Neurotech Announces Positive Results of MacTel Type 2 Clinical Trial

Neurotech Pharmaceuticals announced positive top-line results in 2 phase 3 clinical trials of its encapsulated cell therapy (ECT) using the NT-501 implant for the treatment of macular telangiectasia (MacTel) type 2. The studies demonstrated the safety and efficacy of the NT-501 implant and the rate of change in ellipsoid zone area loss from baseline through 24 months, with a 56.4% rate of reduction in Protocol A and 29.2% rate of reduction in Protocol B. The rate of change in area loss equates to a change in the rate of photoreceptor loss. These are the first phase 3 clinical validations demonstrating preservation of photoreceptors with a novel ophthalmic neuroprotectant therapy. 

“The positive study results increase the confidence of our innovative ECT platform technology to deliver a novel biological agent over an extended period of time in order to slow the progression of retinal-based diseases,” Neurotech chief medical officer Thomas Aaberg Jr., MD, said in a news release.

Pegcetacoplan Injections Linked to Silicone Oil Droplets and Floaters

Intravitreal injection of pegcetacoplan can be associated with symptomatic silicone oil droplets in the vitreous cavity, according to a study of pegcetacoplan injections using McKesson 1-mL Luer lock syringes. Results of a retrospective review of 55 patients who received intravitreal pegcetacoplan injections administered using a 1-mL McKesson Luer lock syringe indicated that 29% of patients (16 out of 55) developed presumed intravitreal silicone droplets within 2 to 4 weeks of treatment. Of these cases, 88% reported symptomatic floaters described as persistent, while 13% remained asymptomatic. No signs of inflammation, infection, elevated intraocular pressure, or changes in visual acuity among these patients were reported. The researchers noted that their findings support consideration of informing patients of this potential adverse effect, as well as avoiding use of the McKesson syringe, and considering use of silicone-free syringes for pegcetacoplan injections. 

Atsena Reports Positive Results in Leber Congenital Amaurosis Trial

Atsena Therapeutics announced positive 12-month safety and efficacy data from the ongoing phase 1/2 trial of ATSN-101, its gene therapy for the treatment of GUCY2D-associated Leber congenital amaurosis (LCA1). In this study, 15 patients received unilateral subretinal injections of ATSN-101. Three cohorts, with 3 patients in each, were treated with 3 ascending doses. In total, 9 patients received the high dose. At 12 months post-treatment, ATSN-101 had conferred clinically meaningful improvements in vision at the highest dose with no serious treatment-emergent adverse events. 

“The durability of clinically meaningful visual improvements in the absence of serious treatment-related adverse events at the 12-month mark underscore the safety, tolerability, and efficacy of our subretinal gene therapy. We believe the 12-month findings provide solid proof of concept that ATSN-101 will exceed the requirements set by the FDA for ultimate approval,” Atsena Therapeutics chief medical officer Kenji Fujita, MD, said in a news release.

Aviceda Announces Outcomes from Phase 2/3 SIGLEC Trial of AVD-104  

Aviceda announced positive top-line data from part 1 of its phase 2/3 SIGLEC trial for AVD-104, in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Part 1 of the trial included 30 patients who received a single intravitreal injection of AVD-104 and were followed for 3 months. Substantial slowing of GA lesion growth was observed, and most study subjects showed functional improvement that was sustained for the duration of the trial. AVD-104, an intravitreal nanoparticle that modulates inflammatory pathways, was well tolerated in all patients, with no drug-related ocular or systemic serious adverse events detected. Data support the initiation of part 2 of the trial. 

First Patient Dosed in Phase 1 Study of Boehringer Ingelheim Antibody

CDR-Life and Boehringer Ingelheim announced that the first patient has been dosed in the phase 1 trial of BI 771716, a highly specific reduced-size antibody for the treatment of GA. The antibody’s reduced size enables optimized penetration through all retinal layers to the target site driving GA disease pathology. The phase 1 study is evaluating the safety, tolerability, and pharmacokinetics of intravitreal single-rising doses and multiple doses of BI 771716 as a potential treatment for GA. 

“This milestone marks CDR-Life’s emergence as a clinical stage company and underscores the ability of our platform to generate molecules that may one day bring life-changing treatments to patients,” Christian Leisner, PhD, CEO of CDR-Life, said in a news release. 

OliX Announces Positive Results of Phase 1 of OLX10212 Trial for AMD

OliX announced positive results from a phase 1 study evaluating the safety and tolerability of a single intravitreal injection of OLX10212 for the treatment of wet AMD. Fifteen AMD patients received doses of between 100μg/eye/50μL and 950μg/eye/50μL of OLX10212 and were followed for 24 weeks. There were no signs of inflammation or changes of intraocular homeostasis, and no systemic effects were observed. Sporadic ophthalmic adverse effects were transient, mild, and related to the dose administration procedure as expected for intravitreal injections. 

