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Ophthalmology Management

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Quick Notes: December 6, 2023

Positive data reported for wet AMD treatment; study suggest signs of glaucoma may be detectable years in advance; and more.

Ophthalmology Management December 6, 2023

  • EyePoint Pharmaceuticals announced positive topline results of its Phase 2 DAVIO 2 trial of EYP-1901, an investigational sustained delivery maintenance treatment for wet AMD combining vorolanib, a selective tyrosine kinase inhibitor with bioerodible Durasert E. The clinical trial met its primary endpoint, with both EYP-1901 doses demonstrating statistical non-inferiority change in BCVA compared to aflibercept control and a favorable safety profile with no EYP-1901-related ocular or systemic serious adverse events. The trial also achieved key secondary endpoints with both EYP-1901 doses, including an over 80% reduction in treatment burden, nearly two-thirds of eyes supplement-free up to 6 months and over 80% receiving only zero or one supplement up to 6-months. Additionally, there was strong anatomical control with both EYP-1901 cohorts as measured by optical coherence tomography. For more, see the study results here.

  • According to J&J Vision’s recent Women in Ophthalmology survey, more than one-third (36%) of female ophthalmologists believe that there is a glass ceiling preventing them from reaching their career aspirations as an ophthalmologist. The survey included questions related to the survey respondents’ medical school experience, patient harassment, mentorship and more. OM caught up with Lori Tierney, president, Americas, J&J Vision, along with two ophthalmologists who shared their thoughts on the survey results. Read the web exclusive article here.

  • Research funded by the National Eye Institute suggests that low density of pigment in the macula is associated with thinning of the retina and may serve as an early warning sign of glaucoma. The findings are based on nearly 400 women who were followed for 15 years. Published in the British Medical Journal Open Ophthalmology in October, the study assessed the relationship between macular pigment optical density and retinal thickness, which were measured at baseline among 379 women. Fifteen years later, 32 of these women (50 eyes) had developed glaucoma. Compared with those women who did not have glaucoma, those who did were older and more likely to have had low macular pigment density at baseline. They also had thinner retinal layers in the macula that correspond to those areas affected in glaucoma. According to the study’s lead investigator, the results provide important clues concerning the underlying biological relationship between macular pigment density and glaucoma. The findings also suggest that supplementing diets with sources of lutein and zeaxanthin may prevent glaucoma or its progression.

  • Since announcing its new vision health features to help reduce the risk of myopia, Apple’s new Screen Distance feature is now available for Apple iPhone users. The Screen Distance feature in Screen Time uses the TrueDepth camera (on supported models) — the same TrueDepth camera that powers Face ID — to detect when the iPhone is held closer than 12 inches for an extended period, and encourages the user to move it farther away. According to the iPhone user guide, Screen Distance can remind younger users to engage in healthy viewing habits that can lower their risk of myopia. It gives adult users the opportunity to reduce digital eyestrain. Screen Distance is turned on by default for children under 13 in a Family Sharing group.

  • Harrow announced the completion of the transfer to Harrow of the new drug application for TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL, a synthetic corticosteroid indicated for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids as well as visualization during vitrectomy. In January, Harrow agreed to acquire the US commercial rights to TRIESENCE. Aside from the transfer of the TRIESENCE NDA ahead of the date previously agreed to, all other acquisition terms remain unchanged.

  • Atsena Therapeutics announced positive 12-month safety and efficacy data from the ongoing Phase 1/2 trial of ATSN-101, the company’s investigational gene therapy for the treatment of GUCY2D-associated Leber congenital amaurosis (LCA1). At 12 months post-treatment, ATSN-101 conferred clinically meaningful improvements in vision at the highest dose with no serious treatment-emergent adverse events. Ocular inflammation was mild and reversible with steroid treatment. For high-dose patients, the mean change from baseline in dark-adapted full-field stimulus testing was greater in treated eyes compared with untreated eyes at all six follow-up visits, and some patients exhibited over 10,000-fold improvements in retinal sensitivity. For more information, see the study results here. In addition, the FDA granted Regenerative Medicine Advanced Therapy designation to ATSN-101. Atsena has also received orphan drug designation from the FDA for ATSN-101 for the treatment of LCA1.

  • OKYO Pharma announced the last patient of a planned 240-patient double-blind placebo-controlled Phase 2 clinical trial of OK-101 to treat DED has completed the 12-week OK-101 dosing study. In addition, data analysis plans for the trial have now been finalized and submitted to the FDA for feedback, in anticipation of database lock, subsequent data analysis and reporting of top-line findings on OK-101. The protocol for the study includes two prespecified primary endpoints and a number of secondary endpoints. Top-line efficacy and safety data is on track to be released this month. For more details on the trial, click here. 

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.