The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).

Start Date25 May 2018

Sponsor / Collaborator

Allergan Ltd. (Ireland)

NCT03335852 / CompletedPhase 1

Evaluation of Safety and Systemic Pharmacokinetics After Abicipar Pegol (AGN-150998) Intravitreal Injections in Japanese Patients With NEovascular Age-Related Macular Degeneration (PINE Study)

This study will evaluate the safety and to characterize the systemic pharmacokinetics of free and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly intravitreal injections of abicipar in Japanese patients with neovascular age-related macular degeneration (AMD).

Start Date28 Nov 2017

Sponsor / Collaborator

Allergan Ltd. (Ireland)

NCT02859766 / CompletedPhase 1

Evaluation of Safety and Systemic Pharmacokinetics After Single and Repeat Doses of Abicipar Pegol (AGN-150998) Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration

This study will evaluate the safety and characterize the systemic pharmacokinetics (PK) of free and vascular endothelial growth factor (VEGF)-bound abicipar following single and multiple intravitreal injections of abicipar pegol in treatment-naïve patients with neovascular age-related macular degeneration (AMD).

Start Date07 Dec 2016

Sponsor / Collaborator

Allergan Ltd. (Ireland)

100 Clinical Results associated with Abicipar pegol

100 Translational Medicine associated with Abicipar pegol

100 Patents (Medical) associated with Abicipar pegol

Literatures (Medical) associated with Abicipar pegol

02 Oct 2024·Expert Opinion on Drug Metabolism & Toxicology

Intraocular drugs: pharmacokinetic strategies and the influence on efficacy and durability

Review

Author: Stewart, Michael W.

INTRODUCTION:

The modern treatment of chorioretinal vascular diseases follows the recent development and rapid adoption of drugs that inhibit vascular endothelial growth factor (VEGF). All anti-VEGF drugs are delivered intravitreally, with clinical behavior, including efficacy, durability, and safety, largely determined by their pharmacokinetic properties.

AREAS COVERED:

Properties of these new drugs include additional binding targets (placental growth factor (PlGF) and angiopoietin 2 (Ang 2)), binding affinity, potency, intravitreal half-life, and increased molar dose. A PubMed search for 'pharmacokinetics of anti-VEGF drugs' was performed from 2000 to 2023. Relevant studies were reviewed and referred to in the manuscript.

EXPERT OPINION:

Early developers concentrated on improving efficacy, but since maximum efficacy with VEGF inhibition has been reached, development has pivoted to extending the duration of action. Durability strategies include inhibiting additional pathways (faricimab), increasing molar dose (abicipar, brolucizumab, faricimab, and aflibercept 8 mg), and prolonging the intravitreal half-life (abicipar and KSI-301). Recent phase 3 trials demonstrated modest improvements in durability, but failures that might be attributed to these strategies (conjugation and manufacturing processes) have occurred. Future drug development focuses on extending duration of action with implantable reservoirs (ranibizumab port delivery system), sustained release devices (tyrosine kinase inhibitors), and gene therapy.

01 Jul 2023·Archivos de la Sociedad Espanola de Oftalmologia

Differential diagnosis of endophthalmitis after intravitreal drug injection for age related macular degeneration: sterile vs. infectious

Review

Author: Gallego-Pinazo, R ; Dolz-Marco, R ; Montolío-Marzo, E ; Vidal-Oliver, L ; Montolío-Marzo, S

The recent release of brolucizumab and the development of new antiangiogenic molecules as abicipar pegol has increased the interest towards inflammatory complications after intravitreal drug injection. Those drugs are associated to a higher rate of inflammatory adverse events compared to classic drugs. In this context it is essential to differentiate between sterile and infectious cases for a fast and effective treatment. The clinical similarities between infectious and sterile cases, the high rate of culture negative patients and the heterogeneity in the terminology used are obstacles for a correct diagnosis and report of these complications. Sterile cases appear early after the injection, before 48 h; or 20 days after in brolucizumab-related vasculitis cases. Infectious cases show up around the third day after injection and up to a week after it. A severe visual impairment, severe pain, severe hyperemia, hypopyon and a more severe intraocular inflammatory process are signs of a likely infectious origin. If the cause of the inflammation is uncertain we must follow up the patient closely or "tap and inject" antimicrobial agents in order to prevent the eventual complications of an infectious endophthalmitis. On the other hand, sterile endophthalmitis might be observed in mild cases or treated with steroids according to the severity of the inflammation.

