First gene therapy treatment for macular telangiectasia type 2 performed outside of trial

Neurotech Pharmaceuticals announced that it performed its first encapsulated cell-based gene therapy, ENCELTO (revakinagene taroretcel-lwey), for a patient with idiopathic macular telangiectasia type 2 (MacTel). This is the first and only FDA approved treatment for this condition, slowing the loss of photoreceptors and maintaining visual function, according to the press release.

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First patient enrolled in Phase 2b study of ocular micro implant for IOP reduction

PolyActiva has enrolled the first patient in the U.S. for its Phase 2b trial evaluating PA5108, which it described as an “investigational, new chemical entity (NCE), intracameral ocular micro implant, for the reduction in intraocular pressure (IOP) for patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT).” The implant carries latanoprost acid, intended to lower IOP in a completely biodegradable implant over 6 months. A Phase 2a study conducted in Australia showed consistent, statistically significant IOP reductions from a single implant and demonstrated the feasibility of repeat dosing after 6 months. The Phase 2b study will enroll about 75 patients at 12 U.S. sites, with participants receiving either an 80 mcg or 160 mcg dose in one eye and topical latanoprost in their other eye. A control group will receive the topical treatment in both eyes. A second implant will be received at week 26. Patients will be monitored for up to 58 weeks.

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Fast Track Designation granted to Stargardt gene therapy

AAVantgarde Bio announced that it received a Fast Track Designation from the FDA for AAVB-039, a gene therapy program for treatment of Stargardt disease secondary to biallelic mutation in the ABCA4 protein. According to the company, this therapy has the potential to address the genetic cause of the disease, providing a full-length ABCA4 protein, benefitting all patients with these mutations. The therapy is in a Phase 1/2 clinical trial.

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FDA Special Protocol Assessment for non-proliferative diabetic retinopathy trial

Ocular Therapeutix announced that the FDA issued a Special Protocol Assessment (SPA) for the company’s registrational trial for AXPAXLI (OTX-TKI) for treatment of non-proliferative diabetic retinopathy. The company’s president and CEO said this trial could “broaden the impact of AXPAXLI beyond wet AMD into diabetic eye disease.” The SPA provides the company with a clear regulatory path. A Phase 1 trial with one injection of AXPAXLI in patients with non-proliferative diabetic retinopathy found no progression or vision-threatening complications at 48 weeks in the treatment group, compared to 25% progression and 40% vision-threating complications in the sham control group. The company plans to discuss more details regarding this registrational trial during its investor day on September 30.

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IDE granted to new glaucoma therapy system

Myra Vision (Shifamed) announced conditional approval by the FDA for its Investigational Device Exemption to begin a prospective, non-randomized, open-label trial to evaluate the Calibreye Titratable Glaucoma Therapy Surgical System for treatment of refractory glaucoma. According to the company’s press release, the study will enroll up to 70 patients with refractory glaucoma. The Calibreye System is an aqueous shunt that enables outflow adjustments at the slit lamp for personalized therapy that increases or decreases outflow, according to the company.

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Partnership news

• Lupin announced its partnership with Sandoz Group to market and commercialize Lupin’s biosimilar ranibizumab in the E.U. (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia.

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ASCRS news and events

• Business of Refractive Cataract Surgery (BRiCS) Summit: This course, taking place October 3–5, in Chicago, Illinois, along with its extensive, take-home Resource Library, will help practices gain the navigational tools needed to increase premium IOL adoption and lead patients effectively on their refractive surgery journey. Learn more.
• Business of Interventional Glaucoma: This program seeks to provide ophthalmology professionals with the tools and strategies needed to effectively manage and grow interventional glaucoma services. The next program will take place on Thursday, October 16 from 9:00 a.m.–4:00 p.m. at the Rosen Centre in Orlando, Florida. Learn more.
• ASCRS Live!: This educational dinner series is heading to several cities across the U.S. in 2025. Registration is open for the next event in Salt Lake City, Utah, on August 21.
• 2026 ASCRS Annual Meeting: Hotel room blocks are open for the 2026 ASCRS Annual Meeting, taking place in Washington, D.C., April 10–13, 2026. The call for submissions is also ongoing until September 1. Submit an abstract and get involved in the 2026 ASCRS Annual Meeting.

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Research highlights

• A retrospective medical review between March 2023 and March 2024 sought to better understand the association between the development of cystoid macular edema in phakic eyes, especially those with a history of glaucoma surgery, treated with omidenepag isopropyl (OMDI). The study included 836 patients treated with OMDI, 86 of whom had a history of trabeculectomy. In the study, 8 eyes from 6 patients with prior trabeculectomy developed CME. This occurred between 6–11 months after OMDI treatment. After CME onset, visual acuity declined 0–3 lines. Three eyes received a topical NSAID, 2 eyes systemic corticosteroids, and 3 eyes recovered just by discontinuing the OMDI treatment without additional therapy. After CME resolved, visual acuity ranged from 20/20 to count fingers within 28–91 days. No reoccurrence of CME was observed in the 5.5–12 month follow-up period after CME resolution. The authors concluded that CME could develop with OMDI use in patients with phakic eyes and history of trabeculectomy. They cited the need for further studies to better understand the “magnitude of this association and risk factors for this finding.” The study is published in JAMA Ophthalmology.
• Efficacy of IV sedation vs. non-IV sedation for routine cataract surgery was reviewed in a paper published in the Journal of Cataract & Refractive Surgery. The literature review and meta-analysis yielded 12 randomized clinical trials that comprised 1,130 patients. The authors found that IV sedation was “associated with significantly decreased pain compared to no sedation.” There was no difference in patient-reported pain when comparing IV vs. oral sedation. There were also no significant differences in complications between IV and oral sedation.

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Product news

• The Enova Hydrophobic Intraocular Lens, delivered with the Rotaryjet Preloaded Delivery System, was launched by VSY Biotechnology.

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