Congratulations to the ONL team on reaching significant milestones in 2021. This tranche of funding will further expand three programs and move ONL1204 closer to the clinic.
We'd like to thank and congratulate Mr. Esposito, Dr. Zacks, and the ONL team for this accomplishment. The ExSight team is looking forward to the next steps in the journey, advancing these programs into Phase 2 of the US regulatory process.
CEO, David Esposito commented, "We are excited to have reached our critical milestones, advancing ONL1204 into open-angle glaucoma and GA associated with dry AMD. With the support of our investors, we are grateful for the opportunity to further expand our development program into two chronic indications, each with significant unmet medical needs, while also working to close out our Phase 1 study in retinal detachment."
Read the full press release here.
Bonus: Dr. Rahhal's Podcast with the ONL CEO - From West Point to ONL's C-Suite
Dr. Rahhal sits down with Craig Simak, OIS co-founder, and fellow OIS podcast hosts, Robert Rothman, MD (InFocus Capital Partners) and Ehsan Sadri, MD, FACS (Visionary Ventures) to discuss the OIS 2021 Year in Review: Shrugging Off the Pandemic Blues.
Their conversation provides insights and context to the OIS report from their unique perspectives as clinician-VCs. One insight shared by each was that the ophthalmic investment landscape is and will remain full of opportunities to meet growing unmet needs.
Key takeaways from the OIS Year in Review include:
Congratulations to lensgen team on this significant milestone: IDE Approval from the U.S. FDA to Begin Clinical Study
Great news for LensGen, Inc. The approval of their IDE will allow the company to begin their pivotal trial with the ultimate goal of seeking premarket approval. Congratulations to Ram and the team! Their persistence and dedication is inspiring.
LensGen, Inc., a privately held ophthalmic medical device company, announced today that it has received approval for an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal study of the company's Juvene intraocular lens (IOL) for patients with cataracts.
The LensGen Juvene IOL is designed to permanently restore clear and continuous vision at all distances including near and intermediate. The lens is modular and has a fluid optic component that changes shape to adjust focus on demand for today's active lifestyles, from viewing mobile devices and computer screens to high-quality distance vision in a broad range of lighting conditions. The lens is implanted using the same surgical techniques used with traditional intraocular lenses. Full press release.
Watch LensGen's Panel Discussion at ASCRS in Las Vegas Last August
ExSight Ventures ("EV") is pleased to announce our investment in ELT Sight, Inc. ("ELT"). ELT is focused on safe and effective microinvasive glaucoma surgery with its next generation ELIOS™ procedure. The funding will enable the company’s United States FDA clinical trial. ELT’s innovative ELIOS™ procedure uses an excimer laser to lower eye pressure in people with glaucoma and has already received a CE mark in Europe. The ELIOS™ excimer laser system is a unique approach to minimally invasive glaucoma surgery (“MIGS”) with significant advantages over current technologies.
The Glaucoma Research Foundation estimates that by the year 2040, 111 million people will have glaucoma. MIGS has revolutionized the glaucoma treatment and management paradigm to treat patients whose IOP is not controlled by medications and those requiring surgery. Consequently, MIGS technologies have been an area of high interest for EV since our founding in 2014. However, many of the opportunities we reviewed did not present a clear advantage to approved and existing procedures. “We have been searching for a MIGS procedure that would improve the treatment paradigm in early and moderate glaucoma in a meaningful way for patients,” said EV partner Dr. Nissen.
The ELIOS™ system expands on what it means to be truly minimally invasive, which we believe will have a significant clinical and therapeutic advantage over existing technologies. Current popular MIGS procedures involve inserting an implant while ELT’s technology uses a precision laser and leaves no implant behind. The ELIOS™ system creates new microchannels in the trabecular meshwork while preserving tissue integrity and avoiding scarring. “ELT’s novel procedure has all the attributes that will make it highly attractive to cataract surgeons and glaucoma specialists alike: efficacy, simplicity, speed, reproducibility, and a lack of hardware left in the eye, among others,” added EV partner Dr. Rahhal.