01 Jan 2023·Vestnik oftalmologii

[Modern trends in anti-VEGF therapy for age-related macular degeneration].

Article

Author: Alkharki, L ; Budzinskaya, M V ; Plyukhova, A A

Age-related macular degeneration (AMD) develops in people aged 50 years and older, its pathogenesis involves progressive destruction of the retinal pigment epithelium and Bruch's membrane. There are eight currently known anti-VEGF drugs for treating the neovascular form of AMD, four of them have already been registered and are used in clinical practice. The first registered drug was pegaptanib, which selectively blocks VEGF₁₆₅. Subsequently, a molecule with a similar mechanism of action was developed and named ranibizumab, which is a humanized monoclonal Fab fragment; it was specifically designed for ophthalmology. Its advantage over pegaptanib was neutralization of all active VEGF-A isoforms. Aflibercept and conbercept are recombinant fusion proteins that act as soluble decoy receptors for VEGF family proteins. Phase III data from the VIEW 1 and 2 studies showed that intraocular injections (IVI) of aflibercept every 1 or 2 months for a year resulted in comparable functional outcomes to monthly IVI of ranibizumab for one year. The next molecule for anti-VEGF therapy that showed effectiveness was brolucizumab - a single-chain fragment of a humanized antibody that binds with high affinity to various VEGF-A isoforms. Simultaneously with studying brolucizumab, another study was conducted involving Abicipar pegol, but that drug showed a high rate of complications. The latest drug registered for the treatment of neovascular AMD is faricimab. The molecule of this drug is a humanized immunoglobulin G antibody that acts on two key points of angiogenesis: VEGF-A and angiopoietin-2 (Ang-2). Thus, the strategy for advancing anti-VEGF therapy lies in the development of molecules with greater efficiency (better effect on newly formed vessels leading to resorption of exudate in the retina, under the neuroepithelium and under the retinal pigment epithelium), which allows not just to preserve vision, but to also significantly improve it when there is no macular atrophy.

News (Medical) associated with Abicipar pegol

11 Jan 2023

·www.fiercebiotech.com

JPM23, Day 3: Ionis CEO concedes PCSK9 ship may have sailed; Nektar forges ahead after bempeg blowup

