FDA approves robotic OCT color fundus camera with OCTA

Topcon announced that it received 510(k) clearance from the FDA for its Maestro2, which the company stated is the “first and only robotic OCT color fundus camera system with OCTA available in the U.S.” According to the company’s press release, the Maestro2 offers different size OCTA scans to provide high-resolution images of the macula for assessing AMD and also wider areas for assessing diabetic retinopathy and vein/artery occlusions.

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Company to begin Phase 3 trial for Stargardt macular degeneration treatment

Nanoscope Therapeutics announced that it had an end-of-Phase 2 meeting with the FDA for MCO-010, which will support the beginning of a Phase 3 registrational trial for the therapy intended to treat severe vision loss due to Stargardt macular degeneration. According to the company’s press release, the study will be randomized 1:1 with one group receiving a single intravitreal dose of MCO-010 and the other group sham injection. Change in BCVA from baseline to week 52 as tested by ETDRS chart is the proposed primary efficacy endpoint. The company also reported that it was aligned with the FDA to allow patients as young as 12 who are legally blind with vision worse than 20/200 to be enrolled in the Phase 3 study.

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24-month results of oral treatment for geographic atrophy

Alkeus Pharmaceuticals announced 24-month results with its oral therapy for geographic atrophy, gildeuretinol. According to the company’s press release, patients who took gildeuretinol had a clinically meaningful reduction in geographic atrophy lesion growth rate and a statistically significant reduction in rate of decline in low luminance visual acuity. According to the company, these findings support further clinical development and are the first time an oral therapy has had an effect on a functional endpoint in geographic atrophy. The study was double masked, randomized, and placebo controlled to evaluate gildeuretinol’s safety, pharmacokinetics, tolerability, and efficacy in 198 enrolled patients with geographic atrophy. Gildeuretinol, according to the company, is a “novel molecule created as a specialized form of deuterated vitamin A designed to reduce the dimerization of vitamin A without disrupting vision.” The molecule is also being studied in ongoing clinical trials for Stargardt disease.

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Positive Phase 2 results for investigational choroidal melanoma treatment

Aura Biosciences announced positive Phase 2 results from its study evaluating bel-sar (AU-001) as a first-line treatment for early stage choroidal melanoma. The open-label, ascending single and repeat dose escalation trial evaluated safety, tolerability, and efficacy of up to 3 cycles of treatment. Twenty-two patients were enrolled and monitored over 12 months, with tumor control, visual acuity, and tumor growth rate assessed. The treatment achieved a tumor control rate of 80% “among Phase 3 eligible patients who received the therapeutic regimen,” according to the press release (n=8/10). Tumors stopped growing among responders in this treatment group. After treatment was stopped, tumor growth rate was 0.011 mm/year among responders compared to 0.351 mm/year at baseline. Among these 10 patients, 90% achieved visual acuity preservation. The company noted that 80% of these patients were at high risk for vision loss due to the tumors’ proximity to their fovea or optic disc. The company is currently enrolling patients in an ongoing Phase 3 trial.

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Partnership news

• AbbVie and Ripple Therapeutics entered a collaboration and option-to-license agreement to develop RTC-620 as a fully biodegradable, sustained-release drug delivery intracameral implant with redosing ability. The implant is designed to deliver IOP-lowering drugs for patients with open angle glaucoma or ocular hypertension. According to the company’s press release, Ripple will lead preclinical development, and AbbVie, with its option-to-license, will lead the clinical and commercialization activities.
• MicroSurgical Technology (MST) announced its exclusive global partnership with Vista Ophthalmics, introducing the Vista 1-Step, a vitrector that can go through the sclera without MVR blades or trocars, and Vista IS, an anterior chamber maintainer.

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ASCRS news and events

• ASCRS Business of Refractive Cataract Surgery Summit: This new course taking place September 27–28 in Irving, Texas—along with its extensive, take-home resource library—will help practices gain the navigational tools needed to increase advanced-technology IOL adoption and lead patients effectively on their refractive surgery journey. Learn more.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2024. Registration is open for the events in Atlanta, Georgia, on October 3, San Diego, California, on November 7, and Charlotte, North Carolina, on November 14.
• ASCRS Foundation: There are two opportunities for young eye surgeons currently accepting applications: the Young Eye Surgeons International Service Grant and the Resident Excellence Award.
• ASCRS 50th Anniversary: ASCRS members from the 50 states are sending in their perspectives on the Society, its impact on their career, and its influence on the specialty as a whole. Stay tuned each week through April 2025 for a new video.

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Research highlights

• The safety and efficacy of Bio-Hyalur LVD (Biotech Healthcare), a new viscosurgical device for use in cataract surgery, was compared to Viscoat (Alcon) in a prospective, randomized clinical trial involving patients who had phacoemulsification with IOL implantation between January 2021 and April 2022. The primary outcome was mean change in IOP 6 hours postop; secondary outcomes were mean IOP at various timepoints, CDVA, endothelial cell density, change in central corneal thickness, and complications, such as intraocular inflammation. The study enrolled 84 eyes of 84 patients who were randomized to have Bio-Hyalur LVD (n=41) used in their surgery or Viscoat (n=43). According to the research published in the Journal of Cataract & Refractive Surgery, the mean change in IOP was significantly higher in the Viscoat group at 6 hours postop, 7 days, 30 days, and 90 days. Mean change in UDVA and CDVA was significantly higher in the Bio-Hyalur LVD group at 30 and 90 days postop. There were no differences between the groups in endothelial cell density, central corneal thickness, or complication rates. The authors concluded that the new Bio-Hyalur was safe and effective for patients having routine cataract surgery.
• A non-inferiority randomized controlled trial published in the British Journal of Ophthalmology assessed the efficacy and safety of a laughter exercise, compared to a control 0.1% sodium hyaluronic acid drop. Patients with symptomatic dry eye disease with an OSDI score from 18–80 and tear film breakup time of 8 seconds or less were randomized 1:1 to receive the laughter exercise (which was provided via an instructional video and consisted of them vocalizing laughter phrases given to them 30 times in a 5-minute session) or the control drop, 4 times a day for 8 weeks. The study included 299 participants, 283 of whom completed the trial. According to the paper, the mean change in OSDI score at 8 weeks was –10.5 points in the laughter group and –8.83 points in the control group. According to the paper, non-inferiority of the laughter exercise compared to the drop was supported based on confidence interval analysis. The laughter exercise was also better at improving non-invasive tear breakup time, with a mean difference of 2.3 seconds. There was no significant difference in other secondary outcomes, and no adverse events noted in either group.

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