabeculectomy, and there was a low frequency of complications.

Quinton Oswald, president and CEO of Neurotech, discussed the company’s Encapsulated Cell Therapy.

Oswald: Encapsulated Cell Therapy is a proprietary first-in-class drug delivery platform for the continuous production of therapeutic proteins in the eye.

We have demonstrated efficacy with NT-503, a VEGF-antagonist being developed to treat wet AMD. No adverse events have led to discontinuation. One patient experienced sterile endophthalmitis, which resolved without sequelae.

We will initiate a phase 2 trial involving 150 patients in early 2015. We’ve been in contact with the FDA and had a preliminary meeting with them to develop guidances for covering all aspects of development.

John Maroney, CEO of ForSight Visions, discussed the Helios insert.

Maroney: ForSight Visions, which is debuting at the OIS, seeks to develop noninvasive, sustained drug delivery in the anterior eye. We target noncompliant patients and those who are unable to use or have difficulty using glaucoma drugs.

Our focus is 6 months duration of delivery. We have a robust pipeline in glaucoma, dry eye and chronic and seasonal allergy, but our primary focus is glaucoma: POAG and ocular hypertension.

Highly effective treatments exist; prostaglandin drops reduce the likelihood of progression by 34% to 42% per year. However, many patients are noncompliant. Sixteen percent return with uncontrolled IOP, 14% require a care giver to administer the drops, 17% run out, and 26% forget. The Helios insert is a simple, noninvasive ring that is meant to be tucked under the eyelid, eliminating the need for daily drops. It can be reapplied during the normal course of therapy. The drug release is predictable and gradual. It’s molecular diffusion through the cornea and sclera.

The phase 2 study was started a year ago, and enrollment was reached by April 2014. The study looked at 130 patients, with patients randomized to receive either the active product or placebo with timolol. Data will be available in December. A phase 3 study is expected to begin in 2015. Ninety-five percent of patients found the device comfortable.

Robert Butchofsky, founder and CEO of Mati Therapeutics, discussed Evolute, its Punctal Plug Delivery System.

Butchofsky: Mati uses punctal plugs to deliver drugs and puts the control back in the hands of doctors to ensure that patients are getting the correct amount of drug treatment. It provides a consistent drug delivery that eliminates the need for patients to self-administer their medication and provides potential for more consistent IOP control.

The program initially started at QLT in 2007. The initial data, quite frankly, wasn’t that great. But we have made multiple adjustments and are now seeing good results.

The Mati Therapeutics Punctal Plug Delivery System (PPDS) Evolute is designed to be in place for 90 days. The company is planning to enter phase 3 trials in 2015. The first product candidate used in the Evolute platform will be latanoprost.

Twelve-week study results in phase 2 trials are showing a consistent 5 mm Hg to 10 mm Hg reduction in IOP.

Overall, the product is delivering consistent long-term efficacy, has a duration of effect of 12 weeks, has a high retention rate (92%) and is relatively easy to insert and remove.

Amarpreet Sawhney, PhD, president and CEO, Ocular Therapeutix, discussed several of the company’s sustained-release platforms.

Sawhney: Our primary focus is an anterior segment sustained-release therapy. Our 1-month steroid is in phase 3 trials, with up to 3 months of prostaglandin glaucoma treatment in phase 2 trials. Also, Resure sealant was FDA-approved as a first-of-its-kind ocular sealant.

We are also developing posterior segment sustained-release injections. Feasibility studies are ongoing for a 6-month sustained-release anti-VEGF.

Results from the phase 2 study on the steroid OTX-DP for the treatment of chronic allergic conjunctivitis showed strong efficacy compared with placebo.

Our near-term milestones are to initiate enrollment for the phase 2b trial for OTX-TP to treat glaucoma and complete phase 3a and 3b clinical trials for OTX-DP for postsurgical inflammation and pain. We plan for submission of a New Drug Application in the second quarter of 2015.

Dan Myers, president and CEO of Alimera Sciences, discussed the recent Iluvien approval.

Myers: A key moment for us was 3 weeks ago when Iluvien was approved. Iluvien is indicated for diabetic macular edema (DME) treatment in patients who have previously been treated with a course of corticosteriods and had no clinically significant rise in IOP. The current treatment before this approval was burdensome to patients.