While M&A deals may have dried up on Day 2, we're still holding out hope for a JPM-defining blockbuster acquisition. We're off for another day of the J.P. Morgan Healthcare Conference. The flood of licensing agreements may have slowed, but there's still plenty of action to come as companies make pitches to their peers, investors and industry watchers. Some notable highlights from yesterday included Sage Therapeutics setting out its stall for depression drug zuranolone, while Karuna Therapeutics suggested that it didn’t need to take advantage of swirling acquisition rumors to scale up its hotly anticipated schizophrenia drug. And while M&A deals may have dried up on Day 2, we're still holding out hope for a JPM-defining blockbuster acquisition. If that happens, you'll hear about it right here. Our Day 1 conference tracker is available here, and all the Day 2 action is wrapped here. Fierce Pharma’s take on the action so far can be found here and here. 6:05 p.m. ET: It appears that Ionis’ PCSK9 hopes are dimming. CEO Brett Monia told Fierce Biotech in an exclusive interview that the recently returned drug does not fit the company’s plans. The med, ION449, was returned to Ionis from AstraZeneca following a phase 2 data readout last year. The prospects of the company’s factor XI med, fesomersen, are more promising, however. Story 1:08 p.m. ET: Annexon Biosciences CEO Douglas Love said the company is giving itself "two ways to win” in the upcoming pivotal phase 2/3 trial for Huntington’s disease therapy ANX005, during his remarks at the JPM Wednesday morning. Love previewed the year ahead, which includes initiating ANX1502 in phase 1 studies for autoimmune indications, completing phase 3 enrollment for ANX005 in Guillain-Barre syndrome (GBS) and initiating the phase 2/3 trial for Huntington’s disease. Story 12:50 p.m. ET: Nektar Therapeutics is forging ahead with its existing pipeline, months after the failure of bempeg crumbled a multi-billion dollar deal with Bristol Myers Squibb. The company’s comeback story hinges mainly on two clinical-stage assets, one of which is a part of a collaboration with Lilly. A readout for that drug, rezpeg, is expected from a phase 2 trial in patients with lupus within the first half of the year, with CEO Howard Robin saying at the J.P. Morgan Healthcare Conference that he hopes the data is ready “sooner rather than later.” Nektar’s remaining cancer opportunity rests solely on NKTR-255, an IL-15 agonist being teed up as a combo med for a number of cancer treatments. Story 12:05 p.m. ET: Novartis’ deal with Molecular Partners at the end of 2021 not only secured the biotech a potential $560 million biobucks payday in the future, it also cemented the reputation of radioligands as a “truly hot” therapy area for investors. At least, that’s how Molecular Partners CEO Patrick Amstutz, Ph.D., tells it. “It’s hot because companies like Novartis have presented data, especially in prostate [cancer],” Amstutz told a JPM session. “So amazing results, and really opening this field for additional treatment.” With radioligand programs progressing, as well as moving its first T cell engager into the clinic “literally any day” now, it’s a good thing the biotech has plenty of cash in the bank. “We’re well capitalized until 2026, not something we should take for granted in these stormy conditions,” the CEO said. One outlier is Abicipar, a late-stage eye drug that was initially licensed out to Allergan and ultimately returned to Molecular Partners a decade later. The Swiss biotech is still on the lookout for a suitable partner, said Amstutz, who claimed the drug produced “beautiful data” in a late-stage trial for wet age-related macular degeneration. FDA concerns around inflammation put the breaks on approval hopes, but the CEO said the company has since had a “breakthrough” that the inflammation was caused by the type of syringe used. “It seems we have solved the problem to have less inflammation,” Amstutz said. “We will not pursue this in Molecular Partners but we are in discussions to see if there is a path forward with this drug, especially as it would only need one additional safety trial to get it approved.” While the conference is notorious for its dealmaking and partnership announcements, Takeda’s head of GI therapeutics Chinwe Ukomadu, M.D., Ph.D., told Fierce Biotech on the sidelines that the Japanese pharma is always looking for potential collaborators. “We don’t wait for JPM,” Ukomadu said. “We’re having conversations all along with the companies. We see them on our team meetings, Zoom meetings, but there’s something unique about getting to sit with them in person now.” The moral of the story? To be successful, Big Pharmas can’t be too inward looking. Under the guidance of R&D head Andy Plump, M.D., Ph.D., Takeda has built out 90% of its pipeline assets in fewer than 10 years, a feat only possible via collaboration.

Phase 2AcquisitionPhase 3

09 Aug 2021

·endpts.com

AbbVie hands back headline drug in $63B Allergan buyout to Molecular Partners after FDA rejection. What's next?

