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- 👀 Eye you tired
👀 Eye you tired
Raj Mitra
March 27, 2024
Good morning, Blink & Skimmers! ☕️ Do you ever stare at your phone and wonder if a grandma has replaced you? Well, this week (March 19th-25th) is your chance to celebrate the eye detectives who keep our vision sharper than a drone enthusiast spotting a real one in the sky (seriously, get your eyes checked, friend!). It's World Optometry Week, all about making sure everyone has access to great eye care! Here's to healthy eyes for all!
P.S. Bonus history fact for you history buffs (or anyone who needs an excuse to eat cake): Today, March 27th, also marks the day explorer Juan Ponce de León first spotted what is now Florida, way back in 1513! Maybe he just needed a good optometrist to find that elusive Fountain of Youth... ⛲️
"It does not matter how slowly you go as long as you do not stop."
In this edition:
Good News: 2nd Drug for Geographic Atrophy (GA)
Iveric Bio's GA Treatment Izervay Granted Permanent J-code
Here are two GA drugs on the market.
Big news for macular degeneration patients! Iveric Bio, an Astellas company, announced their therapy for geographic atrophy (GA) has been approved by the FDA. This is coupled with a critical step towards wider use, a permanent J-code assigned by CMS. This code streamlines billing and reimbursement for Izervay, the company's treatment for GA, potentially leading to faster access for patients.
20-Second Vacation for Your Eyes
Don't Let Screens Steal Your Sight! Celebrate Save Your Vision Month with the 20-20-20 Rule
20-20-20 RULE
Celebrate Save Your Vision Month by giving your eyes a break! The 20-20-20 rule is a simple yet effective way to combat eye strain from digital screens. Every 20 minutes, look away for 20 seconds at something 20 feet distant. This allows your focusing muscles to relax and reduces dryness and irritation. So next time you're glued to a screen, remember to give your eyes a quick 20-second vacation – it's a great way to take care of your precious peepers throughout the year, especially during Save Your Vision Month in March!
Eye Research Updates
Smart Contact Lenses for Early Glaucoma Detection: A Promising Development
Purdue University photo/Rebecca McElhoe
In the rapidly evolving landscape of eye care, a groundbreaking advancement is making waves: glaucoma monitoring systems integrated into contact lenses. This innovative technology represents a beacon of hope for millions worldwide, transforming the battle against glaucoma, a leading cause of irreversible blindness. This exciting tech, funded by a $6.7 million grant, offers hope for millions battling sight-threatening glaucoma.
Researchers at Purdue University are developing a game-changer for eye health: smart contact lenses. These lenses, built on existing soft contact lens designs, utilize StickTronics technology to continuously monitor intraocular pressure, a key indicator of glaucoma. Unlike traditional, often uncomfortable tonometers, these smart lenses are soft and comfortable to wear. These lenses offer the potential for 24/7 IOP monitoring, including during sleep, and could even pave the way for future treatment options.
80 million people worldwide are battling glaucoma, a sight-stealing disease. But there's a glimmer of hope! Researchers are developing smart contact lenses that use tiny sensors to detect glaucoma early. This $6.7 million project is a game-changer, combining education with cutting-edge tech. Stay tuned for future trials - these lenses could revolutionize eye care!
Gene Therapy Takes Flight: Aiming to Halt AMD in Space!
Trial in Space
A revolutionary gene therapy designed to combat age-related macular degeneration (AMD) is blasting off on a SpaceX mission! This first-of-its-kind space experiment will test the therapy's ability to protect vision in microgravity, mimicking the oxidative stress seen in intermediate AMD, a stage where current treatments fall short.
Oculogenex, the developer, hopes this groundbreaking research paves the way for future clinical trials and treatments, offering new hope for millions struggling with this vision-stealing disease.
Eyepatch? Nah, This New Contact Lens is a Healing Superhero (with a Built-in Timer)!
Researchers have developed a new contact lens material called GelMA+ that shows promise in healing corneal wounds. This innovative material is designed to degrade over time in response to enzymes present in tears, releasing medication to aid the healing process.
Key highlights:
GelMA+ is stronger and more durable than previous materials, making it suitable for contact lens applications.
The material degrades in the presence of enzymes in tears, allowing for sustained and controlled drug delivery.
This targeted release can potentially adjust to the severity of the wound, delivering more medication when needed.
GelMA+ has the potential to revolutionize how we treat corneal injuries. While further research is needed, this study represents a significant step forward in developing improved bandage contact lenses for faster and more effective healing. An innovative approach to addressing a variety of eye ailments and disorders through a non-invasive, economical therapy.
