The dry eye drug Miebo (perfluorohexyloctane ophthalmic solution) from Bausch + Lomb and Novaliq is now available in the United States. Approved by the FDA in May, it’s touted as the first and only dry eye treatment that targets tear evaporation.

LKC Technologies has released a report on diabetic retinopathy (DR) to help simplify and standardize DR assessment and management. Titled “Modern Fundamentals of Diabetic Retinopathy Management in Optometry,” the report was developed by members of a 14-member optometric task force.

“There is a dire need for an elevated protocol to guide patient care in DR,” Jeffry Gerson, OD, of Grin Eye Care in Olathe, Kansas, said in a statement. “The sad reality is that the complexity of this disease and the subjectivity of many of our tests can lead to errors and vision loss.” [Get the Report]

Heidelberg Engineering, a UK-based eye care technology company, is partnering with Orbis, an international nonprofit dedicated to preventing and treating avoidable blindness. Heidelberg will fund teaching opportunities and research; specifically, training eye care professionals around the world via Cybersight (Orbis’ telemedicine and e-learning platform). Heidelberg will also fund Orbis’ research into retinoblastoma, a rare retinal cancer that most commonly affects children under age five years.

The United States Patent and Trademark Office (USPTO) has issued a US patent to Stuart Therapeutics. The patent claims support the company’s PolyCol platform of Collagen Mimetic Peptide (CMP) therapeutic compounds. PolyCol is a tissue reparative platform used in its products in development for dry eye disease and glaucoma, among others.

Opus Genetics dosed its first patient in a Phase I/II trial of OPGx-LCA5, a gene therapy developed to treat a form of Leber congenital amaurosis (LCA). The product is an adeno-associated virus 8 (AAV8) vector designed to deliver a functional LCA5 gene to the outer retina in patients with LCA resulting from biallelic mutations in the LCA5 gene.

Final data from Alcon’s Vivity Registry Study of more than 900 cataract patients produced encouraging results: Evaluating real-world patient experiences for up to 12 months post cataract surgery with implantation of either AcrySof IQ Vivity or AcrySof IQ Vivity Toric presbyopia- correcting intraocular lens, about 75% of patients reported no difficulty with their sight for everyday life activities. Most (92%) said they were satisfied with their sight, and more than 91% reported no halos, glares, or starbursts.

CVS Health, Walgreens Boots Alliance, Boiron, and five other companies received warning letters from the FDA this week for manufacturing or marketing unapproved ophthalmic products. The products at issue are drops illegally marketed to treat conjunctivitis (pink eye), cataracts, glaucoma, among other conditions. Some of the products are labeled to contain silver, which can cause problems with long-term use. Read the announcement and review the warning letters here.

Novartis has discontinued clinical development of GT005, a one-time gene therapy for geographic atrophy. An Independent Data Monitoring Committee concluded that overall data from GT005’s Phase II study “did not support continuation of the development program.” Novartis acquired GT005 as part of its acquisition of Gyroscope Therapeutics in 2021.

A study recently published in BMJ Oncology concluded that short-term use of immunosuppressant medications to control noninfectious ocular inflammatory diseases was not associated with an increased risk of cancer.

“When we got these results, I was reassured, and I hope patients will be, too,” said lead author Jeanine Buchanich, PhD, Associate Dean for Research and Associate Professor of Biostatistics at University of Pittsburgh’s Pitt School of Public Health. “Immunosuppressants are widely used and transformative for care of patients with inflammatory diseases, but the potential concern that they carry a cancer risk has forced people to make difficult decisions without enough information. Alleviating that concern with use for inflammatory diseases will help people make the treatment decision that’s right for them.” Researchers from Mass Eye and Ear also contributed to the study. [Read the Full Study]

Neurophth Therapeutics reports that the Australian Therapeutic Goods Administration registered and approved NFS-05, a therapy developed to treat autosomal dominant optic atrophy. There are no other treatments available for this inherited neuropathy.

As part of a Phase III clinical trial, ophthalmologists at UC Davis Health in Davis, California, used an experimental gene therapy to treat a patient with wet age-related macular degeneration (AMD). The drug ABBV-RGX-314 from Regenxbio, is being tested as a one-time therapy for wet AMD and diabetic retinopathy. Review study details by using NCT05407636.

The FDA declined to approve Outlook Therapeutics’ Biologics License Application (BLA) for ONS-5010 (Lytenava), an investigational ophthalmic formulation of bevacizumab intended to treat wet AMD. The reason stemmed from “several CMC [chemistry, manufacturing, and controls] issues, open observations from preapproval manufacturing inspections, and a lack of substantial evidence,” according to a company statement. If approved, Lytenava would give physicians an alternative to off-label use of repackaged oncologic IV bevacizumab.

The first patient has been dosed in Atsena Therapeutics’ Phase I/II clinical trial for ATSN-201, a subretinal injection developed to treat X-linked retinoschisis. Review study details by using NCT05878860.

Apellis updated investors and the public on the retinal vasculitis cases reported among patients using the recently approved geographic atrophy (GA) drug, Syfovre. The company blamed the events on “internal structural variations” identified in the specific 19-gauge x 1½ inch filter needle included in certain injection kits. A causal relationship between the needles and the retinal vasculitis has not been established, however.

Apellis recommends physicians stop using the 19-gauge needles and use injection kits with 18-gauge filter needles. These kits are already in distribution. According to a statement, the company estimates events of retinal vasculitis are still “very rare at an estimated real-world rate of 0.01 percent.

Apellis shares have responded well to the news, rising from $30.76 to $42.82 in one day.

