Equinox Science LLC

An EyePoint spokesperson told Fierce that the issues raised in the FDA's warning letter are confined to the manufacturing of Yutiq and should not affect other products under development, such as the company’s lead candidate Duravyu. After hitting a regulatory snare with its lead drug candidate earlier this year, ophthalmology specialist EyePoint Pharmaceuticals has run up against another spot of trouble with the FDA.EyePoint was handed an FDA warning letter at its facility in Watertown, Massachusetts, in July, according to a notice from the agency posted Tuesday. EyePoint received the more serious reprimand after previous receipt of a Form 483, which the company responded to March 7.The FDA’s citations, uncovered during a February inspection, include batch discrepancies, lackluster written procedures and more.Many of the regulator’s complaints come down to the EyePoint-developed implant Yutiq, which contains the corticosteroid fluocinolone acetonide. EyePoint recently sold certain rights for the drug-device combo—which was approved in the U.S. in 2018—to Alimera Sciences in an $82.5 million deal. With an emphasis on quality and safety, EyePoint is “committed to fully resolving” all of the FDA’s observations, a company spokesperson told Fierce Pharma over email. She pointed out that the issue is confined to the manufacturing of Yutiq and should not affect other products under development, such as the company’s lead candidate Duravyu.“EyePoint has been communicating with the FDA regarding actions it has taken and is taking to address findings identified in the Warning Letter, and we have applied resources from across the company to implement corrective actions and process improvements related to the observations,” she said.The FDA’s first complaint on EyePoint’s manufacturing operations revolved around the company’s failure to root out production inconsistencies. Agency investigators chided EyePoint for failing to investigate an atypically high release rate value for drug cores during the release testing of a particular Yutiq batch.Further, EyePoint’s own probes failed to identify proper solutions to keep its manufacturing on track, the FDA said. The regulator pointed to “three roof leaks,” which caused moisture to seep into “environmentally controlled manufacturing areas”—a problem that the investigators said stretched back to July 2023.EyePoint told the FDA it would work with the owner of the building to assess the space’s roof. But the company did not establish regular facility inspections to confirm an “appropriate state of maintenance and continued suitability to manufacture drug products,” the FDA said.EyePoint has also struggled with written procedures at its Watertown plant, the FDA went on to say.The FDA specifically called out subpar performance studies of Yutiq that “did not scientifically demonstrate blend uniformity” in the final product.Additionally, EyePoint’s operations and engineering organizations failed to create statistical process control charts to keep track of the company’s manufacturing procedure performance. The various charts that EyePoint only generated during the FDA’s inspection “identified four previously unrecognized adverse trends … that required investigation per your procedure,” the FDA stated in its warning letter.Lastly, the FDA scolded EyePoint for subpar visual inspections during its production process, noting that the company’s methodology “lack[ed] action levels for significant … defects which will require investigation.”The regulatory wrist slap comes after EyePoint in May reported that its primary pipeline asset, Duravyu, failed to sufficiently improve patient scores on the Diabetic Retinopathy Severity Scale. The trial miss came from EyePoint’s phase 2 PAVIA study in patients with non-proliferative diabetic retinopathy.At the time, Mizuho analyst Graig Suvannavejh, Ph.D., called the result a “significant disappointment” for EyePoint and said he expected “questions to rise to the surface” regarding Duravyu’s prospects in diabetic macular edema and wet age-related macular degeneration (AMD), which are also being targeted by the company.Duravyu is an intravitreal, sustained release insert that delivers the VEGFR/PDGFR tyrosine kinase inhibitor vorolanib to the eye. EyePoint licensed vorolanib from Equinox Science in early 2020.Despite a few hiccups for EyePoint this year, Mizuho’s Suvannavejh seemed more optimistic about the company by the middle of August. In a recent note to clients, Suvannavejh wrote that the analyst team still has “continued enthusiasm” around EyePoint given the ripe potential for Duravyu in wet AMD, where the implant could become a standard of care.EyePoint stressed during its second-quarter earnings call that executing on Duravyu’s phase 3 study in wet AMD was its top priority, according to the Mizuho note. 