Our investment in ELT is unique in that we were able to review numerous clinical studies containing data on more than 800 human eyes. A recent review article that undertook a comprehensive analysis of 10 clinical studies. “Current Review of Excimer Laser Trabeculostomy” was published in the BioMed Central journal Eye and Vision and authored by Georges M. Durr, Marc Toeteberg-Harms, Richard Lewis, Antonio Fea, Paola Marolo, and Iqbal Ike K. Ahmed.
“In the review article of non-industry funded studies from independent investigators at more than a dozen centers across multiple countries including Italy, Germany, Switzerland, and Spain, use of the IOP-lowering device following an established method in open-angle glaucoma patient populations demonstrated a degree of IOP lowering equal or superior to those achieved with other MIGS. The results were reproducible across the centers, with significant, durable IOP reduction that in some studies lasted to 5–8 years. Complication rates were low, both when used as a stand-alone procedure and in combination with cataract surgery.” (press release)
ELT is a unique opportunity to invest in a company with clinically proven technology and an exceptional team of ophthalmic professionals and clinical advisors at an early stage.
“We’re thrilled to have ExSight Ventures as ELT’s first institutional investor. Their unique expertise investing in early-stage ophthalmic companies provides meaningful validation of our ELIOS™ technology,” said Elliot Friedman, CEO of ELT. “We’re excited to partner with them in our pursuit of U.S. regulatory approval.”
The ELT team has developed a safe and effective procedure that embodies the "minimally invasive" part of MIGS. We're excited to partner with ELT and their exceptional team of ophthalmic professionals and clinical advisors to help bring this critical therapeutic technology through the regulatory approval process to patients.
 Glaucoma Research Foundation
 Current review of Excimer laser Trabeculostomy
An article about Trefoil Therapeutics was included in the May 27 electronic version of a special Innovation in Ophthalmology Biopharma Dealmakers publication. Hard-copies will be published in mid-June.
The lead article is titled Partnering to Improve Vision and includes a short summary of the 100 ophthalmic transactions over the past five years.
The Trefoil article, Restoring Vision Loss with a Regenerative Therapy: One molecule, two products; how Trefoil Therapeutics engineered FGF1 (TTHX1114) to enable the treatment of multiple diseases affecting the cornea, can be found here.
The piece includes this excerpt:
The technology underlying Trefoil’s engineered FGF1, TTHX1114, builds on the well-known activities of native FGF1 to enable its use as a pharmaceutical for corneal diseases. FGF1 is a potent stimulator of cell proliferation and migration, and has cell protective properties, all key attributes for its use in endothelial disease (Fig. 1). The compound uniquely activates all seven forms of FGF receptors, contributing to its potency. Although FGF1’s activities are well known, native FGF1 has a short half-life, which renders it unsuitable as a pharmaceutical agent.
Read the full article.
We were first introduced to DTx founder and CEO Artie Suckow in June 2017. DTx formed to unlock RNA therapeutics' promise and overcome challenges inherent in delivering this therapeutic class to an array of different tissues and cell types.
DTx had identified ocular indications as an area of interest to prove their potential revolutionary platform technology, now called FALCON™. This matched up with one pillar of ExSight's investment thesis, the eye's unique "features make it an ideal proving ground for breakthrough technologies." This is particularly so for CNS therapeutics because the retina is part of the brain. Not surprisingly, DTx also had CNS targets in their development plan.
We stayed in touch with Artie and followed as they executed a development plan remarkably consistent with our investment strategy.
The successful Series B raise is a testament to Artie and the entire DTx team's vision and execution. They've been joined by a respected group of new and existing investors to advance clinical development into several therapeutic areas, including ocular, neuromuscular, and CNS diseases. We enthusiastically continued our support into this $100 million Series B.
If you'd like to join an impressive team of innovators and problem-solvers, DTx is hiring.
After watching and listening to Dr. Rahhal's many episodes hosting the OIS Retina Podcast we joined him in this week's installment. Firas was having so much fun talking ophthalmic innovation with his other guests we wanted to get in on the action.
Our wide-ranging discussion touched on everything from the history and formation of ExSight, how we operate with two very busy vitreoretinal surgeons, our investment process, a pair of portfolio companies, and much more. The conversation lasted nearly an hour but it wasn't enough to mention all of the outstanding portfolio companies and teams, our investors, advisors, and founding members. Hopefully we'll have a chance to do a deeper dive at some point. We hope you enjoy the conversation.