Biomarkers found via retinal imaging may indicate signs of Parkinson’s disease up to seven years before the disease manifests clinically. Researchers from Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, conducted a large study on retinal imaging and Parkinson’s disease and found individuals with Parkinson’s disease have reduced ganglion cell-inner plexiform layer and inner nuclear layer thickness. [Read the Full Study]

Are your patients asking for blue-light—filtering glasses? They may want to save their money. A recent review of 17 clinical trials found blue-light lenses found no evidence of reduced eye strain, protection against retinal damage, or improvement of sleep. [Read the Abstract]

Days after Regeneron and Bayer announced positive, 48-week data from its pivotal PULSAR trial investigating an 8 mg dose of aflibercept (Eylea HD), the FDA approved the higher-dose for wet age-related macular degeneration (AMD), diabetic macular edema (DME) and diabetic retinopathy (DR). The FDA declined to approve aflibercept 8 mg about a month ago due to “inspection findings at a third-party filler.” According to an article in Fierce Pharma, Regeneron “provided proposed corrective and preventative actions to address these observations.”

The first patient has been dosed in Neurophth’s Phase I/II clinical trial of NFS-02 in patients with Leber hereditary optic neuropathy caused by ND1 mutation. A team led by Professors Jia Qu and Rong Zhou from the Eye Hospital of Wenzhou Medical University in China is overseeing the patient’s treatment.

Amber Ophthalmics enrolled its first patient in its Phase II/III NEXPEDE-1 trial to evaluate two concentrations of Nexagon (lufepirsen ophthalmic gel) for the treatment of persistent corneal epithelial defects (PCED). Mark S. Gorovoy, MD, enrolled the inaugural patient. For study details, see NCT05966493.

The European Medicines Agency (EMA) approved ViGeneron’s clinical trial application for VG901, a gene therapy designed to treat CNGA1-associated retinitis pigmentosa (RP). The therapy uses an adeno-associated virus vector to deliver the therapy via intravitreal injection.

The EMA also accepted Iveric Bio’s marketing authorization application (MAA) for potential approval of avacincaptad pegol (Izervay) for geographic atrophy (GA) treatment. With acceptance of the MAA, the EMA will start its review for potential approval.

Nonprofit Prevent Blindness has launched a new advocacy website: Advocacy.PreventBlindness.org. Check it out for policy information, skill-building resources, representative information, and more.

Staar Surgical has teamed with Tennessee Titans quarterback Will Levis to raise awareness for Staar’s EVO Implantable Collamer Lenses (EVO ICL). The lenses are designed to correct myopia and myopia with astigmatism. “The ability to wake up with sharp, clear vision has been a game-changer,” said Levis in a press release. The Staar Surgical team talk about the company’s celebrity campaigns on a recent OIS podcast. [Listen Here]

With wildfires burning everywhere from Maui to Quebec this year, wildfire smoke has affected a large portion of the North American population. Because of this, eye health experts have raised concern over the long-term impact of this toxic smoke. Recent studies have linked wildfire smoke to ocular surface disease, though results are inconclusive. For patients who present with itchy, gritty, red, watery, irritated eyes during a period of low air quality, consider these tips from VSP Vision. Check wildfire activity using AirNow’s Fire and Smoke map.

Euclid Vision Cofounder George Glady has passed away, the company announced this week. Glady helped develop the company’s Ortho-K contact lenses, which are designed to reshape the cornea in people with myopia.

And in case you haven’t heard, Precision Lens owner Paul Ehlen died in a plane crash in Montana in late June. His plane, a vintage World War II aircraft, malfunctioned on takeoff. “Paul was an innovative and courageous man, and his entrepreneurial spirit and dedication to helping others will continue,” Precision stated. “Above all else, Paul was a family man, and our thoughts and prayers are with his wife and children whom he loved so dearly.”

A month prior, Precision Lens, which provides surgical products and intraocular lenses, was hit with a $487 million judgment in a False Claims Act and Anti-Kickback Statute case. According to an article in Mass Device, the company plans to appeal.

The FDA has accepted the new drug application (NDA) for bromfenac ophthalmic solution 0.09% for the treatment of postoperative inflammation and pain. The product is the generic equivalent of Bausch + Lomb’s Bromday and was developed by Lupin, a pharmaceutical company based in Mumbai, India. Lupin will also manufacture the drug if approved.

Sandoz is making progress on its aflibercept biosimilar. Results from its Phase III study showed therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the aflibercept biosimilar and Eylea (aflibercept 2 mg; Regeneron). Sandoz plans to file for U.S. and EU regulatory approval in the coming months.

Rayner completed the first two implants in two pivotal market access studies in the U.S. and China for the RayOne EMV Toric IOL. The inaugural U.S. implant took place at Vance Thompson Vision in Sioux Falls, South Dakota, last week. The results of the study will support a premarket approval (PMA) submission to the FDA. The second implant took place in June at The Peking University Hospital, and the results will support approval in that country.

Regeneron and Bayer announced positive, two-year (96 weeks), topline data from its pivotal PULSAR trial investigating Eylea (aflibercept 8 mg) in patients with wet age-related macular degeneration (AMD). The study demonstrated that most patients were able to maintain or further extend dosing intervals. Specifically, 88% were on a ≥12-week dosing interval at the end of two years, and 78% maintained ≥12-week dosing intervals throughout the two-year study period, compared to 83% throughout the first year of study (48 weeks).

Topline results from Oculis’ Phase III trial for OCS-01 eye drops show that the drop met its primary endpoints: absence of inflammation at day 15 and the absence of pain at day 4. It was also well tolerated. If approved, the product will be the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery. The company also announced that it has enrolled the first patient in a study to evaluate OCS-01 for the treatment of cystoid macular edema (CME).

Iveric Bio, now part of Astellas, closed out last week by announcing the FDA’s approval of what is now called Izervay (avacincaptad pegol intravitreal solution). It is the second approved treatment for geographic atrophy. Astellas/Iveric says it’s the “only approved GA treatment with a statistically significant reduction (P < .01) in the rate of GA progression at the 12-month primary endpoint across two phase 3 clinical trials.” It is expected to be available in 2-3 weeks.

