Rare Pediatric Disease designations granted for gene therapies

Two companies announced this week that they received Rare Pediatric Disease designations from the FDA for the gene therapies they are developing. Opus Genetics earned a Rare Pediatric Disease designation for OPGx-LCA5. This therapy, according to the company’s press release, is designed to treat patients with inherited Leber congenital amaurosis at the LCA5 gene, delivering a functional copy of the gene. The second Rare Pediatric Disease designation for an ocular gene therapy was granted to Atsena Therapeutics for ATSN-201 for treatment of X-linked retinoschisis.

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Tentative FDA approval granted to generic drop for eye redness

Lupin announced that it received tentative approval from the FDA for its Abbreviated New Drug Application for brimonidine tartrate ophthalmic solution, 0.025%. This is, according to the company’s press release, a generic equivalent to Lumify (Bausch + Lomb). The drop is indicated to reduce eye redness.

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Acquisition news

Visiox Pharmaceuticals announced a merger agreement with Ocuvex Therapeutics. According to the company’s press release, Ocuvex has a pipeline of “near-term ophthalmic medicines,” focused on therapies for glaucoma and other disorders. The company will operate under the Ocuvex name.

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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 nine cities across the U.S. Registration is open for events in Cleveland, Ohio, September 12 and Atlanta, Georgia, October 3.
• ASCRS Annual Meeting: The call for abstract submissions for the 2025 ASCRS Annual Meeting has been extended through September 3. Submit your abstracts now.
• ASCRS Foundation: Residents, fellows, and surgeons within their first 5 years of practice with an interest in global eyecare are encouraged to apply for the Young Eye Surgeons International Service Grant. Learn more 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

• A randomized clinical trial of 186 participants sought to evaluate whether capsular tension rings (CTR) reduced intraocular lens tilt and decentration in highly myopic eyes (those with an axial length of 26 mm or more). Patients were placed into three groups based on their axial length and randomly assigned to receive a C-loop IOL with a CTR or a C-loop IOL alone. The group that received a CTR showed smaller IOL decentration and tilt at 3 months postop. Lower proportions of clinically significant decentration and tilt was also observed in the CTR group compared to control at 3 months postop. There was a smaller change in IOL decentration at 1 week postop and at 3 months postop, with higher prediction accuracy, better visual quality, and better patient satisfaction in the group of eyes with a CTR that also had an axial length of 30 mm or more. The authors reported that “similar results were only found in eyes with an [axial length] of 30 mm or longer,” and they concluded that “these findings support the use of CTR implantation in eyes with an [axial length] of 30 mm or longer and implanted with C-loop IOLs.” The research is published in JAMA Ophthalmology.
• Postoperative endophthalmitis—incidence, predictive factors, etiology, and visual consequences—related to three intracameral antibiotics was evaluated in an observational retrospective study based on data from the Swedish National Cataract Registry from 2011 through 2017. The authors of the research published in the Journal of Cataract & Refractive Surgery found that the overall incidence of postop endophthalmitis during this timeframe was 0.023% (177 cases out of 764,513 cataract procedures). The rates were 0.024%, 0.020%, and 0.017% for intracameral cefuroxime, moxifloxacin, and combined cefuroxime-ampicillin, respectively. The incidence of postop endophthalmitis was not statistically significant different between the groups. The cause in 89.0% of cases were Gram-positive bacteria with enterococci occurring more frequently in the patients who had intracameral cefuroxime than moxifloxacin or cefuroxime-ampicillin. Streptococci was more common with moxifloxacin than with cefuroxime, according to the authors. Visual outcome of worse than 20/200 was similar among the different intracameral antibiotic groups.

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Product news

• Glenmark Therapeutics announced the launch of olopatadine hydrochloride ophthalmic solution USP, 0.1%, which its press release compared to the active ingredient of Pataday Twice Daily Relief (Alcon), indicated for itchy eyes due to allergies.

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