David Hutton

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 This transcript has been lightly edited for clarity.

 Hi, this is Sean O'Neil, Chief Commercial Officer of ViaLase. Excited to be at the Eyecelerator meeting at AAO and provide an update on ViaLase milestones.

ViaLase is a medical device company, it's venture backed, out of Southern California. We are focused on disrupting the current conventional glaucoma treatment paradigm with the introduction of a non-invasive, image-guided femtosecond laser to address primary open angle glaucoma.

The leadership team has a vast experience in femtosecond lasers, designing, manufacturing, commercializing, the first femtosecond laser for both refractive as well as cataract and now looking to take that knowledge and leverage it within the glaucoma marketplace.

I'm excited to announce that the founder and CEO Dr. Tibor Juhasz was recently awarded the 2022 Golden Goose Award in recognition of his and his fellow researchers, finding that femtosecond lasers can make corneal incisions with high precision without damaging adjacent tissues, which revolutionized the LASIK marketplace. And we look forward to ViaLase taking that experience and recreating it and that success for glaucoma patients.

As we know with glaucoma, glaucoma treatment paradigm is typically driven by a trade-off thought process. If you want more efficacy, you typically have to give up safety. We're designing our technology to bring those into balance. And the technology is designed to create a femtosecond laser, image-guided, high-precision trabeculotomy, what we're calling the FLigHT treatment.

The FLigHT treatment again is is to include OCT-driven femtosecond laser delivery for safety and efficacy but also with an intuitive learning curve, so that is accessible to all surgeons, glaucoma specialist and cataract surgeons alike. And we're we're also working on a business model so that there is value for all stakeholders.

We're excited to provide here, at AAO Eyecelerator, a case series of data to assess safety and efficacy of an 18 patient case series non-washed-out, so real-world out to 24 months. 24 months is important in glaucoma because you want that long-term data to assess both safety as well as durability of treatment.

Of the patients in the cohort out to 24 months, they demonstrated a 31% IOP reduction and also excited to say that 100% of them achieved the 20% or greater IOP reduction, all with a very safe profile.

This data is very encouraging and we look forward to demonstrating our results in a multicenter, randomized controlled trial that is currently ongoing. Finally we are in the process of getting CE mark and we're also preparing for our submission to the FDA for 510K clearance and look forward to keeping you updated on those milestones as we prepare for commercialization.

Videos

Shawn O'Neil of ViaLase shares updates on the company's femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT) treatment.

Disrupting the glaucoma treatment paradigm with novel femtosecond laser from ViaLase

According to the companies, ML6710i is a transportable ophthalmic laser that is controlled from an iPad mobile application.

Bausch + Lomb Corp. and biomedical laser firm Modulight Oyj announced Wednesday the US Food and Drug Administration has approved their ML6710i photodynamic laser for use with the eye-health company's photodynamic therapy, Visudyne.

Visudyne (verteporfin for injection) photodynamic therapy (PDT) is for the treatment of patients with predominantly classic subfoveal choroidal neovascularisation, or the creation of abnormal choroidal blood vessels, due to age-related macular degeneration (AMD). ML6710i is expected to be available for eye care professionals during the first half of 2023.

In a news release, Christina Ackermann, president, Ophthalmic Pharmaceuticals, Bausch + Lomb, pointed out that PDT continues to be an important treatment option for eye care professionals who are looking to treat patients with predominantly classic subfoveal choroidal neovascularisation.

“The approval of ML6710i, eye care professionals now have a new state-of-the-art photodynamic laser that addresses a significant unmet need in PDT and is specifically designed to deliver VISUDYNE to patients who suffer from wet AMD with persistent fluid,” she said in the release.

According to the companies, ML6710i is a transportable ophthalmic laser that is controlled from an iPad mobile application. The laser’s beam shaping unit, which can be fit into all common slit lamps used for eye examinations, is formed into a circular, uniform spot to enable efficient treatment delivery of Visudyne.

“As a result of our efforts with Bausch + Lomb, along with the feedback that many eye care professionals provided to our teams, we are thrilled to bring forward an innovative cloud connected laser platform that the ophthalmology community can use to deliver VISUDYNE to patients in need of treatment of choroidal neovascularisation due to AMD,” Seppo Orsila, founder and CEO, Modulight, said in the release.

Visudyne is an injectable photosensitizer drug that is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to AMD, pathologic myopia or presumed ocular histoplasmosis. It is activated through use of a photodynamic laser via direct laser excitation, delivering a targeted approach that specifically destroys abnormal choroidal blood vessels to help prevent further disease progression and help patients maintain their vision.

Articles

According to a news release from Bausch + Lomb and biomedical laser company Modulight, the FDA has approved the ML6710i photodynamic laser for equivalent use with Visudyne.