We are learning more about DME; there is now a body of evidence that it is a multifactorial disease, and anti-VEGF alone is probably not the solution.

We are introducing the product here at AAO and are building the commercial and production infrastructure in the U.S. The price point is between $8,000 and $9,000. – by Samantha Costa, David Mullin and Joan-Marie Stiglich

CHICAGO – Ocular Surgery News has captured the substance and spirit of the remarks made by the speakers here at the Ophthalmology Innovation Summit’s Device, Delivery and Diagnostic Company Showcase.

Tim Willis, TearScience co-founder and CEO, discussed the company’s U.S. Food and Drug Administration-cleared product to identify, diagnose and treat meibomian gland dysfunction.

Willis: The company has 325 commercial customers with 55,000 patient treatments. The majority of customers pay off the product in less than 12 months. At this meeting we are introducing the LipiView II, with dynamic meibomian imaging. We were already addressing the function of the gland, but now we have added the structure of the gland in the image. And this comes with reimbursement.

In the TearScience trial that looked at LipiFlow treatment at 1 year, 90% of patients had a threefold increase in gland function, 80% of patients had more than a 50% reduction in symptoms, and 87% of patients received no other meibomian gland disease or dry eye treatment. Full results will be presented at AAO this week.

Thomas G. Frinzi, president and CEO of Wavetec Vision Systems discussed the company’s journey to today.

Frinzi: At 9:40 a.m. today, we closed our transaction with Alcon. I think it is safe to say innovation in ophthalmology is alive and well.

We have improved the outcome of 250,000 cataract patients. Intraoperative guidance is the new standard of care. With Alcon, we have opportunity for continued growth.

Barry Cheskin, president and CEO of PowerVision, discussed a fluid-controlled accommodating IOL.

Cheskin: PowerVision is developing FluidVision, a fluid-controlled accommodating IOL. The PowerVision approach is to harness natural muscular forces in the eye to move fluids around the lens. In doing that, it creates a shape change, which leads to a large change in power. The shape change is many times more optically efficient than designs with a shifting or vaulting lens. With FluidVision, when the eye moves to its natural accommodated state, the capsular bag, which now contains our IOL, squeezes a tiny amount of fluid from the haptics at the periphery of our IOL into the center. This inflates our lens, giving near vision.

PAGE BREAK

FluidVision is paired with the PowerJect “injector.” The PowerJect delivery system delivers the lens into the capsular bag, with little or no change to the surgical procedure, and the lens comes preloaded for ease of use. We’ve systematically proved our effect and performance.

David Muller, PhD, president and CEO of Avedro, discussed the company’s clinical trials for cross-linking.

Muller: Avedro is reaching new heights in corneal cross-linking. We are halfway through enrollment in our multicenter CE mark trial in South Africa and Germany. We expect the CE mark in 2015, and U.S. FDA clinical trials are expected in 2015.

The first thing we are looking at is LASIK Xtra. In a study of LASIK Xtra vs. LASIK, patients achieving 20/30 or better uncorrected visual acuity was 100% vs. 73%.

We are developing a procedure that results in regional stiffening of the cornea: photorefractive intrastromal cross-linking or PiXL. A prospective clinical trial is underway and will include 40 eyes with myopia and astigmatism. The first case was treated recently by Burkhard Dick, MD. The initial report is that the patient is happy, and the doctor is very happy.

In addition, we're starting two new trials in the U.S. next year: LASIK Xtra, then PiXL with KXL II, with Brillouin microscopy as a diagnostic. We hope for approval in the first quarter of 2015 for cross-linking with KXL.

Max G. Ostermeier, MBA, co-founder and general manager, Implandata Ophthalmic Products GMBH, discussed plans for the company’s 24-hour IOP monitoring device.

Ostermeier: We are investigating a device that would replace hospital-based monitoring. This method is temporary, but we are looking into permanent 24-hour IOP monitoring via implantable sensors. We have developed a microsensor device. It is minimally invasive and sits behind the iris, and it is easy for a patient to take readings themselves via a smartphone app. It is designed for simple patient self measurement. The measurement is sent via a GSM module to a database, allowing the eye doctor to access patients’ IOP data.