Nanoscope Therapeutics announced six-month results from its Phase II clinical trial for MCO-010, for patients with Stargardt disease. Highlights include clinically meaningful improvements in best-corrected visual acuity, an approximate 3 dB gain in mean sensitivity, and no serious adverse events.

The latest from Apellis on the safety of Syfovre: To date, the company is aware of seven confirmed events of retinal vasculitis. It is also evaluating an eighth case. Apellis reported no manufacturing-related issues, and no quality issues were identified. It will continue to work with the retina community and share updates as it gets them.

The FDA cleared the investigational new drug (IND) application for a Phase I/IIa clinical trial for SKG0106 from Skyline Therapeutics. SKG0106 is a gene therapy designed to treat neovascular AMD.

Okyo Pharma, in partnership with Tufts Medical Center, in Boston, will conduct an open-label clinical trial to evaluate OK-101 in patients with neuropathic corneal pain. OK-101 is also being investigated in a Phase II trial to treat dry eye disease. The product is a lipid conjugated chemerin peptide agonist of the ChemR23 G protein-coupled receptor that is typically found on immune cells of the eye responsible for the inflammatory response.

OcuTerra Therapeutics reports completing enrollment in the Phase II DR:EAM clinical trial evaluating topical OTT166 eye drops in adults with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) with minimal vision loss. DR:EAM stands for Diabetic Retinopathy: Early Active Management. The trial enrolled 225 adult patients who were randomly assigned one of two doses of OTT166 or to one of two control groups receiving vehicle. OTT166 is a small-molecule integrin inhibitor. [For further details: https://www.ocuterratx.com/for-physicians]

Kodiak Sciences has scrapped its investigative program for tarcocimab tedromer, an anti-vascular endothelial growth factor (VEGF) biopolymer conjugate, after reporting disappointing topline results from two of three Phase III studies. The DAYLIGHT trial (n=557) in neovascular, or wet, age-related macular degeneration (nAMD), met its primary endpoint of noninferiority, compared to monthly aflibercept (Eylea, Regeneron Pharmaceuticals) and demonstrated tarcocimab was safe and well tolerated with a low rate of intraocular inflammation. The GLEAM and GLIMMER studies (n=460 and n=457) in diabetic macular edema (DME), comparator-controlled studies with aflibercept, failed to meet their primary efficacy endpoints of achieving noninferior visual acuity gains. Additionally, an unexpected increase in cataracts was observed over time in the tarcocimab arms of both trials.

Biocon Biologics got a favorable opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of its aflibercept biosimilar, Yesafili. The potential indications match those of the reference product, Eylea: nAMD, macular edema secondary to retinal vein occlusion, DME and myopic choroidal neovascularization. The European Commission will consider the CHMP opinion, with a decision on approval expected by the end of September.

The SAHARA trial met its primary six-month endpoint of achieving superiority of interventional eyelid procedures enabled by TearCare eye drops over Restasis (Allergan/AbbVie), trial sponsor Sight Sciences reported.  The trial demonstrated an improvement of tear break-up time (TBUT) with TearCare, a key measure of aqueous retention, tear stability and the tear film’s ability to protect the ocular surface. SAHARA also showed that procedures enabled by TearCare were noninferior to Restasis eyedrops in Ocular Surface Disease Index (OSDI), the co-primary six-month endpoint.

The American Society of Retina Specialists has sent an e-mail to members informing them that it has received reports of intraocular inflammation, including six cases of vision-threatening occlusive retinal vasculitis, following injection of Syfovre (pegcetacoplan) into the eye. The notification came almost five months to the day after the Food and Drug Administration approved pegcetacoplan as the first intravitreal treatment for GA, an advanced form of dry age-related macular degeneration (AMD). The e-mail, issued as an update by the ASRS’ Research and Safety and Therapeutics (ReST) committee, noted that the reported events were observed between 7 and 13 days after injection. No specific drug lots have been implicated. “The etiology of these events is unclear, and outcomes in these patients are still evolving,” the e-mail stated. In a statement, Apellis Pharmaceuticals noted that the rate of retinal vasculitis in real-world use was about 0.01% per injection. “We are in the process of thoroughly investigating all cases with external experts, including real-world procedure technique and potential risk factors,” the statement

Clearside Biomedical initiated enrollment and dosing in its Phase IIb ODYSSEY trial of CLS-AX, an injectable suspension of the tyrosine kinase inhibitor axitinib for the treatment of neovascular, or wet, age-related macular degeneration (AMD). CLS-AX is injected into the suprachoroidal space of the eye using Clearside’s patented SCS Microinjector, which provides targeted delivery to the disease site. Topline data are expected in the Q3 2024.

Belite Bio received approval from the Taiwan Food and Drug Administration to initiate the Phase III PHOENIX clinical trial of Tinlarebant for geographic atrophy (GA) associated with dry AMD. The multicenter, double-masked, placebo-controlled, randomized, fixed-dose clinical study has been underway in the US. It will enroll approximately 430 patients with a 2:1 randomization of tinlarebant:placebo. Formerly known as LBS-008, Tinlarebant is a novel oral therapy that targets toxins in the eye that cause Stargardt disease and contribute to GA.

The FDA strongly encourages clinical trial sponsors to recruit patient populations that mimic the population of individuals who have that disease. A study published this week in Nature found that minority groups are consistently underrepresented in glaucoma and retina clinical trials. That is concerning, given primary open-angle glaucoma’s prevalence is higher among older Hispanic or Latino individuals (18%) and Black individuals (15%) than among White adults (7%) according to NIH data. Read the full study for details (subscription required).

Cognition Therapeutics dosed its first patient in its Phase II MAGNIFY study of CT1812, an experimental oral geographic atrophy (GA) treatment. The company intends to enroll 246 adult patients diagnosed with dry age-related macular degeneration (AMD) with measurable GA. Erie Retinal Surgery in Erie, PA, enrolled the first participant.