One of the programs that headlined AbbVie’s $63 billion acquisition of Allergan is being returned to its developers after an FDA rejection last year. AbbVie has terminated the license and collaboration agreement it had with Switzerland’s Molecular Partners for abicipar, the companies announced Monday, an experimental drug aimed to treat neovascular age-related macular degeneration and diabetic macular edema. Abicipar was rejected by the FDA in June 2020 due to what AbbVie said was an unfavorable benefit-risk ratio, according to its description of the CRL. Molecular Partners’ stock $MOLN was down about 4% on the Swiss stock exchange in the wake of Monday’s news. In order to determine next steps for the program, Molecular Partners said in a release that it will establish a “special committee.” Company spokesperson Seth Lewis told Endpoints News in an interview that the committee will likely be composed primarily of internal staffers but may bring on outside expertise “as needed.” Lewis further emphasized that future plans are still in the nascent stage, given that Molecular Partners only received notification of the termination Monday. The company has yet to receive all the materials associated with the program, with Lewis saying Allergan had essentially owned the program outright and made all major decisions. While Molecular Partners had been kept informed of the program’s progress, Lewis attempted to distance the biotech from Allergan, saying the relationship between the companies has “ebbed and flowed” in the years since licensing abicipar back in 2011. Lewis stressed that since that time, Molecular Partners had built out a portfolio largely unrelated to ophthalmology. Other programs are not expected to be affected by the termination, as the release noted that the companies will continue partnering on ophthalmic indications. Abicipar had been expected to play a big part in the famed Allergan buyout and challenge the Roche drug Lucentis and the Regeneron giant Eylea, with former Allergan CEO Brent Saunders saying back in May 2019 the program was one of four “expected” to gain FDA approval. The candidate had passed two Phase III tests a year earlier, as Allergan touted both eight- and 12-week regimens. But those studies also flagged that the incidence of intraocular inflammation proved higher in patients on abicipar than those on Lucentis, which regulators took issue with in the CRL, Lewis said. Allergan had conducted a separate open-label, single-arm study around the same time as the Phase III trials, showing new manufacturing processes appeared to have led to a lower rate of inflammation. That study was not included in the pivotal program, however. The intraocular inflammation rate in this trial was 8.9%, or around numerically half the rate observed in prior Phase III studies, which hovered around 15%. Lewis said the threshold the FDA is looking for is around 5%, and another pivotal study looking at further lowered rates could be in the cards. “If you think about the history of Allergan, they were a great commercial company when we did the deal with them back in 2011, and it was very exciting to be able to do that, but their knowledge of biological manufacturing wasn’t that great at the time,” Lewis told Endpoints. “The knowledge and increased efficacy of process that’s been built up over that time should allow for continued improvements.”

Acquisition

09 Aug 2021

·www.globenewswire.com

Molecular Partners to Regain Global Rights to Abicipar

ZURICH-SCHLIEREN, Switzerland, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to Art. 53 LRMolecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin® therapeutics, announced today the receipt of notification from its partner, AbbVie Inc., regarding its termination of the license and collaboration agreement for the investigational drug abicipar pegol for the treatment of neovascular age-related macular degeneration (nAMD) and Diabetic Macular Edema (DME). As such, Molecular Partners will regain the development and commercial rights of abicipar on a worldwide basis. “There remains a significant unmet medical need for patients living