In Atlanta, Georgia, the OIS @ SECO Innovation Showcase highlighted the best and the brightest optometric and ophthalmic drugs, therapies, and tech we hope to see come to fruition.
On March 1, Paul Karpecki, OD, FAAO, director of cornea and external disease at Kentucky Eye Institute, associate professor at Kentucky College of Optometry, kicked off the Innovation Showcase of the Ophthalmic Innovation Summit (OIS) at SECO 2023. The presentations spanned from gene therapy for neurotrophic keratitis (NK) to a volume-reducing adaptor for dropper bottles.
OIS has been present at ophthalmology meetings since 2017, but it is still relatively new to optometry. The evolution makes sense: Optometry touts an estimated growth of 10% from 2021 to 2031.1 Meanwhile, eye care as a whole must contend with the staggering increase in average age of the population, which correlates to increased rates of cataracts, age-related macular degeneration, and other age-related ocular diseases that are often referred out to ophthalmologists.
“Optometry is only going to grow because we don’t have enough surgeons,” Karpecki stressed. “And surgeons want to do surgery.”
From portable osmolarity testing to drug-eluting contact lenses for pain management, the eye care industry is keeping optometrists at the forefront of their latest tech. What follows below is just a slice of the innovation happening within eye care.
First, there are many blockbuster PDUFA dates set for 2023:
Each of these companies presented pipeline updates at OIS@SECO, though not all during the Innovation Showcase. Presenters at the Innovation Showcase included Jeffrey Nau, PhD, president of the eye care division at Viatris; Benjamin Sullivan, PhD, chief scientific officer of Trukera Medical; Monty Montoya, CEO of TherOptix; Chris Adams, CEO of Glint Pharmaceuticals; Mackenzie Andrews, chief commercial officer of Nanodropper; and Todd Brady, MD, PhD, CEO of Aldeyra Therapeutics.
Though the eye care division of Viatris is new (established January 3, 2023), the acquisition of Oyster Point and Famy Life Sciences created a strong lead in the industry. Tyrvaya (varenicline solution) is already approved by the FDA, and Viatris hopes that MR-140 phentolamine ophthalmic solution 0.75% (Nyxol) for reversal of mydriasis follows soon. This indication of Nyxol, formulated by Ocuphire and acquired by Viatris via Famy Gen Life Sciences, has a PDUFA date set for September 28, 2023, according to Nau.
Viatris is also investigating OC-101 AAV-nerve growth factor (NGF) gene therapy injection for the treatment of neurotrophic keratopathy stage 2 and 3. In Investigational New Drug (IND) enabling studies, the injection lasts up to 42 days, and NGF production is measured as early as day 7. These statistics will be put to the test in the first-in-human trial, which is set to begin in 2024.
Formerly known as TearLab, Trukera Medical has not let the rebrand slow them down. They have been gathering speed with the portable osmolarity testing system, ScoutPro. Decreasing osmolarity increases tear production in patients with MGD, but moving patients to a separate area for testing disrupts the flow of the exam and may cause traffic issues within the office. The ScoutPro is portable, practical, and precise, Sullivan underscores. The handheld device can be used in the exam room and produces results in under 15 seconds.
“The future of innovation has to include optometry,” Monty Montoya said at the beginning of his presentation. The work done at TherOptix supports this claim. The company is investigating 2 non-refractive, drug-eluting bandage lenses: DexaLens for proliferative vitreoretinopathy (PVR) and TetraLens for post-operative pain. Montoya focuses on the lead asset, TetraLens, for the majority of the presentation.
Both lenses are composed of methafilcon-A and include a drug polymer ring–Tetralens contains the equivalent of less than 5 drops of 1% tetracaine. In both designs, the ring is in the periphery and encapsulated within the hydrogel lens for sustained release.
TetraLens is intended for pain management following corneal cross-linking, cataract surgery, PRK/LASEK, or similar procedures. In the first-in-human trial, EL pain-free ophthalmic surgery (PFOS), 20 post-PRK patients used the TetraLens bandage lens in one eye and a standard bandage in the fellow eye. Surgeries on each eye were done a week apart to isolate pain measurements, and pain and comfort were measured every hour for the first 8 hours and continued through days 1-6. The study used the Ocular Pain Assessment Survey (OPAS) to measure pain.
At day 6, all TetraLenses were centered and comfortable, according to participants. The study data indicates that all eyes using TetraLens as a bandage were pain-free following PRK surgery.
In 2023, TherOptix intends to launch series A to fund an IND submission for TetraLens. They also plan to expand market research and file patents to extend intellectual property rights.
Drug-eluting bandage lenses are a hot topic, as evidenced by the back-to-back presentations on the tech. Glint Pharmaceuticals has received IND acceptance from the FDA for their antibiotic drug delivery contact lens, ACL5. The phase 3 clinical trial is expected to begin in Q2 2023 and will investigate safety, tolerability, pharmacokinetics, and infection-fighting properties in patients wearing the drug-eluting contact lenses.
ACL5 is a lens soaked in 5 mg/ml drug solution, which includes moxifloxacin, for the treatment of corneal infection. The topical anti-infective is indicated for the treatment of bacterial conjunctivitis caused by bacterial organisms. Over several days, moxifloxacin is released via the lens to treat bacterial infection and corneal damage.
The targeted- and sustained-release has been used on over 40 patients with no adverse events reported to date. The bandage lens is worn for up to 48 hours and was reported to be comfortable for patients, even during sleep.
The trial is planned to launch in Q2 2023 with topline results expected in late 2023.
Large eye drops waste product and may cause more irritation than smaller drops, Mackenzie Andrews states. The Nanodropper adapter is a simple solution.
The Nanodropper is designed for microvolume delivery of eye drops. Small eye drops are more efficacious and safer than large eye drops, as more of the drop is absorbed by the eye and is not wasted when the patient blinks. This saves product, which is advantageous for patients who pay for the drops. The typical eye dropper releases 40 microliters per drop; the Nanodropper reduces this to 10.2 microliters per drop.
The Nanodropper adapter is compatible with 90% of eye dropper bottles; the smaller cap is screwed on top of the original dropper. The easy-to-use interface makes it attractive to patients who don’t want to complicate their eye care routine further.
Aldeyra Therapeutics can boast of 2 drugs under investigation by the FDA at the time of writing, which is why Todd Brady, MD, PhD, tells the audience from the top that no claims will be made in his presentation. Instead, he provides a brief overview of Aldeyra’s lead candidates, ADX-629–and oral drug for the treatment of atopic dermatitis, idiopathic nephrotic syndrome, Sjogren syndrome, and moderate alcohol-assisted hepatitis–and ADX-2191–an intravitreal injection for the treatment of primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and retinitis pigmentosa.
The FDA has accepted a New Drug Application (NDA) for ADX-2191 and has set a PDUFA date of June 21, 2023. Primary vitreoretinal lymphoma, a rare but serious cancer, has no FDA-approved treatment.
As for ADX-629, positive topline results of the 12-month safety clinical trial were released at the end of February. More than 2,300 patients have been tested, and no safety concerns have been identified. The detailed results are expected to be presented at an upcoming major meeting that has not yet been identified. The PDUFA date is set for November 23, 2023.