Phase 1/2a results for suprachoroidal wet AMD treatment

Clearside Biomedical announced positive results from its Phase 1/2a clinical trial of suprachoroidal CLS-AX (axitinib injectable suspension) for treatment of wet AMD. According to the company’s press release, the primary safety endpoint was met in all cohorts with no treatment-related or serious adverse events. CLS-AX is a tyrosine kinase inhibitor that the company stated directly inhibits VEGF receptors 1, 2, and 3. In cohorts 3 and 4, at the 3-month timepoint, 73% of patients saw a reduction in treatment burden from their average monthly injections prior to CLS-AX treatment. According to data from the ongoing extension study, 88% of patients in these cohorts were free from supplemental anti-VEGF injections at month 5 and 75% at month 6.

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Enrollment complete for two Phase 2 trials investigating dry eye therapies disease

Aramis Biosciences announced that it has completed enrollment of 207 patients for its Phase 2 proof-of-concept clinical trial for A197, a topical, first-in-class immunomodulatory agent for treatment of dry eye disease. This trial is multicenter, double masked, randomized, and vehicle controlled to evaluate the safety and tolerability of A197 and to evaluate two doses. Topline results are expected within the first quarter of 2023. A separate Phase 2 study for another dry eye therapy being investigated by Allysta Pharmaceuticals has also completed patient enrollment. The study being conducted for ALY688 Ophthalmic Solution has enrolled and randomized 922 subjects. ALY688 Ophthalmic Solution is described by the company as a “novel first-in-class peptide with broad anti-inflammatory and corneal epithelial regenerative properties.”

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Phase 2b study for drug-eluting contact lens begins

MediPrint Ophthalmics is beginning a Phase 2b clinical study for its drug-eluting contact lens. This study is designed to treat mild to moderate glaucoma and ocular hypertension with LL-BMT1, a contact lens that elutes bimatoprost. The study follows the successful SIGHT-1 trial that showed favorable safety, tolerability, and sustained efficacy.

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Healthcare company acquires biopharmaceutical company developing ophthalmic treatments

Oyster Point Pharma announced that it entered into a definitive agreement for its acquisition by Viatris. This acquisition, according to the company’s press release, forms the foundation of Viatris’ new ophthalmology franchise. Oyster Point Pharma is the maker of TYRVAYA (varenicline) and has three drug candidates in its pipeline.

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Development and commercialization licensing agreement

Ocuphire Pharma announced that it entered into an exclusive licensing agreement with FamyGen Life Sciences for development and commercialization of Nyxol (phentolamine ophthalmic solution), which is being investigated for three indications. These indications include reversal of pharmacologically induced mydriasis, presbyopia, and dim light or night vision disturbances. This agreement would include the U.S., Europe, Japan, India, China, and other global markets, according to the company’s press release. Ocuphire plans to submit an NDA to the FDA for Nyxol for reversal of mydriasis within the fourth quarter of this year.

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ASOA podcast features dry eye info for the practice

Earlier this year, ASOA EyeTalks Radio, a practice management resource that features experienced ophthalmic practice administrators and subject matter experts, hosted “Q&A: Dry Eye in Practice … Gotta Squeeze a Few Lemons to Make Lemonade.” In the episode, which was sponsored by Sight Sciences, Jim Sluck, vice president of marketing for TearCare, and Matt Jensen, CEO of Vance Thompson Vision, discussed the topic of activating dry eye in practice. Listen to this episode and other ASOA EyeTalks Radio episodes.

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ASCRS news and events

• 2023 ASCRS Educator Award: ASCRS is accepting nominations for its Educator Award, which will be given at the 2023 ASCRS Annual Meeting. Submit a nomination here.
• 2023 ASCRS Annual Meeting: Hotel blocks in San Diego, California, for the Annual Meeting are open now. Early bird registration opens November 21. Learn more.
• EyeWorld: A new Online Exclusive is available on www.EyeWorld.org on the topic of management of recurrent corneal erosions.

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Research highlights

• A retrospective study published in the Journal of Cataract & Refractive Surgery sought to determine the effect of femtosecond laser cutting parameters on small incision lenticule extraction (SMILE). The research evaluated cap thickness, interface light scattering, and visual and refractive outcomes. The study included 58 right eyes that received SMILE with a cap thickness of 130 μm. The eyes were divided into two groups for analysis: those that received a 165 nJ pulse energy and 4.5 μm spot separation (Group 1, n=36) and those that received a 125 nJ pulse energy and 4.2 μm spot separation (Group 2, n=22). At 3 months postop, cap thickness was 138.9±6.2 μm in Group 1 and 149.4±3.5 μm in Group 2. There was no scattering in 33.3% in Group 1 and 86.4% in Group 2. Eyes in Group 2 were also more likely to be within 0.5 D of target and have a UCDVA of 20/20 or better (95.5% and 86.4%, respectively, in Group 2, and 83.3% and 69.4%, respectively, in Group 1).
• A multicenter retrospective cohort study published in the journal Ophthalmologylooked at the efficacy of MIGS with and without concurrent phacoemulsification cataract surgery. The research was based on IRIS Registry data for patients who had the XEN Gel Stent (Allergan), endoscopic cyclophotocoagulation (ECP), goniotomy, or canaloplasty between 2013 and 2019. The main outcome measures were reoperation rate, mean IOP, mean visual acuity, postop complications, predictors of reoperation, and reoperation procedure type. Of the 79,363 included in the study, 15,118 eyes had a standalone MIGS, procedure while 64,245 had MIGS combined with cataract surgery. The researchers found that those who had the combined procedures had a lower reoperation rate. Combined ECP had a reoperation rate of 3%, XEN 19%, and goniotomy/canaloplasty 6%, while reoperation rates for these procedures when they were standalone were 15%, 24%, and 24%, respectively. Predictors for a higher reoperation rate were black race, older age, moderate to severe glaucoma, higher baseline IOP, and glaucoma subtype. The authors observed that patients who had a standalone MIGS had a more substantial decrease in mean IOP compared to combined procedures.

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