Viridian Therapeutics announced positive topline preliminary data from its Phase I/II trial of VRDN-001, a drug used to treat thyroid eye disease (TED). According to investigator Kimberly Cockerham, MD, patients in the 10 mg/kg and 3 mg/kg dose cohorts experienced reductions in proptosis as well as improvements in their clinical activity scores after receiving two infusions of VRDN-001.

Nacuity Pharmaceuticals added another site to its Phase I/II clinical trial for NPI-002, a proprietary antioxidant molecule delivered via a sustained-release intravitreal implant, developed to delay cataract progression in patients undergoing vitrectomy. The trial is already underway at the existing site: The Royal Adelaide Hospital in Adelaide, South Australia.

Upon his return to Bausch + Lomb, CEO Brent Saunders made a decidedly Brent Saunders move when he decided to acquire Xiidra and other assets from Novartis (see Friday’s newsletter for more details if you haven’t seen them already). With this deal, “B+L now owns the most complete and comprehensive portfolio of dry eye disease medications in eye care,” says Darrell White, MD, in an editorial for Healio. [Full Story]

RVL Pharmaceuticals has launched e-commerce platform called ELEVATE. ELEVATE enables providers and patients to efficiently purchase RVL products. Features included auto-refills, subscription-based pricing, home delivery, and an easy online checkout process. To see it in action visit the RVL website.

Mount Sinai’s Icahn School of Medicine recently launched the Center for Ophthalmic Artificial Intelligence and Human Health, one of the few research centers of its kind in the US. The Center aims to advance AI in ophthalmology in multiple ways. Partnering with the Windreich Department of Artificial Intelligence and Human Health, the Center will explore AI-based diagnostic care. According to a company press release, the Center also hopes to help better predict cardiovascular health, as research has shown AI-guided retinal imaging can reveal cardiovascular risk factor. [Learn More]

Will our vision get worse as the world gets hotter? According to a recent study, that could be the case. A team of researchers at University of Toronto found that adults aged 65 years and older who lived in countries with an average temperature of 60 degrees or above had a 44% higher risk of severe vision impairment than did those who lived in a country with a 50 degree or lower average temperature. While the study did not determine the cause, the researchers suspect increased ultraviolet light exposure, air pollution, infections, and folic acid degradation and potential culprits. [Read the Study]

Salvat Laboratories initiated a new study in Europe to test its corticosteroid in children up to age three years who have cataracts. The trial examines the safety and efficacy of SVT-15473 clobetasol to treat inflammation and pain in pediatric patients after cataract surgery. The study is part of an FDA approval process. It will include 60 patients. The study has enrolled four patients to date.

The FDA cleared Skyline Therapeutics’s Investigational New Drug (IND) application for Phase I/IIa clinical trials for SKG0106, a one-time intravitreally delivered recombinant AAV gene therapy for the treatment of neovascular age-related macular degeneration (nAMD). The company plans to launch its Phase I trial “soon” according to a company press release.

Formycon and Klinge Biopharma have submitted a biologics license application for FYB203, an Eyelea biosimilar, to the FDA. “With FYB203 we are going to address an important as well as growing market for the treatment of severe retinal diseases and contribute to alternative and cost-effective therapeutic options,” said Formycon CEO Stefan Glombitza, PhD, in a press release.

At the 9th Congress of the European Academy of Neurology (EAN) in Budapest this week, Horizon Therapeutics presented new data from its Phase III trial of Uplinza (inebilizumab-cdon). The data show reduced formation of subclinical (asymptomatic) transverse myelitis lesions in people with neuromyelitis optica spectrum disorder (NMOSD). Transverse myelitis lesions typically occur in people with infections or autoimmune diseases.

“This analysis offers new insights into the significance of subclinical MRI findings on the spinal cord as a potential signal of future attacks, adding to the growing list of tools available for physicians to better monitor their patients,” said Friedemann Paul, study author and Group Leader of the Clinical Neuroimmunology Department of NeuroCure Clinical Research Centre at the Charité, Berlin, Germany, in a news release.

Intergalactic Therapeutics released positive preclinical data from IG-002, its lead program for the treatment of ABCA4-related retinopathies. The gene therapy safely achieved durable six-month expression of human ABCA4 in non-human primate retinas. ABCA4 currently has no approved treatments.

Data show physicians can perform office-based lens surgery safely, with adverse event rates similar to those of published literature according to a study published by iOR Partners Partners in the Journal of Cataract & Refractive Surgery. The study analyzed records of more than 18,000 consecutive patients who underwent office-based lens surgery for visually significant cataract, refractive lens exchange (RLE), or phakic IOL implantation. Rates of postoperative endophthalmitis, toxic anterior segment syndrome (TASS), and corneal edema were 0.028%, 0.022%, and 0.027%, respectively. Unplanned vitrectomy was performed in 0.177% of patients. [Read the Study]

EyeCare Partners has launched the Advanced Comprehensive Ophthalmology Fellowship (ACOF). The one-year fellowship provides comprehensive training to residency graduates on diagnostic and therapeutic techniques, surgical procedures, and clinical research, among other topics. The fellowship program starts in fall 2024 and applications are open until August 31, 2023. [Apply Here]

20/20 Onsite earned a Site Readiness Certification from Precision Vision Clinical Trial Solutions, a division of Precision Vision. 20/20 Onsite is the first mobile clinic to earn the certification, giving clinical trial sponsors a new way to expand clinical trial participation. [Learn More]

Elios Vision has completed enrollment for its pivotal trial for its Elios excimer laser procedure in combination with cataract surgery. The trial recruited over 300 patients with mild to moderate glaucoma. The procedure has already received a CE mark.

Molecure filed an Investigational New Drug application with the FDA for OATD-01, a drug developed to treat sarcoidosis. If the FDA approves the NDA, Molecure will begin a Phase II trial for the chitotriosidase (CHIT1) inhibitor. Inhibition of CHIT1 by OATD‑01 has been shown to reduce inflammation and fibrosis, the company states.