US FDA approves to Ml6710i laser for use with Visudyne

Apellis Pharmaceuticals Inc. announced that the company has submitted a marketing authorisation application (MAA) to the European Medicines Agency for intravitreal pegcetacoplan, an investigational, targeted C3 therapy, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

GA is a leading cause of blindness that impacts more than 5 million people globally.1,2

“Along with the upcoming FDA decision in the U.S., the submission of our EU marketing application brings us closer than ever toward our goal of delivering pegcetacoplan to patients living with GA around the world,” said Jeffrey Eisele, PhD, chief development officer at Apellis. “If approved, pegcetacoplan would be the first and only treatment for GA in Europe.”

Frank G. Holz, DERBY and OAKS study investigator and professor and chairman of the department of ophthalmology at the University of Bonn, Germany, pointed out that pegcetacoplan is the only GA treatment to demonstrate increased effects over 24 months across a broad patient population.

“There are currently no treatments to slow the progression of GA, a life-altering disease that causes substantial vision loss, so the potential approval of pegcetacoplan would be a significant milestone for patients in Europe,” he said in a statement.

The MAA submission is based on results from the Phase 3 DERBY and OAKS studies at 24 months. In the studies, treatment with both every-other-month and monthly pegcetacoplan demonstrated robust and clinically meaningful reductions of GA lesion growth, with treatment effects that increased over time, and a favourable safety profile.

The U.S. marketing application is under review with a Prescription Drug User Fee Act (PDUFA) target action date of February 26, 2023.


DERBY (n=621) and OAKS (n=637) are Phase 3, multicenter, randomised, double-masked, sham-controlled studies comparing the efficacy and safety of pegcetacoplan with sham injections across a broad and representative population of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The primary objective of the studies is to evaluate the efficacy of pegcetacoplan in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence (p-value less than .05) at 12 months. Patients continued to receive masked treatment for 24 months.

Pegcetacoplan is the only GA treatment to demonstrate increased effects over 24 months across a broad patient population.

Apellis submits marketing authorisation application to the European Medicines Agency for pegcetacoplan for geographic atrophy

Re-Vana Therapeutics Ltd. announced the closure of its Series A round with $11.9 million in funding, an oversubscription of $4 million. 

The financing was led by Visionary Ventures. Additional investors include ExSight Ventures, InFocus Capital Partners and current UK investors Quibis Ltd, Co-Fund NI and TechStart Ventures.

The proceeds will advance the development of Re-Vana's novel and proprietary photo-crosslinked EyeLief, EyeLief-SD and OcuLie biodegradable drug delivery technologies and will enable expansion of the company's operations and development teams.

With the successful completion of key nonclinical ocular safety, tolerability and efficacy studies, Re-Vana has demonstrated that its platform can achieve 6 months or greater sustained delivery of an anti-VEGF biologic at therapeutically relevant levels with high drug loading, controlled burst release, and a favourable degradation profile.

According to the company, its platform has the potential to enable sustained drug delivery via non-surgical administration in office-based settings to treat ocular disease, overcoming several long-standing limitations and challenges in the field.

In conjunction with this financing, Re-Vana's board of directors has been further strengthened by the appointments of Robert Avery, MD, of Visionary Ventures and InFocus Capital Partners, as board member, and Michael O'Rourke, President and CEO of Re-Vana Therapeutics, as Board Chairman.

"Financing from new and existing investors during this challenging time is a testament to the potential of Re-Vana's technologies for sustained delivery of biologic therapeutics," O'Rourke said in a prepared statement. "We are especially fortunate to have received follow-on financing from multiple, highly respected, US ophthalmic-focused venture capital firms and UK investors. Their proven knowledge and expertise in ophthalmology are invaluable additions to Re-Vana as we accelerate the development of our pipeline and expand our strategic partnerships."

"Re-Vana's proprietary technology platforms offer significant potential to deliver both novel and approved biologics for at least 6 months in the clinic, reducing the need for frequent intravitreal injections and extending therapeutic efficacy in the treatment of major eye diseases," Avery pointed out.

Re-Vana is a technology spin-out from Queen's University, located in Belfast, Northern Ireland. The company is currently developing sustained release ophthalmic therapeutics aimed at reducing the frequency of intravitreal injections required to treat a wide range of retinal diseases, including wet age-related macular degeneration. 

In addition, Re-Vana's proprietary photo-crosslinked, sustained-release technology may enable the development of a broad range of novel, sustained-release products applicable to a variety of therapeutic areas.

The funding will give a boost to the development of the company's novel photo-crosslinked EyeLief, EyeLief-SD, and OcuLie biodegradable drug-delivery technologies.

Author | David Hutton

Articles

US FDA approves to Ml6710i laser for use with Visudyne

Apellis submits marketing authorisation application to the European Medicines Agency for pegcetacoplan for geographic atrophy

Re-Vana Therapeutics raises $11.9 million to advance ophthalmic technology platforms

Disrupting the glaucoma treatment paradigm with novel femtosecond laser from ViaLase