FDA approves expanded access for retinitis pigmentosa gene therapy

Ocugen announced that it received FDA approval to begin an expanded access program for OCU400 for adult patients with retinitis pigmentosa. The modifier gene therapy product has completed a Phase1/2 study with positive results and is currently being used in a Phase 3 clinical trial. According to the company’s press release, the expanded access program allows patients with serious or life-threatening medical conditions to access treatment outside of the clinical trial when the product is not yet FDA approved. OCU400, in this program, is available for patients with early, intermediate, and advanced retinitis pigmentosa with minimal retinal preservation. OCU400 is based on the gene NR2E3, which regulates various functions in the retina, including photoreceptor development and maintenance, metabolism, phototransduction, inflammation, and cell survival, according to the company.

Back to top

Generic steroid receives FDA approval for inflammation

Lupin announced FDA approval of its Abbreviated New Drug Application for prednisolone acetate ophthalmic suspension, 1%, which the company’s press release stated is the generic equivalent of Pred Forte (AbbVie). The FDA also granted Lupin a Competitive Generic Therapy Designation for 180 days. The drug is indicated for steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment.

Back to top

AI-powered smart glasses provide visual help to patients with AMD

Eyedaptic introduced its next-generation smart glasses, EYE6 with Ivy, a virtual assistant, designed to use artificial intelligence (AI) to help patients with AMD and retinal disorders. According to the company’s press release, EYE6 with Ivy helps the wearer “visualize and interpret real-time information,” including reading text, locating objects, and describing a room.

Back to top

ASCRS news and events

• ASCRS Business of Refractive Cataract Surgery Summit: This new course will help practices gain the navigational tools needed to increase advanced-technology IOL adoption and lead patients 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 Minneapolis, Minnesota, August 15 and Cleveland, Ohio, September 12.
• ASCRS Annual Meeting: The call for abstract submissions for the 2025 ASCRS Annual Meeting closes August 26. 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.

Back to top

Research highlights

• A cohort study sought to determine if there has been any change in the rate of endophthalmitis after intraocular procedures or the primary treatments for endophthalmitis cases within this timeframe. The study published in JAMA Ophthalmology included intravitreal injections, cataract surgery, glaucoma surgery, procedures for retinal conditions, and corneal transplants that took place from 2000 to 2022; procedural data with at least 6 months preop and 6 weeks postop was eligible for inclusion in the study. Patients with previous diagnoses of endophthalmitis or another intraocular procedure after the initial one were excluded for a total of more than 5.8 million intraocular procedures and 4,305 cases of endophthalmitis found, for a rate of 0.07% over the 22-year period. The authors noted the rate of endophthalmitis over the years varied but generally declined. Cases treated with prompt vitrectomy also varied but declined over time. The per-year decrease of endophthalmitis was 2.7% in the 22-year period. The authors concluded that there was a substantial decrease in endophthalmitis rates following intraocular procedures in the last 2 decades, and prompt vitrectomy was less frequently the treatment of choice for these cases.
• The effect of scleral tunnel length on the effective lens position and tilt of an IOL placed via flanged intrascleral haptic fixation (ISHF) was evaluated in a retrospective case-control study published in the Journal of Cataract & Refractive Surgery. The study included 55 eyes that had ISHF with 1.0 mm scleral tunnels and 42 with 2.0 mm scleral tunnels. Mean postop anterior chamber depth, vertical tilt angle, and spherical equivalent in the 1.0 mm group were 5.27±0.39 mm, 6.04±4.87 degrees, and 0.38±1.03 D, respectively. The authors reported that anterior chamber depth and vertical tilt angle in the 1.0 mm group were larger than that of the other group, and postop spherical equivalent was more hyperopic. The 2.0 mm group had a lower frequency of tilt greater than 7 degrees. Overall, the authors concluded that “a shorter tunnel yielded a more unstable IOL position, greater variation in angle and tunnel length, and longer ACD during ISHF.” They wrote, “an exact 2.0 mm tunnel must be created on both sides to achieve a stable and predictable IOL position.”
• Apotex and Formosa Pharmaceuticals entered into a licensing agreement for exclusive rights in Canada to commercialize clobetasol propionate ophthalmic suspension, 0.05%, which is FDA approved for inflammation and pain following ocular surgery.
• LumiThera announced a Category III CPT code, which will go into effect January 1, 2025, for photobiomodulation therapy of the retina.

Back to top

Product news

• Apotex and Formosa Pharmaceuticals entered into a licensing agreement for exclusive rights in Canada to commercialize clobetasol propionate ophthalmic suspension, 0.05%, which is FDA approved for inflammation and pain following ocular surgery.
• LumiThera announced a Category III CPT code, which will go into effect January 1, 2025, for photobiomodulation therapy of the retina.

Back to top

---