Ophthalmology Month in Review: August 2024

In our ophthalmology month in review for August 2024, the US Food and Drug Administration (FDA) approved an expanded access program for OCU400 gene therapy for retinitis pigmentosa. Two-year data from the MERLIN trial showed brolucizumab 6 mg remained non-inferior to aflibercept 2 mg for neovascular age-related macular degeneration (nAMD) but continued to demonstrate worrying safety signals.

A switch to faricimab in patients with insufficient response to other anti-VEGF therapy for diabetic macular edema (DME) improved short-term anatomical outcomes, while initial treatment with panretinal photocoagulation (PRP) followed by anti-VEGF therapy was linked to an increased need for pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDR).

The latest HCPLive feature tackled the potential role of metformin in the GA treatment armamentarium, and the next steps necessary to meet an unmet need, despite the recent FDA approvals of two new agents. An AI detection model demonstrated its capability for early and accurate detection of pediatric eye diseases using smartphone images

Finally, nationwide data showed postoperative endophthalmitis rates have decreased in the past two decades in the US, with similar declines in vitrectomy as a first-line treatment for the complication.

Pipeline News

FDA Approves OCU400 Expanded Access Program for Retinitis Pigmentosa

The FDA has approved an expanded access program for the treatment of adults with retinitis pigmentosa with OCU400, a modifier gene therapy product candidate.

Announced by Ocugen on August 5, 2024, the EAP is open for patients with early, intermediate to advanced RP, with at least minimal retinal preservation, who may benefit from the drug’s mechanism of action before Biologics License Application (BLA) approval.

MERLIN: Brolucizumab Linked to Higher Intraocular Inflammation Rates At 2 Years

Two-year results from the Phase 3a MERLIN trial showed brolucizumab 6 mg was non-inferior to aflibercept 2 mg in BCVA change from baseline in eyes with nAMD, remaining consistent with the 1-year data.

However, despite leading to robust improvements in anatomic outcomes, brolucizumab also demonstrated an increase in intraocular inflammation (IOI), including retinal vasculitis and retinal vascular occlusion, over the 104-week study period.

Switch to Faricimab Improves Short-Term Anatomical Outcomes in DME

A switch to faricimab led to a notable reduction in central retinal thickness (CRT) and volume (CRV), in patients with DME, while BCVA showed a lack of significant functional improvement. This retrospective chart review evaluated real-world data in patients with DME treated with intravitreal faricimab, who demonstrated an insufficient response to prior anti-VEGF therapy.

Tried and True: Exploring Metformin’s Potential for Geographic Atrophy

A new era in retinal care was born with first-time FDA approvals for GA treatments in 2023. Designed to halt the progression of GA, both drugs fell short of preventing the disease or improving visual acuity. The search remains for the next addition to the GA treatment landscape.

In the latest HCPLive feature, experts explored the potential role of metformin in the GA treatment armamentarium, and the next steps necessary to meet an unmet need.

Updates in Ophthalmology

Postoperative Endophthalmitis Rates Notably Declined Over 20 Years

Postoperative endophthalmitis rates have decreased in the past two decades in the US, with similar declines in vitrectomy as a first-line treatment for the complication.

Between 2000 and 2022, endophthalmitis rates decreased by 75%, with an adjusted average decrease of 2.7% per year. In the same period, the rate of vitrectomy for endophthalmitis decreased by 3.8% per year.

AI Model Detects Pediatric Eye Diseases Using Smartphone Images

An AI detection model showed a strong performance for early and accurate detection of pediatric eye diseases using smartphone images, including myopia, strabismus, and ptosis.

After examining more than 1400 facial photographs from nearly 500 individuals, the deep learning-based AI model achieved high accuracy in detecting all 3 pediatric eye diseases, with a comparable performance in both male and female children.

Treatment Order with Panretinal Photocoagulation Influences PDR Outcomes

Initial treatment with panretinal photocoagulation (PRP), followed by anti-VEGF therapy, was linked to an increased need for pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDR) compared with anti-VEGF therapy first.

Collecting data from January 2003 to January 2024, the retrospective analysis found the PRP-first treatment cohort also experienced a greater risk of vitreous hemorrhage and tractional retinal detachment.