The Brazilian Health Regulatory Agency (ANVISA) has approved Tepezza for the treatment of thyroid eye disease (TED). Tepezza, from Horizon Therapeutics, is the first medicine approved in Brazil for TED the company stated. The product received FDA approval in 2020, and regulatory approval in Japan appears on the horizon (pun intended).

Visgenx announced positive topline data from a preclinical study of VGX-0111 for dry age-related macular degeneration (AMD). The study, in nonhuman primates, successfully demonstrated three parameters: VGX-0111 expresses in the target tissues, causes an increase in certain very long-chain polyunsaturated fatty acids, and is well tolerated.

Intergalactic Therapeutics also announced positive results from its nonviral gene therapy platform, IG-002, which addresses retinopathies related to the ABCA-4 gene. The platform safely achieved durable 6-month expression of human ABCA-4 in non-human primate retinas with a single subretinal administration.

Nonprofit eye bank Eversight is collaborating with Donor Network of Arizona, the state’s federally designated organ procurement organization, to provide eye banking services in the Grand Canyon state. The partnership takes effect July 1. [Learn More About Eversight]

Glaucoma surgeons take note: Cigna recently updated its Glaucoma Surgical Procedure policy to cover both ab interno canaloplasty and goniotomy (trabeculotomy) procedures for the treatment of open-angle glaucoma effective June 15, 2023. Sight Sciences announced the update because its OMNI Surgical System is FDA-cleared for canaloplasty followed by trabeculotomy to reduce intraocular pressure (IOP) in adult patients with primary open-angle glaucoma. [Review the Policy]

Horizon Therapeutics has published a new analysis from its N-MOmentum clinical trial of Uplinza. The study described an adjudication process that could improve clinical care decision-making in neuromyelitis optica spectrum disorder (NMOSD) through more accurate and consistent assessment of disease-related attacks. You can read about the approach in Multiple Sclerosis Journal.

Marinomed Biotech will launch a new Carragelose eye drop product (MAM-1001-3) in Austria in the first half of 2024, the India-based company announced. Carragelose is a virus-blocking compound; however, the company’s announcement said MAM-1001-3 is intended for dry eye relief. Learn more about Carragelose.

A study in JAMA Ophthalmology found “neighborhood-level social risk factors,” such as inequity, housing burden, and lack of transportation, may contribute to health disparities in microbial keratitis (MK) disease presentation. The findings suggest these neighborhood-level social determinants of health (SDOH) impact health outcomes much like individual-level SDOH. Read the Full Study (subscription required).

Curious about reimbursement for Harrow’s Iheezo? In this video, William Wiley, MD, explains the benefits of the FDA-approved ocular anesthetic, how he’s used it in his practice, and the way it’s reimbursed.

Last but by far not least, ophthalmologist (and OIS podcast host) Ehsan Sadri, MD, recaps a panel on the future of eye care that was part of Octane’s recent Ophthalmology Tech Forum. Companies such as Orasis Pharmaceuticals, Visus Therapeutics, and Johnson & Johnson Vision got a mention. [Watch the Video]

The FDA responded to Aldeyra Therapeutics’s New Drug Application for ADX-2191 (methotrexate for injection, USP) with a rejection. The agency found insufficient evidence of effectiveness due to “a lack of adequate and well-controlled investigations” in the literature-based NDA submission. Aldeyra stated in a company press release that it did not conduct clinical trials of the drug—developed to treat primary vitreoretinal lymphoma (PVRL)—per prior discussions with the FDA.

“While we appreciate the FDA’s position with respect to providing evidence from adequate and controlled trials, we do not currently believe that randomized clinical trials of ADX-2191 in PVRL, a rare and fatal cancer with no approved therapy, are feasible,” Aldeyra President and CEO Todd Brady, MD, PhD, responded. “Given the current shortage of methotrexate, the lack of approved therapy for PVRL, and the desire to avoid potential safety risks associated with ocular injection of compounded formulations, we look forward to discussing with the FDA the potential for making ADX-2191 available to PVRL patients under an Expanded Access Program.”

In more positive news, iStar Medical will present three-year interim data from its STAR-GLOBAL trial at the 10th World Glaucoma Congress (WGC) on June 29. The trial evaluates the MINIject, a minimally invasive glaucoma surgery implant. The device has already been implanted in over 1,000 patients across Europe and the UK.

Bausch + Lomb has launched a new eye health supplement: the PreserVision AREDS 2 Formula soft gels plus coenzyme Q10 (CoQ10). The company says it’s “the only eye vitamin that combines the exact nutrient formula recommended by the National Eye Institute (NEI) to help reduce the risk of moderate to advanced age-related macular degeneration (AMD) progression in AMD patients with CoQ10 to help support heart health.” [Check It Out]

Alcon has been busy gathering data. It now has results from the Alcon Eye On Cataract Survey, a global survey among 7,331 cataract surgery patients aged 50 and over. One finding: memory, mobility, and vision are the three most important qualities of aging among almost all respondents (83-84 %). [Get More Survey Results]

Looking for a summer read? Take a look at the Centre for Ocular Research & Education (CORE)’s latest issue of Contact Lens Update. Issue 72 focuses on corneal ectatic disorders.

The FDA granted 510 (k) clearance to the iHealthScreen iPredict Eye Screening System, the company announced recently. iPredict is an AI-enabled tool that screens for age-related macular degeneration (AMD) in patients aged 50 and older. The screening takes five minutes and provides results within 60 seconds.

The FDA also gave 510 (k) clearance to EverPatch from CorNeat Vision. EverPatch is a synthetic, non-degradable tissue-integrating matrix for use in ophthalmic surgeries. It’s designed to address the critical needs of ocular surgeons, providing a sterile and non-degradable solution for surgical patients. CorNeat will launch the product in a few ophthalmic centers in Q3.

