First patient treated in Phase 2 study of investigational emulsion for glaucoma

Skye Bioscience has treated the first patient enrolled in its Phase 2 study of SBI-100 ophthalmic emulsion for treatment of primary open-angle glaucoma or ocular hypertension. According to the company’s press release, SBI-100 is a synthetic “prodrug of tetrahydrocannabinol able to bind and activate CB1 receptors.” The company stated that prior studies have shown “activation of the CB1 receptor using THC” can reduce IOP. In Phase 1 studies, the company reported that the emulsion was safe and reduced IOP by a mean of 23.9% in a subset of healthy volunteers who had a higher baseline IOP of more than 17 mm Hg. In the Phase 1 trial, SBI-100 was detected in the blood, but the company reported that no THC and “minimum amounts” of the psychoactive metabolite of the drug were detected, which the company stated supports minimal systemic side effects.” The Phase 2 study is evaluating safety and efficacy of two SBI-100 concentrations vs. placebo with twice daily dosing for 14 days.

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FDA issues complete response letter for dry eye drug NDA

Aldeyra Therapeutics received a complete response letter from the FDA for its reproxalap New Drug Application. According to the company’s press release, the FDA stated in the letter that the NDA did not show “efficacy in treating ocular symptoms associated with dry eyes” and stated that an additional study to demonstrate the positive effect of the treatment on ocular symptoms was needed. The company noted that this month, it submitted a Special Protocol Assessment from a dry eye disease chamber crossover clinical trial to the FDA and expects feedback from the administration in December. Topline results from this trial, if conducted, would be expected within the first half of 2024 with the potential for an NDA resubmission expected in the first half of 2024 as well, pending FDA feedback and positive results from the proposed trial, the company reported.

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FDA meeting minutes issued for BLA submissions of ophthalmic formulation of bevacizumab

Outlook Therapeutics announced that it received the minutes from its Type A meeting with the FDA regarding a Complete Response Letter that was issued earlier this year for its Biologics License Application for ONS-5010. The company is developing ONS-5010 as the potential first ophthalmic formulation of bevacizumab for treatment of retinal diseases, like wet AMD. According to the company, the FDA requires an additional study to support ONS-5010’s BLA; this will be a non-inferiority, 3-month study evaluating ONS-5010 vs. ranibizumab in treatment naïve patients. Outlook Therapeutics is working with the Division of Ophthalmology to design this study to meet the FDA’s requirements. The company thinks this study is on track for completion in 2024, with resubmission expected by the end of 2024.

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Phase 1/2 trial to begin for first-in-class dry AMD therapy

Inflammasome Therapeutics announced that it was granted approval to begin a Phase 1/2 trial of its investigational therapy for treatment of dry AMD. According to the company’s press release, the therapy is based on a new class of inflammasome inhibitor drugs called kamuvudines. Participants in the trial will receive a sustained-release implant that will release the drug over a 3-month period. Kamuvudines, according to the company, have been shown effective in pre-clinical models of geographic atrophy.

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Company merger news

LENZ therapeutics and Graphite Bio have entered into a definitive merger agreement to combine the companies in an all-stock transaction. According to the press release regarding this news, the lead programs of this new combined company will focus on presbyopia. The merger is subject to stockholder approval, SEC registration statement, and closing conditions.

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ASCRS news and events

• ASCRS Annual Meeting: Registration for the 2024 ASCRS Subspecialty Day and ASCRS Annual Meeting is now open. Learn more about this premier educational and networking event for anterior segment surgery here.
• A Taste of ASCRS: This nine-section CME program is available on demand. Learn more about the program.

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Research highlights

• A retrospective consecutive case series published in the Journal of Cataract & Refractive Surgery sought to investigate the effect of corneal curvature (K) on the accuracy of 8 IOL formulas in highly myopic eyes. The study evaluated 302 eyes from 302 patients. The Emmetropia Verifying Optical (EVO) 2.0, Kane, and Radial Basis Function (RBF) 3.0 formulas resulted in the lowest mean absolute error (MAE) and root mean-square absolute prediction error (RMSAE) and the highest percentage of eyes within 0.5 D in the flat K (43 D) and steep K (45 D) groups. The authors reported that the Hoffer QST had the lowest median absolute error (MedAE), RMSAE, and highest percentage of eyes within 0.5 D in the normal K group (between 43–45 D). When the axial length was 28 mm or less, all formulas had close RMSAE values in the flat K group, according to the paper, but when axial length was more than 28 mm or more, the RBF 3.0 had the lowest MAE, MedAE, and RMSAE in all subgroups. The authors concluded that the EVO 2.0, Kane, and RBF 3.0 formulas were the most accurate in highly myopic eyes with flat or steep Ks, while the Hoffer QST performed better in the setting of a high axial length and normal K values. When axial length was more than 28 mm, RBF 3.0 was most accurate, independent of corneal curvature.
• A single-center, retrospective, longitudinal study evaluated whether repeated anti-VEGF injections are associated with glaucoma progression. The study was comprised of patients with bilateral glaucoma who received 8 or more intravitreal injections in one eye during the study period and who had two or more RNFL thickness measurements at least 12 months apart. The primary outcome was absolute RNFL thickness change in the injected eye compared to the uninjected eye. The authors found that repeated intravitreal injections did not seem to be associated with accelerated glaucoma progression, but they stated that repeated longer-term follow-up studies are needed. The research is published in Clinical Ophthalmology.

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Product news

• Lupin received FDA approval for its Abbreviated New Drug Application for bromfenac ophthalmic solution, 0.07%, to market as a generic equivalent to Prolensa Ophthalmic Solution (Bausch + Lomb), 0.07%.
• Harrow completed the transfer of the New Drug Application for TRIESENCE (triamcinolone acetonide injectable suspension), 40 mg/mL, after agreeing in December 2022 to obtain the commercial rights from Novartis.

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