7月12日，贝达药业与EyePoint Pharmaceuticals, Inc.合作开发的EYP-1901玻璃体内植入剂获得国家药品监督管理局签发的药物临床试验批准通知书,拟用于治疗既往接受过抗血管内皮生长因子（VEGF）玻璃体内注射的湿性（新生血管性）年龄相关性黄斑变性（wAMD）患者。 wAMD患者因异常血管侵入眼部黄斑区导致视力受损甚至失明，是老年人群低视力乃至失明的主要原因。EYP-1901通过抑制血管内皮生长因子受体（VEGFR）、血小板衍化生长因子受体（PDGFR）的功能，进而抑制眼部新生血管的形成，降低新生血管的通透性，减少血管渗漏。wAMD患者在接受短效抗VEGF药物治疗的疗效稳定后，EYP-1901通过Durasert E™缓释给药技术可以使伏罗尼布以一种可控且可耐受的方式持续地在眼部释放，延长抗VEGF注射治疗周期，提高患者治疗依从性，减轻医疗负担。 EYP-1901玻璃体内植入剂美国wAMD适应症Ⅱ期临床研究（DAVIO 2）达到所有主要终点和次要终点，表现优异，开发前景可观。其活性成份伏罗尼布是新一代多靶点酪氨酸激酶VEGFR、PDGFR抑制剂，贝达药业拥有该化合物的自主知识产权。由贝达药业申报的相同活性成份的1类创新药伏罗尼布片已于2023年6月获批上市用于肾癌治疗。 贝达药业副总裁王三虎表示，此次获批是伏罗尼布在眼科领域又一次新的探索，美国Ⅱ期研究的积极结果让我们对推进EYP-1901玻璃体内植入剂研究充满信心。随着人口老龄化程度的加剧，期待EYP-1901玻璃体内植入剂能够更好地满足老年人群的眼科临床需求，提高患者生活质量。 贝达药业董事长丁列明博士表示，贝达药业成立至今，一直致力于创新药物的研发，很高兴看到EYP-1901玻璃体内植入剂获批临床，这是对贝达研发管线的补充和拓展，目前该项目在中美两国有序推进，后续贝达药业将集中资源，全力推进wAMD适应症在中国的临床研究，期待能早日获批上市，为我国眼科患者提供更好的治疗手段。 关于EYP-1901 2022年5月4日，贝达药业与EyePoint签订了EYP-1901扩大合作协议，贝达药业取得在中国（包括香港、澳门和台湾）区域开发和商业化EYP-1901的独家权利，EyePoint保留EYP-1901在全球其他地区的眼科权利。同时，贝达药业控股子公司Equinox Sciences, LLC独家授权EyePoint在中国（包括香港、澳门和台湾）区域外开发伏罗尼布用于所有局部给药的眼科适应症。

限时免费报名中 刚刚，贝达药业发布公告，公司与 EyePoint Pharmaceuticals,Inc. 共同申报的EYP-1901玻璃体内植入剂湿性年龄相关性黄斑变性（wAMD）适应症药物临床试验申请已获得NMPA批准开展。 伏罗尼布是贝达药业研发的，具有全新化学结构的新一代多靶点酪氨酸激酶血管内皮生长因子受体（VEGFR）/血小板衍化生长因子受体（PDGFR）抑制剂，可抑制肿瘤血管生成及生长，用于治疗病理性血管生成性疾病。 2020年2月，贝达药业控股子公司 Equinox Sciences,LLC 与EyePoint签署了《独占许可协议》，独家授权EyePoint在中国（包括香港、澳门和台湾）区域外以局部给药方式开发酪氨酸激酶抑制剂伏罗尼布用于治疗湿性年龄相关性黄斑变性（w-AMD）、糖尿病视网膜病变（DR）和视网膜静脉阻塞（RVO）。 EYP-1901玻璃体内植入剂通过EyePoint专有的可生物降解的缓释技术DurasertETM将伏罗尼布注射进入玻璃体内，使伏罗尼布以可控且可耐受的方式持续地在眼部释放。EYP-1901通过抑制VEGFR、PDGFR的功能，进而抑制眼部新生血管的形成，降低血管的通透性，减少血管渗漏。 2021年，EyePoint在美国启动针对wAMD适应症的I期临床研究DAVIO，目前DAVIO研究已经完成；针对wAMD适应症的II期临床研究DAVIO2已达到所有主要终点和次要终点。贝达药业和EyePoint联合申报的病理性近视脉络膜新生血管（pmCNV）适应症临床试验申请已于2023年7月获得NMPA批准开展。 2022年5月4日，贝达药业与EyePoint签署《扩大许可协议》，取得在中国（包括香港、澳门和台湾）区域开发和商业化EYP-1901的独家权利。 截至本公告披露日，全球范围内抗VEGF类眼科药物中尚无EYP-1901同类小分子植入剂品种获批上市。