First patient enrolled in Phase 3 trial evaluating phentolamine ophthalmic solution

Ocuphire Pharma announced that it has enrolled its first patient in a Phase 3 registration study that will evaluate phentolamine ophthalmic solution 0.75% for treatment of decreased visual acuity in mesopic conditions after keratorefractive surgery. According to the company’s press release, there are no FDA-approved treatments for the low contrast visual acuity and other aberrations that can occur in these low-light conditions. The company reported that phentolamine in a prior Phase 3 study met its primary endpoint with 13% of patients gaining 15 or more ETDRS letters in mesopic distance visual acuity at day 8 compared to 3% on placebo.

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FDA clears IND amendment for Phase 3 retinitis pigmentosa gene therapy study

Ocugen announced that the FDA gave clearance for its IND amendment to begin a Phase 3 clinical trial for OCU400, a modifier gene therapy being developed for retinitis pigmentosa. According to the company, OCU400 is the first therapy to enter phase 3 trials with a broad indication of retinitis pigmentosa. The study will enroll 150 participants—75 with the RHO gene mutation and 75 who are gene agnostic. Within these arms, patients will be randomized 2 to 1 to be in the treatment or control group, respectively. The study will use a sensitive mobility course (the Luminance Dependent Navigation Assessment), which the company stated will allow enrollment of patients with early through advanced disease stages.

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Successful pre-submission meetings held for bioengineered corneal implants

Pantheon Vision announced that it has held two productive pre-submission meetings with the FDA for its development of bioengineered corneal implants. According to the company’s press release, these meetings provide guidance on the preclinical and clinical work that the company hopes will support its Premarket Approval submission.

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Study: AI chatbots pass ophthalmology board certification questions

According to a study published in the journal Eye, Google’s Gemini and Bard artificial intelligence chatbots were evaluated in answering ophthalmology board certification questions. The chatbots’ accuracy, response length, response time, and provision of explanations to questions on the EyeQuiz platform, which contains board practice questions, were evaluated. According to the paper, Gemini and Bard from the U.S. were 71% accurate in 150 text-based multiple-choice questions. In secondary analysis, Bard from Vietnam was 67% accurate with 21% of questions answered differently than Bard from the U.S., and Gemini Vietnam was 74% accurate at answering questions with 15% answered differently than the U.S. version. The Brazil and Netherlands versions of Gemini performed at 68% and 65%, respectively. The authors noted, however, that the differences in performance across these country-specific versions of the Google AI chatbots was not statistically significant. The authors also wrote that the chatbots provided confident explanations, even when their answers were wrong. According to the paper, “understanding the potential of artificial intelligence (AI) chatbots in a medical context is important.”

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ASCRS news and events

• ASCRS Annual Meeting: Hotel blocks are open for the 2025 ASCRS Annual Meeting in Los Angeles, California, April 25–28, 2025. If you were not at the 2024 ASCRS Annual Meeting, review onsite coverage in EyeWorld Daily News.
• ASCRS Live!: This new dinner series, making its way to nine cities, is continuing to bring ASCRS education around the U.S. See where it’s heading next.
• ASCRS 50th Anniversary: Review historical videos, watch member accounts, and scroll through the timeline—all brought together on these webpages to celebrate the Society’s historic anniversary.

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Research highlights

• A laboratory investigation published in the Journal of Cataract & Refractive Surgery sought to objectively quantify glare associated with diffractive presbyopia-correcting IOLs and identify those that are more likely to induce glare. According to the paper, glare was assessed with a “straylight parameter with a standard C-Quant intended for 7 degrees.” The authors also used “2 C-Quant modifications to test lower angles.” PanOptix (Alcon), AT Lisa Tri (Carl Zeiss Meditec), Synergy (Johnson & Johnson Vision), and Triumf (FineVision) were included in the analysis and compared to the W-60R monofocal IOL. Overall, the authors found that “trifocal IOLs induced increased straylight, but it was limited to lower angles.” They wrote that this could “cause difficulties detecting these effects using a standard clinical approach.” They also concluded that IOL designs with “chromatic aberration correction at far focus seem more susceptible than the established trifocal IOLs to inducing a glare phenomenon.”
• The refractive and visual outcomes of femtosecond laser-assisted astigmatic keratectomy (FSAK) and toric IOLs for astigmatic correction at the time of cataract surgery were compared in a systematic review and meta-analysis with trial sequential analysis published in the British Journal of Ophthalmology. The analysis included 9 studies that had a total of 590 participants. The authors found that toric IOLs resulted in less postop refractive cylinder and provided better UDVA compared to FSAKs. The trial sequential analysis, according to the authors, found “strong evidence of lower postoperative refractive cylinder in the toric IOL group compared with that of the FSAK group.” The AK group had a smaller correction index and lower target-induced astigmatism and surgically induced astigmatism compared to toric IOLs. The authors concluded that toric IOLs are the preferred choice for astigmatic correction but noted that femtosecond AKs are a viable alternative when torics are contraindicated.

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