EyeBio has launched its Phase Ib/II clinical trial to evaluate the safety and preliminary efficacy of intravitreal Restoret (EYE103) in patients with diabetic macular edema (DME) and neovascular AMD. Restoret is an investigational tri-specific antibody that acts as an agonist of the Wnt signaling pathway. It is designed to resolve residual fluid in the retina and to improve visual acuity in patients with DME and neurovascular AMD.

Sky Bioscience dosed its final patient in the final multiple ascending dose (MAD) arm of its Phase I trial evaluating the safety of SBI-100 Ophthalmic Emulsion in patients with glaucoma. The topical cannabinoid receptor type 1 (CB1R) agonist was well tolerated with only mild and moderate adverse events.

Ocular Therapeutix has topline data from its Phase I clinical trial evaluating OTX-TK1, an axitinib intravitreal hydrogel implant, for the treatment of wet AMD. Data demonstrated maintenance of controlled wet AMD subjects comparable to aflibercept injections every eight weeks with a single administration of OTX-TKI. Four subjects received rescue therapy for the first time at Month 12. No serious drug-related ocular or systemic adverse events were observed.

MediPrint Ophthalmics completed its SIGHT-2 dose-finding Phase IIb Group 1 (low-dose) study for its proprietary drug-eluting contact lens for glaucoma, LL-BMT1. The group that received LL-BMT1 achieved IOP reduction of about 5.5 mm Hg, comparable to the reference treatment. MediPrint will study the lens in two other groups for this trial.

Stealth BioTherapeutics reported a positive end-of-phase-2 meeting with the FDA about its lead drug candidate, elamipretide, developed to treat dry AMD. The FDA's meeting minutes confirmed ellipsoid zone (EZ) attenuation as an approvable endpoint in dry AMD, giving the company confidence to move forward.

________

*Ocular Therapeutix and Stealth BioTherapeutics are set to showcase their latest advancements at the upcoming Retina Innovation Summit. Register here and stay updated on the cutting-edge developments shaping the field of retinal health.

Apple’s next operating system update will include new features designed to protect eye health. Apple Watch will measure time users spend in daylight so users can spend the recommended 80 to 120 minutes outdoors. The iPhone and iPad will nudge users if they keep the device too close to their face for too long, potentially reducing risk of eye strain in adults and myopia in children. Look for the new OS this fall. [See iOS 17]

GameSquare Holdings also supports healthy screen habits. It’s teamed up with Swiss vision care start-up Vivior to execute a comprehensive marketing campaign to talk about the negative effects of digital eye strain. A rewards program will help incentivize gamers to adopt healthier habits.

AOS (Advanced Ophthalmic Systems) launched a new remote visual acuity software platform. The update is designed to measure and calculate precise and reliable visual acuity test scores and offers the same level of security and compliance as previous versions. It’s available as both a stand-alone product and as part of an AOS subscription. [See the Website]

Biotrue Hydration Boost Contact Lens Rehydrating drops from Bausch + Lomb are now available at retailers throughout the United States. The preservative-free drops help combat dryness from contact lens–wearing. Relatedly, the company also launched the Infuse Multifocal silicone hydrogel (SiHy) daily disposable contact lenses.

The FDA approved Novaliq’s Vevye (cyclosporine ophthalmic solution .1%, formerly called CyclASol) for the treatment of dry eye disease. The preservative-free, oil-free drop delivered impressive results in clinical trials, with significant improvements in tCFS and dryness score at 29 days and corneal staining score improvements after two weeks. The announcement follows the approval of Bausch + Lomb/Novaliq’s Miebo last month.

Horizon Therapeutics published new data from its Phase III pivotal trial of Uplizna. The study identified important biomarker trends associated with neuromyelitis optica spectrum disorder (NMOSD, aka Devic disease) attacks. Look for the study in The Journal of Neurology, Neurosurgery and Psychiatry.

Glaukos completed enrollment and randomization in its second Phase III pivotal trial for Epioxa in less than six months. Epioxa is a next-generation corneal cross-linking therapy for the treatment of keratoconus. The first Phase III trial met its primary endpoint. Glaukos plans to submit a New Drug Application (NDA) by the end of 2024.

Eyepoint Pharmaceuticals completed enrollment in its Phase II trial evaluating EYP-1901 as a potential nine-month treatment for moderate to severe non-proliferative diabetic retinopathy (NPDR). The company enrolled 77 patients, exceeding its 60-patient target. It expects to have topline data to report in Q2 2024.

Meanwhile, Clearside Biomedical started enrollment for its Phase IIb trial for CLS-AX (axitinib injectable suspension). It plans to enroll 60 patients with wet AMD within 36 months of screening. The study will compare the efficacy of CLS-AX with aflibercept for 36 weeks.

Aviceda Therapeutics dosed its first patient in its Phase II trial for AVD-104. The intravitreal drug is a novel glycan-coated nanoparticle intended to treat patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Yuyu Pharma announced topline results from its Phase I/II trial of YP-P10 in patients with dry eye disease. Over 12 weeks, the YP-P10 exhibited a positive safety profile and was well-tolerated. Patients reported improved ocular discomfort scores by the sixth visit but no significant reduction in corneal staining scores. Mild adverse events were balanced across study groups.

Eyestem Research submitted an Investigational New Drug (IND) application to the Central Drugs Standards Control Organization, India, to begin its first-in-human trials for Eyecyte RPE. The cell therapy is being developed to treat patients with medium- and late-stage GA secondary to dry AMD.

VivaVision Biotech reports its VVN539 ophthalmic solution met its primary endpoints for the treatment of primary open-angle glaucoma or ocular hypertension in a Phase II study. The treatment was statistically superior to the vehicle at all nine time points over the 21-day study. Next step: a trial comparing VVN539 against a first-line hypotensive drug therapy in a larger patient population.