The below is taken from an update we shared with our investors, portfolio companies, and friends as 2020 came to a close. We share some of these reflections here as well. We're hopeful and optimistic that 2021 will bring much more positivity and wish everyone well in the new year.
As so many of us do today, we are reflecting on the past year. 2020 was a historic and tragic year by any measure though not without silver linings. We're focusing on several positive accomplishments and critical milestones as we enter a new year.
These accomplishments helped us find many silver linings and remain positive throughout the year. We thank the teams of each of these companies and all of our portfolio companies for their tenacity, perseverance, and dedication to advancing ophthalmic innovation.
Beyond retinal detachment, lead candidate ONL1204 will also advance into the chronic conditions of glaucoma and dry age-related macular degeneration
ExSight Ventures completes and amplifies follow on investment in ONL Therapeutics
ONL Therapeutics, Inc. (“ONL”), a clinical-stage biopharmaceutical company and ExSight Ventures (“EV”) portfolio company, announced it closed a $46.9 million Series B financing. EV syndicated $3.75 million. ONL is developing novel therapies for protecting the vision of patients with retinal disease. This funding will enable the completion of the company’s Phase 1 study in retinal detachment with ONL’s lead compound ONL1204 while advancing ONL1204 programs in two chronic indications, glaucoma and dry age-related macular degeneration.
ONL1204 is a novel, first-in-class small molecule fatty acid synthase (“Fas”) inhibitor designed to protect the retina from cell death via both direct and inflammatory signaling in a range of retinal diseases. Fas is a known inducer of apoptosis or cell death. The death of critical retinal cells is the root cause of vision loss and is implicated in a wide range of retinal diseases, including glaucoma, age-related macular degeneration (AMD), and inherited retinal degeneration (IRD; also known as retinitis pigmentosa).
Bios Partners led the round with additional participation from new investors Johnson & Johnson Innovation – JJDC, Inc., Kaitai Capital, PSQ Capital, and Michigan Capital Network Venture Fund III. Bios Partners has been an excellent partner and lead investor for another EV portfolio company, Trefoil Therapeutics. We’re gratified by their investment in ONL and have immediately seen the impact of their non-financial support. “Bios Partners has been instrumental in working with our team to build the syndicate and strengthen our plans,” stated David Esposito, ONL CEO.
Dr. Rahhal is quickly becoming a prolific podcaster. In this week's roundup Firas hosts three podcasts with another impressive list of guests offering different perspectives on ophthalmic innovation.
Retina from the Catbird's Seat
In this third OIS Retina Podcast, host Firas Rahhal, MD, sat down with Paul Hallen, VP, Global Head, Retina and Glaucoma, at Alcon, who talks about how he grew with the company over 31 years and provides an engineer’s perspective on how far innovation in retina surgery has come, and where it’s heading.
Watch the conversation on YouTube.
Au Petit Bonheur la Chance
In the fourth installment of the OIS Retina Podcast guest is French-born Patricia Zilliox, who boomeranged back to her homeland to become president and CEO of Eyevensys. Before that she’d spent 25 years with Alcon before joining the Foundation Fighting Blindness as chief drug development officer. Having spent so much time evaluating new therapies at FFB, she was intrigued by Eyevensys’ unique platform to enable the sustained intraocular production of therapeutic proteins to treat a broad range of ophthalmic disease. Listen to hear Patricia share more details on Eyevensys’ lead product: a gene therapy to treat uveitis.
Watch the conversation here.
Treating Challenge as Opportunities
In this episode of the OIS Retina Podcast, Firas is joined by legendary vitreoretinal specialist and serial entrepreneur, Mark Blumenkranz, MD, MMS. It hasn’t always been smooth sailing in the start-up ship, but Dr. Blumenkranz persevered and now shares his proven recipe for ophthalmic innovation. (Hint: It starts with an unmet need.) Dr. Blumenkranz also talks about his investment/incubation firm Lagunitas Biosciences and drug delivery start-up Kedalion Therapeutics.
Watch the conversation here.