with nAMD and DME, and we remain confident in abicipar’s potential to offer these patients a differentiated treatment option over existing therapies,” said Patrick Amstutz, Chief Executive Officer of Molecular Partners. “Our focus for this program will be determining the best path to value creation within the context of our expansive portfolio of antiviral and immuno-oncology therapies in development.” Molecular Partners will form a special committee to evaluate the program and determine appropriate next steps. In addition, Molecular Partners and AbbVie will continue their ongoing discovery alliance, in which AbbVie will continue to evaluate additional DARPin® candidates for ophthalmic indications. The return of the abicipar program is not expected to impact Molecular Partners’ financial outlook for 2021 or previously issued guidance. Abicipar is a long-acting anti-VEGF DARPin® molecule which was invented by Molecular Partners and initially licensed to Allergan in 2011. The program has been through two positive Phase 3 studies, CEDAR and SEQUOIA, which supported the non-inferior efficacy of the abicipar quarterly dosing regimen to maintain vision gains with more than 50 percent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year. With the acquisition of Allergan by AbbVie, the rights to abicipar were transferred to AbbVie. In June 2020, AbbVie received a Complete Response Letter to the Biologics License Application for abicipar pegol, indicating that the rate of intraocular inflammation observed following administration of Abicipar pegol resulted in an unfavorable benefit-risk ratio in the treatment of nAMD (AMD), and that additional work would be required to demonstrate a lower rate of ocular inflammation than what was previously seen in the Phase 3 studies. About Molecular Partners AG Molecular Partners AG is a clinical-stage biotech company developing DARPin® therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. The Company has formed partnerships with leading pharmaceutical companies to advance DARPin® therapeutics in the areas of ophthalmology, oncology and infectious disease, and has compounds in various stages of clinical and preclinical development across multiple therapeutic areas. ; Find us on Twitter - @MolecularPrtnrs Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, “would” and similar expressions, and are based on Molecular Partners AG’s current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Some of the key factors that could cause actual results to differ from our expectations include our plans to develop and potentially commercialize our product candidates; our reliance on third party partners and collaborators over which we may not always have full control; our ongoing and planned clinical trials and preclinical studies for our product candidates; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; the extent of clinical trials potentially required for our product candidates; the clinical utility and ability to achieve market acceptance of our product candidates; our plans and development of any new indications for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property position; our ability to identify and in-license additional product candidates; and other risks and uncertainties that are described in the Risk Factors section of Molecular Partners’ Registration Statement on Form F-1 filed with Securities and Exchange Commission (SEC) on June 14, 2021 and other filings Molecular Partners makes with the SEC. These documents are available on the Investors page of Molecular Partners’ website at . Any forward-looking statements speak only as of the date of this press release and are based on information available to Molecular Partners as of the date of this release, and Molecular Partners assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. For further details, please contact: Investors:Seth Lewisseth.lewis@molecularpartners.comTel: +1 781 420 2361 Media:Shai Biran, Ph.D.shai.biran@molecularpartners.comTel: +1 978 254 6286 Thomas Schneckenburger, European IR & Mediathomas.schneckenburger@molecularpartners.comTel: +41 79 407 9952