AI in EYE
Eye See AI: Supercharging Healthcare with a Wink
Supercharging AI in Ophthalmology
Ever feel like your eyes hold secrets about your health? Well, they might just! AI in eye care is becoming a reality, using super-smart scans to analyze your peepers for hidden clues about sneaky diseases like diabetes or kidney problems.
Here's the exciting part: these AI detectives are getting even smarter! Researchers are combining eye info with other intel from your brain scans or blood tests, creating a disease-fighting dream team. Plus, cool tech like blockchain keeps your eye data safe and secure.
Of course, there's still some fine-tuning to do, but the future of AI in eye care is looking sharp (pun intended!). It has the potential to revolutionize healthcare, and that's something we can all get behind (or should I say, see clearly!).
Bonus Fun Fact 👉️ Doctors have known for a long time that the eye is like a window to your overall health. That's because the eye shares many of the same building blocks, like blood vessels and nerves, with other organs in your body. So, changes in your eye can sometimes be a sign of something bigger going on elsewhere!
Clinical Trials
Dry Eye Relief on the Horizon: New Treatment Gets FDA Go-Ahead
Dry eye sufferers, rejoice! A biotech company called iView Therapeutics just got the green light from the FDA to test a new treatment called IVW-1001. Millions worldwide struggle with dry, scratchy eyes, and let's face it, those artificial tears can be a drag. This new option works differently, targeting the root causes of dry eye with a novel TRPM8 agonist mechanism. Unlike artificial tears that simply add moisture, IVW-1001 goes after the underlying problem.
Exciting news! iView Therapeutics' IVW-1001 cleared by FDA for Phase 1/2 trials, potentially revolutionizing dry eye treatment, with trials set to begin in Q2 2024.
Eye Drop Offers Hope for Diabetic Eye Disease
Diabetics with sight-threatening eye diseases may soon have a new, more convenient treatment option. Exonate Ltd. announced positive results from a mid-stage clinical trial (Phase Ib/IIa) of EXN407, a first-in-class eye drop targeting a specific protein (SRPK1) that contributes to abnormal blood vessel growth in diabetic retinopathy and macular edema. The trial demonstrated that EXN407 is safe and shows biological activity, meaning it interacts with the intended target. This paves the way for a larger Phase IIb trial (CLEAR-DM) designed to assess EXN407's effectiveness in reducing the need for injections, a common treatment for these conditions.
Promising Gene Therapy for Rare Blindness Shows Early Success
In a recent update, Opus Genetics completed dosing in the first stage of a clinical trial for a gene therapy called OPGx-LCA5, which uses a modified virus (AAV8) to carry a working version of the LCA5 gene directly to the outer layer of the retina in LCA5 patients. LCA5, a rare genetic disease causing early-onset blindness, strikes about 1 in 1.7 million Americans. Here's the best part: some patients who were practically living in a blackout are now reporting seeing shapes and objects for the first time! We're talking folks who have been navigating the world in total darkness for years.
Gene Therapy Shows Promise in Restoring Vision for Patients with Advanced Retinitis Pigmentosa
A gene therapy trial shows promise for treating retinitis pigmentosa (RP), a currently incurable genetic disease causing blindness. Nanoscope Therapeutics' MCO-010 significantly improved vision in a randomized trial, regardless of the specific genetic mutation. Patients experienced vision improvement lasting at least 76 weeks, offering hope for millions. The company plans to submit a BLA to the FDA later in 2024.
This is significant progress for a disease with no current cure, affecting roughly 100,000 people in the U.S. and millions worldwide. Based on these results, Nanoscope plans to submit a Biologics License Application (BLA) to the U.S. FDA in the second half of 2024.
Nicox's Glaucoma Drug Shows Promise in Published Trial Results
Nicox's experimental glaucoma treatment, NCX 470, a Nitric Oxide-Donating Bimatoprost, demonstrated positive results in a key Phase 3 trial (Mont Blanc). Published in the American Journal of Ophthalmology, the study suggests NCX 470 could become a leading choice for lowering intraocular pressure, a major factor in glaucoma management. The company expects confirmation of these findings in a second Phase 3 trial (Denali) due later in 2025.
Belite Bio Submits US IND Amendment to Advance Tinlarebant for Stargardt Disease
Belite Bio's Tinlarebant is a potential breakthrough for Stargardt Disease (STGD1), a genetic cause of vision loss in children and young adults. Early results from a 24-month trial showed the drug may slow disease progression. Tinlarebant is an oral medication that reduces harmful toxins in the eye. This treatment is also being studied in a separate trial for Geographic Atrophy, a complication of Dry Age-related Macular Degeneration (AMD). With a completed Phase 3 enrollment and interim data expected later this year, Tinlarebant could offer new hope for those battling inherited and age-related vision loss.