PAGE BREAK

We are working on various product versions: The ARGOS-IO for pseudophakic or aphakic eyes would be primary implantation in the ciliary sulcus, like an add-on IOL in primary open-angle glaucoma patients, and the ARGOS 02 for secondary implantation for patients with the Boston K-Pro. We are also working on a version for glaucoma patients, the Horizon, which can be combined with other products such as IOLs, K-Pros, drainage devices and closed-loop therapeutic systems.

Our clinical plan is to achieve the CE mark by the end of next year and two indications in 2016, with the first in-human study next year.

Russell Trenary, president and CEO of InnFocus, discussed clinical trials involving the MicroShunt.

Trenary: We are currently conducting the first and only randomized U.S. FDA trial against trabeculectomy, the “gold standard.” Glaucoma is a great space to be in.

The InnFocus MicroShunt surgical results are not temporary. The secret sauce is the material. The SIBS material is ultra-stable and won't degrade. It is repeatable in all quadrants.

We are aiming at providing safe, effective and easy treatment for early-stage to late-stage POAG patients. We are looking to implant 150 patients with more than 20 doctors in six countries.

The InnFocus MicroShunt is successful with and without cataract procedures and repeatable.

In a 3-year study in the Dominican Republic and France, preoperative baseline IOP in 59 patients was 23.1 mm Hg. At year 3, 22 patients had 95% success with an IOP of 10.7 mm Hg, representing a mean drop in IOP of 54%, and 100% of patients had IOP less than or equal to 18 mm Hg. Eight-two percent of patients had an IOP less than or equal to 14 mm Hg. Seventy-three percent of glaucoma patients are off preop medications meds at year 2. All adverse events resolved spontaneously.

Ronen Castro, CEO of IOPtima, discussed World CLASS Study results.

Castro: The CLASS (CO2 laser-assisted sclerectomy surgery) procedure ablates thick layers of the scleral tissue in a way the human hand cannot.

PAGE BREAK

In the World CLASS Study there was a 36% reduction in complications compared to trabeculoplasty at 3 years, a 33.1% reduction in vision loss compared to trab and a 39% reduction in cataract development compared to trab. The CLASS procedure provided an IOP reduction comparable to trabeculectomy at 3 years; medication reduction was similar in both groups at 3 years.

There was a success rate of 87% after 3 years with the IOPtiMate System and a low frequency of complications. We are in discussions with the FDA.

With CLASS, we provide a novel laser-assisted surgical tool that enables eye surgeons to perform a very accurate deep sclerectomy glaucoma surgery. It reduces the elevated IOP by thinning the sclera without penetrating the eyeball. The IOPtiMate System for CLASS integrates to any ophthalmic microscope. It is simple to perform with a minimal learning curve.

Jeroen Cammeraat, CEO of i-Optics, discussed the first year of commercialization of Cassini Total Corneal Astigmatism.

Cammeraat: With the premium IOL expansion there is a need for excellent diagnostics for corneal astigmatism. I-Optics' Cassini, which is being launched here at AAO, addresses this. Cassini outperforms Schiempflug in our clinical study and provides you with the right preoperative data.

Recent clinical studies have shown repeatability of the Cassini anterior corneal steep axis of less than 3 degrees, and 7 degrees for total posterior. Cassini shows contribution of the posterior cornea to total corneal astigmatism, and the accuracy further increases 0.21 D for all eyes (against-the-rule and with-the-rule astigmatism). These are very exciting outcomes with the Cassini device.

In the study of 111 patients across nine sites with 3-year follow-up and more than 800 procedures, we had a reduction of IOL similar to trabeculectomy, and there was a low frequency of complications.

Quinton Oswald, president and CEO of Neurotech, discussed the company’s Encapsulated Cell Therapy.

Oswald: Encapsulated Cell Therapy is a proprietary first-in-class drug delivery platform for the continuous production of therapeutic proteins in the eye.

PAGE BREAK

We have demonstrated efficacy with NT-503, a VEGF-antagonist being developed to treat wet AMD. No adverse events have led to discontinuation. One patient experienced sterile endophthalmitis, which resolved without sequelae.