“We are thrilled about the outcome of this first-in-human trial in patients with wet AMD who were treated with OLX10212. The excellent safety and tolerability data, paired with encouraging preliminary BCVA improvement reassure the next steps in this program, and we are confident that OLX10212 and its novel mechanism of action may have potential to provide benefits in the treatment of AMD patients,” OliX CEO Dong Ki Lee, PhD, said in a news release. 

AI Shows Promise as a Screening Tool in Diabetic Eye Disease

A Johns Hopkins Children’s Center study found that autonomous artificial intelligence (AI) diabetic eye exams significantly increased completion rates of screenings designed to prevent diabetic eye diseases. The researchers noted that the AI-driven technology used in the exams may close “care gaps” among racial and ethnic minority youth with diabetes, populations with historically higher rates of diabetic eye diseases, and those with less access to or adherence with regular screening for eye damage. 

In a related study, ChatGPT-4 was used to generate a medical report regarding the risk of diabetic retinopathy (DR) based on clinical and biochemical parameters for diabetes patients who underwent a comprehensive eye examination along with clinical and biochemical assessments. The study concluded that this AI model has potential as a preliminary DR screening tool with further optimization needed for clinical use. 

Gentex Acquires Vision Enhancement Technology Company eSight

Gentex announced that it acquired the vision-enhancement-technologies company eSight, to develop and manufacture the next generation of mobile electronic eyewear for people living with visual impairments. Gentex is a long-time supplier of electro-optical products and is known for supplying major automakers with connected-car technologies and advanced electronic features that optimize driver vision and enhance driving safety. eSight is a wearable assistive-technology company; its eyewear combines a high-definition camera, proprietary algorithms, and powerful processing platform. 

“For many years, our expertise in vision technology has been key in developing automotive solutions that improve driver safety. Our acquisition of eSight is a strategic move to leverage this expertise in the health care industry to address the challenges of vision impairment, furthering our commitment to enhancing visual safety and quality of life,” Gentex chief technology officer Neil Boehm said in a news release. 

Iridex Launches New Retina and Glaucoma Lasers in US Market 

Iridex announced the US launch of its Iridex 532 and Iridex 577 lasers for retina and glaucoma treatment. Both lasers harness multiple treatment modes, including continuous-wave and Iridex’s patented MicroPulse technology, as well as an intuitive touchscreen interface providing a wide range of clinical control options. Among the lasers’ features are the ability to generate detailed treatment reports that can be downloaded to a USB drive, and a new preset management tool enabling customizable selections by procedure and by individual doctor. 

“The launch of the new Iridex 532 and Iridex 577 lasers stands as a testament to our 35-year heritage of providing advanced laser solutions to ophthalmologists worldwide. These innovations mark a pivotal moment for us, blending modern technology with user-centric design to ensure optimized treatments for retinal disorders and glaucoma,” said David Bruce, president and CEO of Iridex Corporation, in a news release. 

LumiThera Initiates EUROLIGHT Study of Photobiomodulation in AMD Patients

LumiThera announced the initiation of the EUROLIGHT EU registry study, which will collect safety and clinical efficacy outcomes from multiple centers that have been treating dry AMD patients. Retrospective data from subjects who underwent photobiomodulation (PBM) treatment every 4 to 6 months for up to 3 years will be collected, and patients will continue to be followed prospectively. The data will be used to support reimbursement in multiple countries and provide clinical information on real-world use of the Valeda Light Delivery System. 

“The ability to collect additional safety and efficacy data from our global experiences will help us continue to study the safety and effectiveness of PBM in early-to-late-stage disease treatment of dry AMD and its effect on the progression of disease and growth of GA lesion rates,” Clark Tedford, PhD, President and CEO, LumiThera, said in a press release. 

Johnson & Johnson Acquires XLRP Gene Therapy From MeiraGTx

Johnson & Johnson, through its Janssen Pharmaceuticals division, has acquired the rights to investigational gene therapy botaretigene sparoparvovec (bota-vec; formerly AAV-RPGR) from MeiraGTx, a clinical stage gene therapy company. The therapy is intended for treatment of patients with the inherited retinal disease X-linked retinitis pigmentosa (XLRP). Bota-vec has already been tested in a phase 1/2 study in adult and pediatric XLRP patients, and a late-stage study completed enrollment this year. Under terms of the deal, MeiraGTx will receive $130 million in upfront and near-term milestone payments, plus an additional $285 million upon first commercial sales of bota-vec in the US and EU and manufacturing technology transfer. 

“The execution of the agreements related to bota-vec for the treatment of XLRP provide us with significant near-term cash as well as cash upon potential approval and commercialization of this important gene therapy, and additional revenue from the commercial manufacture of bota-vec,” Alexandria Forbes, PhD, president and CEO of MeiraGTx, said in a news release. 

