Fast Track Designation granted for investigational retinitis pigmentosa therapy

Nacuity Pharmaceuticals announced that it received a Fast Track Designation from the FDA for NPI-001 tablets as an investigational therapy for treatment of retinitis pigmentosa. NPI-001, according to the company’s press release, is a “GMP-grade formulation of N-acetylcysteine amide (NACA) tablets being developed to target oxidative stress associated with diseases such as retinitis pigmentosa.” The company stated that preclinical studies have shown the ability of NPI-001 to boost glutathione, an endogenous antioxidant, stopping oxygen molecules from damaging retina cells. NPI-001 also has an Orphan Drug Designation.

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Three-month data for first-in-class dual inflammasome inhibitor for geographic atrophy

Inflammasome Therapeutics announced topline, 3-month data from its clinical trial investigating a first-in-class dual inflammasome inhibitor (K8) for treatment of geographic atrophy (GA). According to the company’s press release, the U.S. clinical trial included 5 patients with bilateral GA who received sustained-release intravitreal implants of K8, which were found to be well tolerated with no drug-related ocular or systemic serious adverse events. The company also reported that all of the eyes treated with the K8 implant “displayed rapid and substantial reduction of GA lesion growth” compared to the contralateral eye that was not treated. More specifically, mean lesion growth in treated eyes was 66% less than untreated eyes at 8 months with a single implant. The company is now conducting an expanded 30-patient trial.

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Clinical updates for sustained-release drug implant treating glaucoma

Glaukos announced several clinical updates for its iDose TR (travoprost intracameral implant), 75 mcg. Updates included that new 36-month follow-up analysis of two Phase 3 pivotal clinical trials showed “sustained substantial IOP reductions as approximately 70% of iDose TR subjects remained well-controlled on the same or fewer IOP-lowering topical medications at 36 months after a single administration of iDose TR, versus 58% of timolol control subjects.” Glaukos also announced that it began a Phase 2b/3 clinical program for iDose TREX, the next generation sustained-release procedural platform therapy, designed to be similar in size as the original iDose but with twice the drug capacity. Finally, the company announced new 6-month follow-up of a Phase 4 single arm study that evaluated 60 patients with open angle glaucoma who received iDose TR in combination with cataract surgery; this study found a mean IOP reduction of 11.3 mm Hg (a 44% reduction compared to baseline) at 6 months postop.

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Gene therapy program receives Rare Pediatric Disease Designation

The FDA has granted a Rare Pediatric Disease Designation to MeiraGTx Holdings’ AAV8-RK-RetGC for treatment of Leber congenital amaurosis due to GUCY2D mutations. According to the company’s press release, this is the fourth Rare Pediatric Disease Designation the company has received in the last 3 months, with other therapies being approved for LCA4 retinal dystrophy, Bardet-Biedl syndrome due to BBS10 mutations, and RDH12-associated retinal dystrophy.

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Study: lasting effect of multifocal contact lenses for myopia progression

The Bifocal Lenses in Nearsighted Kids 2 (BLINK2) study, which involved follow-up with participants of the original BLINK study where patients wore multifocal soft contact lenses for 2 years and single-vision contact lenses for a third year, sought to determine whether rebound occurred after treatment stopped. Ultimately, there was no evidence of loss of treatment effect after discontinuing multifocal contact lens use in the BLINK2 study. The investigators found that eye growth and myopia progression returned to “faster but age-expected rates,” but the prior treatment effect was not diminished. In contrast, a news story from the University of Houston on the study reported that other myopia treatments (atropine drops and orthokeratology) have showed a rebound effect after discontinuing treatment. The investigators concluded that the “data suggest eye growth and myopia progression returned to faster but age-expected rates and support continuing multifocal lenses until cessation of elongation and progression.” The research is published in JAMA Ophthalmology.

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ASCRS news and events

• 2025 ASCRS Annual Meeting: Registration is open for the ASCRS Annual Meeting, taking place April 25–28, in Los Angeles, California. Find the Preview Program here.
• Online education: There are a few recently posted online education opportunities from ASCRS: 1) ASCRS Ground Rounds, 2) a webinar focusing on OCT from the Retina Clinical Committee, 3) ASCRS Live! Roundtable, and 4) a YES Connect webinar.
• The Winning Pitch Challenge: The Winning Pitch Challenge ahead of the ASCRS Annual Meeting will be back on April 24 in Los Angeles, California. Submissions for innovative ideas that could impact the future of eyecare are being accepted now through February 14. Cash prizes for winners are worth up to $25,000. Find more information on submissions here.
• 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 initial surgical experience and learning curve with miCOR 700 (Carl Zeiss Meditec), a new finger-controlled lens extractor that does not use ultrasound, was reported in a single-center, single-surgeon, non-comparative, retrospective, consecutive case series. The study, published in the Journal of Cataract & Refractive Surgery, included 61 eyes of 51 individuals. According to the paper, “increased surgical experience significantly reduced procedural time, nuclear removal time, and cortex removal time with the device.” Higher nuclear densities resulted in longer procedure and nuclear removal times. In the case series there was one posterior capsular rent, though it was unrelated to the lens extractor. There were no cases of thermal damage at the corneal wound site. Postop CDVA improved significantly in all eyes, and all cases of corneal edema and IOP spike resolved within the month, according to the paper. The authors concluded that the “miCOR 700 lens extractor offers an innovative, cost-effective approach to cataract surgery. Further research is needed to compare it with conventional phacoemulsification techniques.”
• The rate of cataract surgery complications in patients with and without prior intravitreal injections was compared in a retrospective cohort study based on TriNetX, an aggregated electronic health records research network. The study, published in the American Journal of Ophthalmology, included patients who had intravitreal injection therapy within 20 years prior to cataract surgery (n=14,240) compared to the same number who had not had intravitreal injections. The authors found “a high rate … of aggregate complications within 90 days of cataract surgery” in the group that had prior intravitreal injections compared to controls. This group had an increased risk for retinal detachment repair at 30 and 90 days postop. The authors reported no other complications associated with prior intravitreal injection.

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Product news

• Rayner announced the commercial launch of its RayOne Galaxy IOL and also approval of the RayOne EMV in Canada.

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