FDA accepts NDA for dry eye treatment

The FDA accepted an NDA from Aldeyra Therapeutics for reproxalap, the company’s topical, first-in-class investigational drug candidate for the treatment of signs and symptoms of dry eye. According to the company’s press release, the NDA is supported by positive safety and efficacy data from five clinical trials that have included more than 2,000 patients. The PDUFA date assigned is November 23. Reproxalap is designed to reduce reactive aldehyde species levels, which the company explained “may contribute to inflammation, diminished tear production, ocular redness, and changes in tear lipid composition.”

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Phase 2 study moves forward for investigational ocular autoimmune therapy

Kiora Pharmaceuticals announced FDA approval of an investigational NDA for its Phase 2 study that will assess KIO-101 for the treatment of ocular manifestations of autoimmune diseases, including rheumatoid arthritis. According to the company’s press release, the study will enroll about 120 patients, and it will be double-masked, randomized, and controlled to assess safety and efficacy in treating the signs and symptoms of ocular surface disease caused by autoimmune disorders. The study is expected to begin in the first half of 2023 in Australia. According to the company’s press release, KIO-101 is a non-steroidal autoimmune disease drug that is designed to inhibit DHODH to reduce T-cell proliferation and other proinflammatory cells.

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Fast-track designation granted for investigational retinitis pigmentosa treatment

The FDA granted Endogena Therapeutics a fast-track designation for development of EA-2353 for treatment of retinitis pigmentosa. According to the company’s press release, this investigational therapy “selectively activates endogenous retinal stem and progenitor cells, which differentiate into photoreceptors and can potentially preserve or restore visual function.” The company described EA-2353 as a “gene-independent treatment,” which is advantageous because retinitis pigmentosa has different genetic origins. The therapy is currently in a Phase 1/2a dose-escalation study. EA-2353 received an orphan drug designation from the FDA in 2021.

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First-in-human feasibility study data from drug-eluting IOL platform

SpyGlass Pharma announced 6-month data from a first-in-human feasibility study that is evaluating its investigational drug delivery platform, which consists of a single-piece, hydrophobic acrylic IOL that carries drug-eluting pads on the haptics. In this study, the platform is delivering bimatoprost to lower IOP in patients (n=23) with glaucoma or ocular hypertension. Patients were randomized to receive one of three doses with the platform at the time of cataract surgery. The 6-month data showed a 45% reduction in mean IOP without the need for additional therapy, according to the company. There were no significant adverse events, and visual outcomes were similar to those with cataract surgery and IOL implantation with conventional IOLs, the company reported.

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Study identifies the ‘best approach’ for anti-VEGF therapy for diabetic retinopathy

Research from the DRCR Retina Network found that early treatment of diabetic retinopathy does not improve visual acuity, though it does slow disease progression. According to a press release from the National Eye Institute, investigators found that the “best approach” to anti-VEGF therapy for patients with diabetes is regular monitoring and treatment as needed. The study enrolled 328 patients (399 eyes) where preventative anti-VEGF injections were given in some (n=200 eyes) at a cadence of 1 month after enrollment, at 2 months, 4 months, then every 4 months for 2 years. Some study participants (n=199) were given sham injections at the same intervals. According to the press release, additional anti-VEGF therapy was given if macular edema or proliferative diabetic retinopathy developed. Thirty-four percent of eyes receiving anti-VEGF therapy showed disease progression compared to 57% in the sham group. The researchers found that those who received preventative treatment were less at risk for developing macular edema or proliferative diabetic retinopathy, but it didn’t impact their vision.

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ASCRS news and events

• ASCRS Annual Meeting: Registration for the ASCRS Annual Meeting, May 5–8, 2023, in San Diego, California, is ongoing. “Make Waves” in education, innovation, and networking specifically focused on anterior segment surgery.
• ASCRS Annual Meeting Preview Program: The ASCRS Annual Meeting Preview Program is available online with more details about Annual Meeting schedules and programming.
• Eyecelerator: Registration is now open for Eyecelerator@ASCRS 2023. The innovation conference from ASCRS and AAO will be held on May 4 in San Diego, California. Join investors, industry leaders, and ophthalmologists at this showcase of companies, technology, and other exciting innovation topics in ophthalmology. Sponsorship opportunities and opportunities to present at the Eyecelerator Marketplace are available now. More detailed program information will be coming soon.
• ASCRS Podcast: The latest episode of Ophthalmology Quicksand Chronicles, featuring guest David Chang, MD, is online now.

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Research highlights

• Use of a capsular tension ring (CTR) to prevent in-the-bag dislocations after cataract surgery was the subject of a single-center, retrospective, cohort study published in the Journal of Cataract & Refractive Surgery. The study included analysis of medical records from 1996–2017. Of the 68,199 cataract surgeries (46,632 patients) conducted during this time, there were 111 (0.16%) in-the-bag dislocations. The authors found that use of a CTR did lower the risk of such a dislocation, especially in eyes with pseudoexfoliation. Eyes with zonular weakness and a CTR at the time of cataract surgery had a “potentially lower risk,” according to the authors.
• A study published in the journal Ophthalmology investigated the effect of repeated intravitreal injections on the ocular surface and meibomian glands. Ninety patients (mean age 77.5 years) were included in the study. The median number of intravitreal injections in treated eyes was 19.5. Mean meibomian gland loss in the upper lid was 19.1% in treated eyes and 25.5% in untreated eyes. Lower lid meibomian gland loss was 17.4% in treated eyes and 24.5% in untreated eyes. Bulbar redness scores were lower and tear meniscus height was higher in treated eyes vs. untreated eyes. There was no difference in treated or untreated eyes when it came to tear break-up time, Schirmer’s scores, corneal staining, fluorescein tear break-up time, gland expressibility, meibum quality, and other metrics. The authors concluded that repeated anti-VEGF injections with use of preop povidone-iodine “reduced meibomian gland loss, increased tear volume, and reduced signs of inflammation.”

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Product news

• EyeArt AI eye screening by EyeNuk, which is FDA approved in the U.S., was given clearance to market its system in the European Union for screening of AMD and glaucomatous optic nerve damage, in addition to diabetic retinopathy.
• IHEEZO (chloroprocaine hydrochloride ophthalmic gel for ocular anesthesia, Harrow) received a permanent, product-specific J-code (J2403) from CMS.
• Nidek launched the Cube α Ophthalmic Surgical System, which incorporates torsional ultrasound oscillation for phacoemulsification. The company also launched the AL-Scan M Optical Biometer and the MV-1 Myopia Viewer software.
• Tracey Technologies released iTrace Prime, upgraded software (7.0) for its iTrace Ray Tracing Aberrometer and Corneal Topographer.

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