EyePoint Announces Milestones in EYP-1901 Wet AMD and DME Trials

EyePoint announced positive top-line results of its phase 2 DAVIO 2 trial of EYP-1901, an investigational sustained delivery maintenance treatment for wet AMD combining vorolanib, a selective tyrosine kinase inhibitor, with bioerodible Durasert E. The clinical trial met its primary endpoint with both EYP-1901 doses demonstrating statistical noninferiority change in best corrected visual acuity compared to aflibercept control and a favorable safety profile with no ocular or systemic serious adverse events related to EYP-1901. EyePoint also announced that the first patient has been dosed in the phase 2 VERONA clinical trial of EYP-1901 for diabetic macular edema (DME). The DME trial is expected to enroll approximately 25 patients assigned to 1 of 2 intravitreal doses of EYP-1901 or an aflibercept control. 

“Dosing the first patient in the phase 2 VERONA trial represents another significant milestone in advancing our mission to improve the lives of patients with serious retinal diseases,” Jay Duker, MD, CEO, of EyePoint said in a news release. 

Positive Data From Phase 2 Trial of ABBV-RGX-314 for Wet AMD Reported

Regenxbio announced positive interim data from the phase 2 AAVIATE trial of ABBV-RGX-314 for the treatment of wet AMD via suprachoroidal delivery. The new data, which were presented at the 2024 Hawaiian Eye and Retina meeting, demonstrate that ABBV-RGX-314 was well tolerated across 106 patients from 3 dose levels, with no drug-related serious adverse events. 

“One-time, in-office treatment with ABBV-RGX-314 continues to be well tolerated in patients with wet AMD. We are pleased that dose level 3 in this trial has shown the highest reduction in treatment burden with 0 cases of inflammation observed in patients who received prophylactic short-course topical steroids,” Steve Pakola, MD, chief medical officer of Regenexbio, said in a news release.

First Patient Treated in Phase 2 Study of Antiangiogenic for Wet AMD and DME 

Ashvattha Therapeutics announced that the first patient was dosed with D-4517.2, a subcutaneously administered antiangiogenic therapeutic, in a phase 2 chronic dosing study. The study, which will enroll at least 20 subjects, will evaluate the safety and efficacy of chronic D-4517.2 dosing in patients with wet AMD or DME. 

“This study marks a significant step forward in advancing D-4517.2 as an at-home maintenance treatment option for patients with wet AMD and DME. We believe that D-4517.2 will extend the time between anti-VEGF treatments, thereby reducing the anxiety patients typically experience with intravitreal injections and lessening the burden of frequent office visits,” Jeff Cleland, PhD, chief executive officer and chairman of Ashvattha Therapeutics, said in a news release. 

Long-term Vabysmo Data Shows Sustained Effect

Newly released 72-week data from a pair of phase 3 studies show that Vabysmo (faricimab-svoa; Genentech) sustained robust drying of retinal fluid, leading to reduced swelling and improved vision in patients treated for branch or central retinal vein occlusion (BRVO or CRVO). The data, reported at the 2024 Angiogenesis, Exudation, and Degeneration meeting, also indicates that Vabysmo is effective at extended treatment intervals. 

The BALATON (n=553) and COMINO (n=729) phase 3 studies evaluated the average change in best-corrected visual acuity score from baseline. The studies also tracked the amount of swelling in the back of the eye due to retinal fluid, as measured by central subfield thickness (CST). For the first 20 weeks, patients were randomized 1:1 to receive monthly injections of either Vabysmo (6 mg) or aflibercept (2 mg). From weeks 24 to 72, all patients received Vabysmo (6 mg) up to every 4 months, using a treat-and-extend dosing regimen.

Patients in BALATON who received Vabysmo as a first-line treatment for BRVO gained 18.1 letters on the eye chart at 72 weeks and saw a 310.9 µm reduction in retinal swelling, as measured by CST. Patients who switched from aflibercept to Vabysmo gained 18.8 letters and saw a CST reduction of 307 µm at 72 weeks. In COMINO, patients who received Vabysmo as a first-line treatment gained 16.9 eye chart letters and saw a 465.9 µm reduction in retinal swelling at 72 weeks, while patients who switched from aflibercept to Vabysmo gained 17.1 eye chart letters and saw a CST reduction of 462.3 µm.

New Data Presented for GA Treatment Izervay

A post hoc analysis of pooled data from the GATHER1 and GATHER2 studies showed that Izervay (avacincaptad pegol intravitreal solution; Iveric Bio) continued to slow the growth of geographic atrophy (GA) lesions, compared to sham, for up to 18 months, reported study lead investigator Arshad M. Khanani, MD, MA, FASRS, at the Angiogenesis, Exudation, and Degeneration 2024 symposium. The early treatment effect was observed by 6 months and increased over time, nearly doubling every 6 months through month 18. In addition, Dr. Khanani reported that a separate matching adjusted indirect comparative analysis found avacincaptad pegol improved the treatment effect and demonstrated greater vision preservation, compared to pegcetacoplan (Syfovre; Apellis Pharmaceuticals), for patients with GA secondary to AMD through 12 months.