We will initiate a phase 2 trial involving 150 patients in early 2015. We’ve been in contact with the FDA and had a preliminary meeting with them to develop guidances for covering all aspects of development.

John Maroney, CEO of ForSight Visions, discussed the Helios insert.

Maroney: ForSight Visions, which is debuting at the OIS, seeks to develop noninvasive, sustained drug delivery in the anterior eye. We target noncompliant patients and those who are unable to use or have difficulty using glaucoma drugs.

Our focus is 6 months duration of delivery. We have a robust pipeline in glaucoma, dry eye and chronic and seasonal allergy, but our primary focus is glaucoma: POAG and ocular hypertension.

Highly effective treatments exist; prostaglandin drops reduce the likelihood of progression by 34% to 42% per year. However, many patients are noncompliant. Sixteen percent return with uncontrolled IOP, 14% require a care giver to administer the drops, 17% run out, and 26% forget. The Helios insert is a simple, noninvasive ring that is meant to be tucked under the eyelid, eliminating the need for daily drops. It can be reapplied during the normal course of therapy. The drug release is predictable and gradual. It’s molecular diffusion through the cornea and sclera.

The phase 2 study was started a year ago, and enrollment was reached by April 2014. The study looked at 130 patients, with patients randomized to receive either the active product or placebo with timolol. Data will be available in December. A phase 3 study is expected to begin in 2015. Ninety-five percent of patients found the device comfortable.

Robert Butchofsky, founder and CEO of Mati Therapeutics, discussed Evolute, its Punctal Plug Delivery System.

Butchofsky: Mati uses punctal plugs to deliver drugs and puts the control back in the hands of doctors to ensure that patients are getting the correct amount of drug treatment. It provides a consistent drug delivery that eliminates the need for patients to self-administer their medication and provides potential for more consistent IOP control.

PAGE BREAK

The program initially started at QLT in 2007. The initial data, quite frankly, wasn’t that great. But we have made multiple adjustments and are now seeing good results.

The Mati Therapeutics Punctal Plug Delivery System (PPDS) Evolute is designed to be in place for 90 days. The company is planning to enter phase 3 trials in 2015. The first product candidate used in the Evolute platform will be latanoprost.

Twelve-week study results in phase 2 trials are showing a consistent 5 mm Hg to 10 mm Hg reduction in IOP.

Overall, the product is delivering consistent long-term efficacy, has a duration of effect of 12 weeks, has a high retention rate (92%) and is relatively easy to insert and remove.

Amarpreet Sawhney, PhD, president and CEO, Ocular Therapeutix, discussed several of the company’s sustained-release platforms.

Sawhney: Our primary focus is an anterior segment sustained-release therapy. Our 1-month steroid is in phase 3 trials, with up to 3 months of prostaglandin glaucoma treatment in phase 2 trials. Also, Resure sealant was FDA-approved as a first-of-its-kind ocular sealant.

We are also developing posterior segment sustained-release injections. Feasibility studies are ongoing for a 6-month sustained-release anti-VEGF.

Results from the phase 2 study on the steroid OTX-DP for the treatment of chronic allergic conjunctivitis showed strong efficacy compared with placebo.

Our near-term milestones are to initiate enrollment for the phase 2b trial for OTX-TP to treat glaucoma and complete phase 3a and 3b clinical trials for OTX-DP for postsurgical inflammation and pain. We plan for submission of a New Drug Application in the second quarter of 2015.

Dan Myers, president and CEO of Alimera Sciences, discussed the recent Iluvien approval.

Myers: A key moment for us was 3 weeks ago when Iluvien was approved. Iluvien is indicated for diabetic macular edema (DME) treatment in patients who have previously been treated with a course of corticosteriods and had no clinically significant rise in IOP. The current treatment before this approval was burdensome to patients.

We are learning more about DME; there is now a body of evidence that it is a multifactorial disease, and anti-VEGF alone is probably not the solution.

We are introducing the product here at AAO and are building the commercial and production infrastructure in the U.S. The price point is between $8,000 and $9,000. – by Samantha Costa, David Mullin and Joan-Marie Stiglich

    See more from American Academy of Ophthalmology Meeting