A team of researchers from Google, Verily Life Sciences, and elsewhere recently published a study that compares the performance of an automated deep learning algorithm with manual grading by ophthalmologists for identifying diabetic retinopathy in retinal fundus photographs. The specificity and sensitivity were quite good, showing promise for use in the clinical setting. Read the full study in JAMA to find out how the researchers trained and validated the model and the results.

A group of eye care companies have joined forces to raise awareness around the negatives associated with preservatives in eye drops and encourage use of preservative-free options. Called the Preservative Freedom Coalition, the organization will focus on awareness, availability, and advocacy. Founding members include Thea Pharma, The Glaucoma Foundation, The Intrepid Eye Society, National Medical Association Ophthalmology Section, and Real World Ophthalmology. Visit the organization’s webpage for details.

HOYA Vision Care has released its MiYOSMART Sun spectacle lenses in both Singapore and Canada. Available in photochromic and polarized options, the spectacles are developed to slow down myopia progression in children while protecting the eyes from the sun.

Recruiting through a pandemic, Nacuity Pharmaceuticals completed enrollment for its SLO-RP Phase I/II clinical trial of NPI-001 The study is designed to assess the safety, tolerability, and efficacy of NPI-001 tablets versus placebo in patients with retinitis pigmentosa (RP) associated with Usher syndrome. The company expects to have efficacy data by the end of the year.

Coave Therapeutics, a gene therapy company headquartered in France, has 12-month results from its Phase I/II trial of CTx-PDE6b, a gene therapy for RP caused by bi-allelic mutations in the PDE6B gene. Doses were well-tolerated in all groups, the company reports; however, the subgroup with less-advanced disease who received a higher dose showed positive efficacy consistently across five endpoints.

Roche Canada has completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for VABYSMO (faricimab injection), indicated for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The company secured a letter of intent from pCPA, which is a critical step in making VABYSMO available in many provinces throughout Canada.

Annexon announced disappointing topline results from its ARCHER Phase II trial of ANX007 in patients with geographic atrophy (GA). The primary endpoint—mean rate of change (slope) in GA lesion area compared to sham at 12 months—did not reach statistical significance. It did, however, demonstrate statistically significant, dose-dependent preservation of visual function. The company plans to engage with the FDA to determine the next step forward. “The ultimate goal for any physician is to preserve vision for our patients for as long as possible,” said investigator Jeffrey Heier, MD, Director of the Retina Service and Retina Research, Ophthalmic Consultants of Boston, in a statement. “The totality of the data on ANX007 from the ARCHER trial are promising, with the demonstrated preservation of functional vision in GA patients, regardless of their lesion location or size. I am encouraged with the overall profile of ANX007 and look forward to its continued development.”

C. Light Technologies received 510(k) clearance from the FDA for Retitrack, its retinal eye movement monitor. The device is designed to offer insight into oculomotor function by using the retina, providing medical professionals with concrete, objective metrics.

iHealthScreen submitted its 510(k) for iPredict, a fully automated artificial intelligence–based software used for early diagnosis of AMD. The tool provides retinal screening and delivers an immediate report of results.

Alimera has completed enrollment for its randomized, controlled, multicenter study designed to generate prospective data for ILUVIEN (fluocinolone acetonide intravitreal implant, 0.19mg) as a baseline therapy in patients diagnosed with DME. The study will compare ILUVIEN, a corticosteroid, with an anti-VEGF therapy. The company expects to share data in 2025.

AiViva Biopharma launched a Phase I trial for AIV007, a broad-spectrum tyrosine kinase inhibitor, targeting the convergence of fibrosis, angiogenesis, and inflammation in patients with wet AMD, and/or diabetic macular edema (DME).

Oculis reported results from stage one of its Phase III DIAMOND trial for OCS-01, an eyedrop designed to treat DME. OCS-01 showed statistically significant improvement in mean best corrected visual acuity ETDRS score from baseline to week six of 7.2 letters, compared with 3.1 letters in those who received vehicle—a results that lasted through week 12.

HanAll Biopharma Co. reported that its Phase III VELOS-3 trial didn’t demonstrate significant improvement in central corneal staining score or in Eye Dryness Score via Visual Analogue Scale at eight weeks. The study evaluated the safety and efficacy of tanfanercept, a novel, topical anti-inflammatory treatment for patients with moderate to severe dry eye disease. The company plans to continue to study tanfanercept, possibly in higher concentrations.

Last week, OIS podcast guest Natasa Jovic of RetinAI talked about the implications of AI for ophthalmologists and the eye care industry at large.

Here’s another take on AI in retina: AI expert Eric Souied, MD, PhD, head of Department of Ophthalmology at the “Hopital Intercommunal de Creteil” in France, shares his thoughts on using deep learning to screen and interpret retinal images to look for retinal lesions that may indicate diabetic retinopathy (DR). He also shares results from a retrospective analysis of 224 patients with DR using deep learning and ultra-widefield imaging. Read the Article.

Responding to the approval of MIEBO (perfluorohexyloctane ophthalmic solution) from Bausch + Lomb/Novaliq, reportedly the first FDA-approved dry eye disease treatment that targets tear evaporation, a few experts gave comments to Ophthalmology Times:

“We were a phase 3 study site and have early experience with perfluorohexyloctane,” said Laura M. Periman, MD, director of Dry Eye Services and Clinical Research, Periman Eye Institute in Seattle, Washington. “With this approval, US doctors now have access to a first-in-class alkane drop as a topical ophthalmic therapeutic for the signs and symptoms of dry eye disease.”

Ernest W. Kornmehl, MD, of Kornmehl Laser Eye Associates, Harvard and Tufts Universities said MIEBO’s advantages include “low volume, surface tension, and viscosity and are amphiphilic.” He added it will take real-world evidence from thousands of patients to know for sure whether MIEBO is a big step forward for dry eye. Thoughts? Read More About MIEBO.

