Changes to the pipeline have defined our May 2023 ophthalmology coverage, with approvals from the US Food and Drug Administration (FDA) and topline phase 3 data indicating the efficacy of new therapies for a variety of disease states. Artificial intelligence remained a consistent key theme for our coverage, with stories laying out the potential benefits of their use in the detection of retinal diseases. Finally, our coverage crossed over into other fields of medicine, with research surrounding the effects of the COVID-19 pandemic on intravitreal injections and interesting developments from both the cardiology and sleep medicine space.

For more insight into these developments, check out our May 2023 Month in Review for ophthalmology.

Pipeline Developments

Topline Results from Phase 3 DIAMOND Trial Suggest Efficacy of Topical OCS-01 for DME

Topline results from the phase 3 DIAMOND trial show it met its stage 1 objective of validating the optimal dosing regimen of topical OCS-01 with statistical significance in patients with diabetic macular edema (DME). Announced by Oculis, the analysis showed patients treated with OCS-01 experienced a 7.2 letters improvement in BCVA and a 63.6 µm reduction in CST at 6 weeks compared to vehicle. No topical treatment has before demonstrated a positive result for DME.

Per these positive data, the non-invasive treatment could benefit a large number of patients pending approval from the US Food and Drug Administration (FDA). Stage 2 of the DIAMOND trial will encompass 2 global trials and is expected to begin in the second half of 2023.

FDA Accepts Supplemental BLA for Faricimab for Treatment of Retinal Vein Occlusion

On May 9, the FDA accepted the supplemental Biologics License Application (sBLA) for faricimab-svoa (Vabysmo®) for the treatment of macular edema following retinal vein occlusion (RVO). The sBLA was based on results from the phase 3 BALATON and COMINO studies showing treatment with faricimab-svoa led to early and sustained improvements in vision, meeting the primary endpoint of non-inferior visual acuity gains to aflibercept at 24 weeks. Pending FDA approval, RVO would be the third indication for faricimab-svoa in addition to wet age-related macular degeneration (AMD) and DME, previously approved in January 2022.

FDA Approves Perfluorohexyloctane Ophthalmic Solution for Dry Eye Disease

On May 18, the FDA approved perfluorohexyloctane ophthalmic solution (MIEBO™), formerly known as NOV03, for the treatment of the signs and symptoms of dry eye disease (DED). Announced by Bausch + Lomb and Novaliq, the ophthalmic solution is the first-and-only prescription drop approved for DED that directly targets tear evaporation.

Results from the phase 3 GOBI and MOJAVE trials showed patients with DED treated with perfluorohexyloctane ophthalmic solution experienced relief of symptoms as early as day 15 and through day 57 with a statistically significant reduction in Visual Analog Scale eye dryness score. Additionally, at day 15 and day 57, both studies showed a significant reduction in total corneal fluorescein staining score favoring perfluorohexyloctane ophthalmic solution. The ophthalmic solution is expected to become commercially available in the second half of 2023.

FDA Approves Fixed-Dose Ophthalmic Spray for Mydriasis

On May 8, the FDA approved tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5% (Mydcombi) for inducing mydriasis for diagnostic procedures and in conditions for short-term pupil dilation. Granted to Eyenovia, Inc., the approval is for the first fixed-dose combination of tropicamide and phenylephrine in the US and the first product approved to use the company’s proprietary Optejet® drug delivery technology. The drug-device combination product was designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed every year in the US and the estimated 4 million pharmacologic mydriasis applications for cataract surgery.

Future Uses of Artificial Intelligence

Smartphone-Based Telescreening May Benefit Detection of Retinopathy of Prematurity

A new analysis suggests low field-of-view, cost-effective smartphone-based fundus imaging (SBFI) systems may be both effective and safe in telemedicine screening for treatment-requiring retinopathy of prematurity (ROP). Analyzing 2 separate SBFI systems revealed neither was superior to the other, but both human graders and autonomous artificial intelligence-based systems were able to appropriately refer treatment-requiring ROP using SBFI photos. The use of these systems may be particularly beneficial in regions where widefield digital fundus imaging (WDFI)-based ROP telemedicine or in-person ophthalmoscopic screening are not available, according to the investigative team.

AI-Based Fundus Screening System Could Aid in Early Detection of Ocular Diseases

An artificial intelligence-based fundus screening system used in a real-world setting was able to distinguish between normal and abnormal ocular fundus and diagnose 5 prevalent ocular conditions, with particularly favorable efficacy for diabetic retinopathy (DR), RVO, and pathological myopia. The investigative team indicated the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of the 3 fundus abnormalities were greater (>80%) than those for age-related macular degeneration (AMD), referable glaucoma, and other abnormalities.

Biomarker-Based Artificial Intelligence Able to Infer Race From Retinal Images

New findings from a recent diagnostic study suggest artificial intelligence (AI) can infer self-reported race from retinal fundus images that were not previously thought to contain information relevant to race. The data show AI was able to infer the self-reported race of infants from retinal vessel maps, something human graders are unable to do. As a result, biomarker-based approaches to training AI models may not remove the potential risk for racial bias in practice.

Crossover Coverage

Clinical Diagnosis of Obstructive Sleep Apnea Not Associated with AMD Likelihood

A clinical diagnosis of obstructive sleep apnea (OSA) was not associated with a higher likelihood of age-related macular degeneration (AMD), nor with the presence of reticular pseudodrusen (RPD) with AMD, according to new findings. However, while they were not more likely to have AMD, individuals receiving OSA treatment using an assisted breathing device were 3.7 times more likely to have RPD coexistent with AMD compared with those who were not receiving treatment.

COVID-19 Pandemic Linked to Significant Decrease in Number of Intravitreal Injections

The COVID-19 pandemic was associated with a significant decrease in the number of intravitreal injections for retinal disorders, compared to rates in the pre-COVID period, according to epidemiologic patterns reported in Iran. The data showed a 41.4% decrease in the number of operating visits after the COVID-19 pandemic with a parallel decrease in the number of intravitreal injections. Decreases in injections were significantly higher among patients with AMD who were typically older than patients from other subgroups, and this gap may have resulted in greater vision loss.

AMD with Visual Disability May Be Associated with Increased CVD Risk

Nationwide data from South Korea indicated that AMD was not strongly associated with an increased risk of cardiovascular disease (CVD); however, the risk was increased (17%) when patients with AMD had visual disability. The investigative team stressed the need for a prospective study that specifies a chronological order in AMD and visual disability to enhance the understanding between AMD with visual disability and CVD. In the meantime, they noted patients with AMD and visual disability should be targeted for both risk factor management and CVD prevention.