Relief for Dry Eyes in Two Weeks: OK-101 Eyedrops Shine in Trial
OKYO Pharma's OK-101 eyedrop shows promise for treating dry eye disease (DED). In a clinical trial, patients experienced significant relief from multiple symptoms within just two weeks, including pain, burning, blurred vision, and dryness. OK-101 also demonstrated excellent comfort and tolerability, with no serious side effects reported. These results suggest that OK-101 could be a valuable option for those struggling with dry eye disease. These results support OK-101's potential as a leading treatment for DED.
What else to skim?
Dual Approach for Glaucoma: Surgery May Cut Medication Need
A new study investigated combining cataract surgery with a tiny medical device called an iStent Inject to treat glaucoma. This device is placed within the eye during cataract surgery to help improve drainage and potentially reduce reliance on glaucoma medications. Researchers found that after two years, patients who received the iStent Inject alongside cataract surgery needed significantly fewer glaucoma medications compared to those who only had cataract surgery. Importantly, the vision and safety outcomes were similar between the two groups.
Microdrops: Effective Eye Drop Delivery with Potential Safety Benefits
A new study looked at a different way to deliver eye drops called microdrops. These are smaller than usual drops and use a special adapter. The study found microdrops worked just as well as conventional ones but may have fewer side effects. This could be a promising new approach for delivering eye medication.
Alcon Welcomes Esteemed Ophthalmologist Dr. Terry Kim as Chief Medical Officer
Alcon appoints renowned ophthalmologist Dr. Terry Kim, Professor of Ophthalmology at Duke University Eye Center, as Chief Medical Officer, succeeding Dr. Stephen S. Lane. Dr. Kim brings expertise in cornea, cataract, and refractive surgeries to align clinical priorities and advance eye care innovations globally.
Business
LENZ Therapeutics Completes Merger with Graphite Bio Announces Upcoming Milestones for Potential Presbyopia Treatment
LENZ Therapeutics, a company developing eye drops for presbyopia (age-related near vision loss), has finalized its merger with Graphite Bio. This paves the way for commercializing their innovative eye drops, LNZ100 and LNZ101.
Key Highlights:
Positive Phase 2 Results: Both LNZ100 and LNZ101 significantly improved near vision in clinical trials with a good safety profile.
Phase 3 Trials Completed: The pivotal Phase 3 CLARITY trials for both drugs have finished enrolling patients. Topline results are expected in April 2024.
Planned NDA Submission: Based on these results, LENZ plans to submit a New Drug Application (NDA) to the FDA by mid-2024.
Commercialization Strategy: LENZ intends to launch the most effective product in the US with its own sales team. They're also exploring partnerships for other markets.
Financial Strength: The merger and a recent private placement provide LENZ with the resources needed to commercialize their chosen product candidate.
Presbyopia affects millions, and LENZ is on track to potentially offer a first-in-class treatment with an NDA filing expected by mid-2024.
Clearside Biomedical Reports Progress in Suprachoroidal Delivery Platform
Clearside Biomedical, a biopharmaceutical company focused on delivering treatments to the back of the eye, reported its financial results for the fourth quarter and full year 2023.
Key Highlights:
Progress on CLS-AX:
Their lead drug candidate, CLS-AX for wet age-related macular degeneration (AMD), is in a Phase 2b clinical trial named ODYSSEY.
Topline data for this trial is expected in the third quarter of 2024.
Early results show a promising safety profile and stable vision in patients.
Financial Highlights:
The company reported a net loss, but it decreased compared to 2022 due to an upfront license fee from a new partner.
They completed a stock offering in February 2024, raising $15 million.
With this new funding, Clearside believes they can operate until the third quarter of 2025.
Partnerships:
Clearside signed a licensing deal with BioCryst Pharmaceuticals to use their SCS Microinjector® delivery device for a treatment targeting diabetic macular edema (DME).
Other partners are also using Clearside’s technology in their clinical trials.
Overall, Clearside is making progress in developing sight-saving treatments for patients with eye diseases.
Kiora Pharmaceuticals Advances Pipeline with Strong Financial Position
Kiora Pharmaceuticals, a company focused on treatments for rare retinal diseases, reported positive financial results and advancements in its drug development pipeline.
Key highlights:
Partnership with Théa Open Innovation to develop KIO-301, a potentially vision-restoring therapy for inherited retinal diseases.
Phase 2 clinical trial for KIO-301 is expected to begin later this year.
Progress on KIO-104, an anti-inflammatory treatment for non-infectious uveitis.
Strong cash position expected to fund operations through 2026.