The FDA approved Bausch + Lomb and Novaliq’s MIEBO (perfluorohexyloctane ophthalmic solution; fka NOV03). MIEBO is the first and only FDA-approved treatment for dry eye disease that directly targets tear evaporation.

C. Light Technologies received 510(k) clearance from the FDA for the Retitrack, a monocular, tabletop eye-movement monitor that is intended for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses when viewing a visual stimulus. The company says Retitrack is the first retinal eye-movement monitor cleared for use in the healthcare setting.

Invirsa completed enrollment of its Phase I/IIa clinical trial of a topically administered eyedrop formulation of INV-102 for dry eye disease. The company also received approval from Thailand FDA equivalent to test INV-102 in patients with acute infectious keratoconjunctivitis (AIK).

Glaucoma patients who underwent surgical procedures with the Omni Surgical System from Sight Sciences had a greater average reduction in the use of intraocular pressure-lowering medication, compared to those who had received only minimally invasive glaucoma
procedures or cataract surgery. This is what Sight Sciences found during a 12-month retrospective sub-analysis study analyzing 17,000 records from the American Academy of Ophthalmology’s (AAO) Intelligent Research in Sight (IRIS) Registry. Here's a summary of the study.

The Foundation for the National Institutes of Health (FNIH) has selected eight rare diseases the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC). The consortium’s mission is to help speed the development and delivery of customized gene therapies. Three of the rare diseases selected are in ophthalmology: Congenital Hereditary Endothelial Dystrophy, NPHP5 Retinal Degeneration, and retinitis pigmentosa. [More Info]

The FDA has approved Eyenovia’s MydCombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. According to Eyenovia, the approval represents the first approved, fixed-dose combination of tropicamide and phenylephrine in the United States. It’s also the first approved product that uses Eyenovia’s Optejet device.

On the device side, the ECHO Green Pattern Laser photocoagulator has received both FDA 510(k) clearance and a CE Mark. The ECHO from Norlase is a portable scanning laser photocoagulator that uses MEMS technology.

The FDA accepted Glaukos’s New Drug Application (NDA) for iDose TR (travoprost intraocular implant). iDose TR is designed to continuously deliver therapeutic levels of a proprietary formulation travoprost formulation from within the eye for extended periods of time. It is designed so it can be removed and replaced with a new iDose TR, making it a potential alternative to eye drop treatment. The Prescription Drug User Fee Act (PDUFA) goal date is set for December 22, 2023.

Meanwhile, the FDA accepted Genentech’s supplemental biologics license application (sBLA) for Vabysmo (faricimab-svoa) for macular edema following retinal vein occlusion (RVO) treatment. It was approved for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME) in the U.S. in January 2022.

Formosa Pharmaceuticals and AimMax Therapeutics submitted their NDA for APP13007, a novel aqueous nanosuspension formulation of the corticosteroid clobetasol propionate (0.05%). The product is intended to treat inflammation and pain following ocular surgery.

University of California, Irvine, researchers may have discovered a new drug class aimed at age-related macular degeneration (AMD), diabetic retinopathy (DR), and retinitis pigmentosa (RP). Called Stress Resilience-Enhancing Drugs (SRED), the small molecule intervention enhanced resilience to acute and chronic forms of stress in the degenerating retina, thus preserving tissue structure and function. [Read the Abstract]

It's called an epidemic. Now nine pediatric ophthalmologists are calling on the medical community to recognize myopia as a disease. They advocate for myopia management by delaying onset and slowing its progression. “Myopia progression needs to be treated and controlled, not just corrected for clear vision,” the doctors write in a white paper sponsored by CooperVision. [Read the White Paper]

Enrollment is complete for Endogena Therapeutics’ Phase I/IIa trial of EA-2353, a small molecule drug for the treatment of retinitis pigmentosa (RP). The study enrolled 14 patients, with topline interim data expected in early 2024.

Smartlens has announced positive clinical results for miLens, a noninvasive, electronics-free, soft contact lens for monitoring intraocular pressure (IOP). The study reported a significant and statistically strong correlation between IOP measurements obtained with miLens and those obtained using Goldmann applanation tonometry (GAT) in twenty-five individuals.

Centricity Vision has received 510(k) clearance for the ZEPTOLink IOL Positioning System. The platform integrates the ZEPTO precision pulse capsulotomy technology with any phacoemulsification system, with the potential to streamline cataract surgery.

Nanoscope Therapeutics has announced results from its Phase IIb trial investigating MCO-010 in patients with RP. The results showed 100% of the patients treated with the gene therapy exhibited vision improvement in all tests used.

BVI has completed enrollment in its US Investigational Device Exemption (IDE) clinical study for its latest hydrophobic trifocal intraocular lens, FINEVISION HP. The study enrolled 539 patients, who will now be followed to evaluate safety and performance of the lens.

The FDA has cleared Atsena Therapeutics’ investigational new drug (IND) application for a Phase I/II clinical trial of ATSN-201. The study will examine the safety and efficacy of the gene therapy in patients with X-linked retinoschisis (XLRS).

Visus Therapeutics announced topline data from its pivotal Phase III trial of Brimochol PF, a preservative-free solution designed to treat presbyopia. The product met its primary endpoint: a proportion of subjects achieved > 15 ETDRS1 letter gain in Binocular Near Visual Acuity without a loss of > five letters at distance across all time points through six hours. [Read About the Study]

Harrow has completed the transfer of NDAs for three FDA-approved ophthalmic drugs: ILEVRO, NEVANAC, and MAXIDEX. They represent three of the five ophthalmic products Harrow purchased in January. They’re commercially available now under the Harrow name.

Théa Pharma wants to make clear: the products it acquired from Akorn Operating Company were not affected by Akorn’s recall. The company ceased operations and voluntarily recalled all its products. Théa acquired seven branded ophthalmic products from Akorn, which filed for bankruptcy in February and fired all its employees, which left the company without quality control.