AcquisitionLicense out/in

100 Deals associated with Abicipar pegol

External Link

KEGG	Wiki	ATC	Drug Bank
D11517	-	-	DB12258

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Wet Macular Degeneration	NDA/BLA	EU	-	-
Age Related Macular Degeneration	Phase 3	US	Allergan Ltd. (Ireland)	25 Jun 2015
Age Related Macular Degeneration	Phase 3	JP	Allergan Ltd. (Ireland)	25 Jun 2015
Age Related Macular Degeneration	Phase 3	AR	Allergan Ltd. (Ireland)	25 Jun 2015
Age Related Macular Degeneration	Phase 3	AU	Allergan Ltd. (Ireland)	25 Jun 2015
Age Related Macular Degeneration	Phase 3	AT	Allergan Ltd. (Ireland)	25 Jun 2015
Age Related Macular Degeneration	Phase 3	BR	Allergan Ltd. (Ireland)	25 Jun 2015
Age Related Macular Degeneration	Phase 3	CA	Allergan Ltd. (Ireland)	25 Jun 2015
Age Related Macular Degeneration	Phase 3	CL	Allergan Ltd. (Ireland)	25 Jun 2015
Age Related Macular Degeneration	Phase 3	CO	Allergan Ltd. (Ireland)	25 Jun 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03539549 (CTgov)	Phase 2	Wet age-related macular degeneration	124	Abicipar pegol	pqyorxwdfw(aiincqwniz) = tibdfcreor vretvvivog (nvcxijuvbb, krobltksqs - kfijiujbur) View more	-	03 Aug 2020
NCT02462486 (SEQUOIA, CTgov)	Phase 3	Age Related Macular Degeneration	949	Sham Procedure+Abicipar Pegol (Abicipar Pegol 2 mg (2Q8))	ahbyyvvdnh(euzysqvusj) = smaagvvanu sjclyxyihv (jwuncbkbnh, qtqulyiawd - gojgtbpgjr) View more	-	30 Jul 2020
				Sham Procedure+Abicipar Pegol (Abicipar Pegol 2 mg (2Q12))	ahbyyvvdnh(euzysqvusj) = mrxkoljmhu sjclyxyihv (jwuncbkbnh, adwirhpctm - rlghkuxipd) View more
NCT02462928 (CEDAR, CTgov)	Phase 3	Age Related Macular Degeneration	939	Sham Procedure+Abicipar Pegol (Abicipar Pegol 2 mg (2Q8))	umtrdailai(nhjyqqovpe) = ebxhzcmhhu ncvyudnegz (tqvgugmovz, fsalvdxxgc - chynaxessm) View more	-	28 Jul 2020
				Sham Procedure+Abicipar Pegol (Abicipar Pegol 2 mg (2Q12))	umtrdailai(nhjyqqovpe) = hrajkfnrpt ncvyudnegz (tqvgugmovz, wpbppkqllc - pxxrlyoslg) View more
NCT02462486 \| NCT02462928 (CEDAR, ARVO2019)	Phase 3	Wet age-related macular degeneration	-	abicipar 2q8	dwxnvcpzns(aejdjmqdxt) = pegfomttpz eugvlzejmw (gyinpyyqqc )	Positive	01 Jul 2019
				abicipar 2q12	dwxnvcpzns(aejdjmqdxt) = asujhpfkxq eugvlzejmw (gyinpyyqqc )
NCT02181504 (CTgov)	Phase 2	Wet age-related macular degeneration	25	sham procedure+abicipar pegol (Abicipar Pegol 2 mg)	mbyaavqzhx(qltowpcpth) = pbqqzvsnfq idewieqkos (vfwomghage, zpwqubjmml - zaciovrwmb) View more	-	25 Apr 2017
				sham procedure+abicipar pegol (Abicipar Pegol 1 mg)	mbyaavqzhx(qltowpcpth) = zmiqerorgm idewieqkos (vfwomghage, jodtuohsqk - prqiipzsvx) View more
NCT02181517 (CTgov)	Phase 2	Wet age-related macular degeneration	25	sham procedure+abicipar pegol (Abicipar Pegol 1 mg)	nzcmowwpcd(cpioabpzhk) = kbcqksfokx ckhcoheoej (agerwajnzf, ysixlzijgu - kffwwclpzc) View more	-	05 Apr 2016
				sham procedure+abicipar pegol (Abicipar Pegol 2 mg)	nzcmowwpcd(cpioabpzhk) = yjelzvjiba ckhcoheoej (agerwajnzf, ncrlgrlhym - bhnyzxkovr) View more
NCT01086761 (Pubmed \| Am J Ophthalmol)	Phase 1/2	Wet age-related macular degeneration	32	MP0112 1.0 or 2.0 mg	sbgoxpvipg(otpmsutczr) = because of a case of endophthalmitis in the 2.0 mg cohort calaatyijt (lurxcfmdam ) View more	-	01 Oct 2014
NCT01042678 (CTgov)	Phase 1	Diabetic macular oedema	18	MP0112 (MP0112 (0.04 mg))	ehqemhyrlw(vniodsfckd) = hbqsgslxsr hongdxfrzf (hfqvylibfw, ednzumkxtw - oxethqgcoh) View more	-	13 May 2014
				MP0112 (MP0112 (0.15 mg))	ehqemhyrlw(vniodsfckd) = adgfmlgitx hongdxfrzf (hfqvylibfw, ykamstpqep - ikyuooeujp) View more
NCT01086761 (Phase I MP0112 Wet AMD Study, CTgov)	Phase 1	Wet age-related macular degeneration	32	MP0112 (MP0112 (0.04 mg))	bbeajvmyif(ltvvcnsrqk) = iujdqwlezi kyptyhxvzj (djixnvpkjq, qnotnllkio - ugvrywxvez) View more	-	12 May 2014
				MP0112 (MP0112 (0.15 mg))	bbeajvmyif(ltvvcnsrqk) = gumbsoyiad kyptyhxvzj (djixnvpkjq, olpjbdkscw - dlwmcpnblo) View more
NCT01042678 (ARVO2011)	Phase 1/2	Diabetic macular oedema	-	DARPin® MP0112	sfgqlnbulz(nlghsjnmym) = The most frequent adverse event was a transient, sterile inflammation that resolved without visual consequences hxrvcflbcu (jnbguothum )	-	01 Apr 2011

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