Positive topline results in trial for retinitis pigmentosa treatment

Nanoscope Therapeutics announced topline results for its investigational therapy targeting retinitis pigmentosa. According to the company’s press release, MCO-010, described as a “mutation-agnostic gene therapy,” achieved its primary and key secondary endpoints with statistical significance and no serious adverse events. The primary endpoint was a statistically significant improvement in BCVA at week 52 in the high-dose and low-dose groups compared to control. A statistically significant improvement in BCVA at 76 weeks (a secondary endpoint) was achieved in the high-dose group, compared to sham, but not in the low-dose group. The company also stated that novel multi-luminance shape discrimination and y-mobility testing showed an 89% response rate in the test groups at week 52. MCO-010 was well tolerated with no treatment-related serious or severe adverse events. The company plans on submitting a BLA to the FDA in the second half of this year.

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Phase 2 trial for first-in-human inflammatory dry eye therapy

OKYO Pharma announced results from its Phase 2 trial for OK-101, noting that statistical significance was achieved for multiple signs and symptoms of dry eye. OK-101, according to the company, is a “lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor,” which is involved in inflammatory response. In the Phase 2 trial, there was a statistically significant improvement in ocular pain as early as day 15 and throughout the trial; conjunctival staining improved as early as day 29 with a durable effect; tear film breakup time showed a statistical improvement as early as day 15 with a durable effect throughout the trial; and burning/stinging and blurred vision improved as early as day 15 with a durable benefit. According to the company, there were no drug-related serious adverse events. With these results, the company plans on entering Phase 3 development with FDA recognized endpoints.

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Landmark clinical trial shows non-inferiority of Nanodropper technology

A prospective, randomized, non-inferiority clinical trial evaluated the efficacy of timolol maleate, 0.5%, dispensed with the Nanodropper Adaptor (Nanodropper) at a volume of 12.5 μL compared to conventional 28 μL drops. According to the study published in the journal Ophthalmology, the timolol drops dispensed with Nanodropper by patients with open angle glaucoma or ocular hypertension showed a significant decrease in IOP compared to baseline at all timepoints and were non-inferior to traditional drops at 3 of the 4 timepoints. The authors also reported seeing less of an effect on resting heart rate and blood pressure in the Nanodropper group. According to the company’s press release, this effect on resting heart rate and blood pressure could suggest an enhanced safety profile of using a lower volume that’s as effective at lowering IOP.

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Dosing complete for gene therapy aiming to help patients with Leber congenital amaurosis

Opus Genetics announced that it completed dosing in its first cohort for its Phase 1/2 clinical trial evaluating its subretinal gene therapy OPGx-LCA5. This AAV8 vector therapy is designed to deliver a functional LCA5 gene to patients with mutations in this gene. According to the company’s press release, based on positive safety and efficacy data in the first cohort of adult participants (n=3), the company will advance to the next highest dose for the following cohort in mid-2024. The company stated that it also plans to expand the study to include patients 13 years and older in the future.

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Enrollment begins for secondary IOL technology Phase 1 pivotal trial

OnPoint Vision announced that it is enrolling for its Phase 1 pivotal trial to evaluate AccuraSee Intraocular Pseudophakic Capsular Lens Magnifier. According to the company, this technology, which has an approved IDE, is designed for secondary implantation in the capsular bag with an already implanted 6-mm acrylic posterior chamber IOL. The AccuraSee implant is a neutral optic with a central +10 D 1.8 mm zone that is designed to magnify near images when implanted in the non-dominant eye and is specifically designed for pseudophakic patients with AMD who are at least 6 months post-cataract surgery.

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Strategic alignment news

iOR partners announced its strategic alignment with the Joint Commission on national accreditation standards for office-based surgery centers. According to the company’s press release, “office-based surgery centers that achieve Joint Commission accreditation drive processes to help reduce risk and raise the bar for outpatient surgical care.”

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ASCRS news and events

• ASCRS Annual Meeting: The ASCRS Annual Meeting will take place next week, April 5–8 in Boston, Massachusetts. There is still time to register online or onsite. Take a look at the 2024 Annual Meeting & Subspecialty Day Real-Time Program for more details.
• EyeWorld Corporate Events: EyeWorld is hosting more than a dozen Corporate Education events during the ASCRS Annual Meeting in Boston. Click here to learn more about these opportunities and to pre-register.

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Research highlights

• Posterior capsule rupture (PCR) rates during cataract surgery with a traditional ophthalmic surgical microscope or a 3D heads-up visualization system were reviewed in this retrospective study that took place at a single tertiary referral center. The study included 10,101 surgeries over a 4-year period; 1,964 were performed using 3D displays by two surgeons, and 8,137 were performed using traditional operating microscopes by 6 surgeons. According to the study published in the Journal of Cataract & Refractive Surgery, PCR rates were not significantly different between the two groups, 0.7% in the traditional scope group and 0.9% in the 3D display group. The mean surgical time was significantly longer in the 3D display group (10.6 minutes) compared to the traditional scope group (9.9 minutes). The authors noted that while not significant, the PCR rate in the 3D display group decreased over time.
• A single-center, double-masked randomized controlled trial published in the journal Ophthalmology evaluated a dexamethasone intracanalicular insert for treatment of dry eye. The study included 75 patients with clinically significant aqueous-deficient dry eye who still showed signs and symptoms despite treatment with a prescription drop. Patients were randomized 1:1 to receive either the dexamethasone insert or a collagen plug (sham); the patient’s other eye received the opposite treatment. According to the paper, dry eye severity at baseline was comparable between the treatment arms. Eyes that received the dexamethasone insert showed significantly less corneal and conjunctival staining at week 4. Schirmer’s scores were comparable between the two groups. The authors noted that patients reported feeling less dryness in the eye that received the dexamethasone insert at 4 weeks, but there was no statistically significant difference in patient-reported symptoms. The authors reported that eyes with the dexamethasone insert were more likely to experience an IOP increase at week 4, but in all cases IOP was managed and resolved with short-term topical beta blockers.

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Product news

• Iveric Bio, an Astellas Company, received a permanent J-code (J2782) from CMS for treatment of geographic atrophy secondary to AMD. This J-code is effective on April 1.

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